 |
| |
Please click here if you wish to skip directly to your Table of Contents listing the most recent Abstract Database additions.
Please click here if you wish to skip directly to the Table of Contents below. To learn more about our MedIntelliBase Custom Email Alerts, click here to complete our request form or contact us directly. Please click here to learn how to use this alert. |
(A small sampling of results from a December 1, 2006 to January 31,
2007 MIB Abstract Alert search) |
|
Go to Archive |
Patient-specific analysis of the volume of tissue activated during deep brain stimulation.
Neuroimage. 2007 Jan 15;34(2):661-70. Epub 2006 Nov 17.
Butson CR, Cooper SE, Henderson JM, McIntyre CC.
Department of Biomedical Engineering, Cleveland Clinic, Cleveland, OH 44195, USA.
Despite the clinical success of deep brain stimulation (DBS) for the treatment of movement disorders, many questions remain about its effects on the nervous system. This study presents a methodology to predict the volume of tissue activated (VTA) by DBS on a patient-specific basis. Our goals were to identify the intersection between the VTA and surrounding anatomical structures and to compare activation of these structures with clinical outcomes. The model system consisted of three fundamental components: (1) a 3D anatomical model of the subcortical nuclei and DBS electrode position in the brain, each derived from magnetic resonance imaging (MRI); (2) a finite element model of the DBS electrode and electric field transmitted to the brain, with tissue conductivity properties derived from diffusion tensor MRI; (3) VTA prediction derived from the response of myelinated axons to the applied electric field, which is a function of the stimulation parameters (contact, impedance, voltage, pulse width, frequency). We used this model system to analyze the effects of subthalamic nucleus (STN) DBS in a patient with Parkinson's disease. Quantitative measurements of bradykinesia, rigidity, and corticospinal tract (CST) motor thresholds were evaluated over a range of stimulation parameter settings. Our model predictions showed good agreement with CST thresholds. Additionally, stimulation through electrode contacts that improved bradykinesia and rigidity generated VTAs that overlapped the zona incerta/fields of Forel (ZI/H2). Application of DBS technology to various neurological disorders has preceded scientific characterization of the volume of tissue directly affected by the stimulation. Synergistic integration of clinical analysis, neuroimaging, neuroanatomy, and neurostimulation modeling provides an opportunity to address wide ranging questions on the factors linked with the therapeutic benefits and side effects of DBS.
PreMedline Identifier:
17113789
***To access this PubMed use the PreMedline Identifier in the PubMed search field. |
| Contact us for assistance |
|
Subthalamic nucleus stimulation modulates afferent inhibition in Parkinson disease.
Neurology. 2007 Jan 30;68(5):356-63.
Sailer A, Cunic DI, Paradiso GO, Gunraj CA, Wagle-Shukla A, Moro E, Lozano AM, Lang AE, Chen R.
Division of Neurology, Krembil Neuroscience Centre and Toronto Western Research Institute, University of Toronto, Toronto, Ontario, Canada.
BACKGROUND: Peripheral sensory stimulation at the wrist inhibits the motor cortex as measured by transcranial magnetic stimulation at interstimulus intervals of approximately 20 ms (short latency afferent inhibition [SAI]) and 200 ms (long latency afferent inhibition [LAI]). Previous studies suggested that reduced SAI in Parkinson disease (PD) reflects adverse effect of dopaminergic medications and reduced LAI may be related to nondopaminergic manifestations of PD. We hypothesize that subthalamic nucleus (STN) deep brain stimulation (DBS) may correct these deficiencies. METHODS: We studied the effects of STN DBS on SAI and LAI in seven PD patients and age-matched controls. PD patients were studied in an off medication followed by an on medication session, with the stimulator switched on or off in random order in each session. RESULTS: In the on medication session, SAI was reduced in the stimulator off condition and was restored by STN DBS. LAI was partially normalized by STN DBS in the medication on condition. CONCLUSIONS: Subthalamic nucleus (STN) stimulation improves short latency afferent inhibition, suggesting that it could normalize pathways that are adversely affected by dopaminergic medications. The effect of STN stimulation on long latency afferent inhibition suggests that it may influence nondopaminergic pathways involved in sensorimotor integration.
PreMedline Identifier:
17261682
***To access this PubMed use the PreMedline Identifier in the PubMed search field. |
| Contact us for assistance |
|
Effect of daily repetitive transcranial magnetic stimulation on motor performance in Parkinson's disease.
Mov Disord. 2006 Dec;21(12):2201-5.
Khedr EM, Rothwell JC, Shawky OA, Ahmed MA, Hamdy A.
Department of Neurology, Assiut University Hospital, Assiut, Egypt. emankhedr99@yahoo.com
Previous studies in patients with Parkinson's disease have reported that a single session of repetitive transcranial magnetic stimulation (rTMS) can improve some or all of the motor symptoms for 30 to 60 minutes. A recent study suggested that repeated sessions of rTMS lead to effects that can last for at least 1 month. Here we report data that both confirm and extend this work. Fifty-five unmedicated PD patients were classified into four groups: two groups (early and late PD) received 25 Hz rTMS bilaterally on the motor arm and leg areas; other groups acted as control for frequency (10 Hz) and for site of stimulation (occipital stimulation). All patients received six consecutive daily sessions (3,000 pulses for each session). The first two groups then received a further three booster sessions (3 consecutive days of rTMS) after 1, 2, and 3 months, while the third group had only one additional session after the first month. Unified Parkinson's Disease Rating Scale (UPDRS), walking time, key-tapping speed, and self-assessment scale were measured for each patient before and after each rTMS session and before and after the monthly sessions. Compared to occipital stimulation, 25 Hz rTMS over motor areas improved all measures in both early and late groups; the group that received 10 Hz rTMS improved more than the occipital group but less than the 25 Hz groups. The effect built up gradually during the sessions and was maintained for 1 month after, with a slight reduction in efficacy. Interestingly, the effect was restored and maintained for the next month by the booster sessions. We conclude that 25 Hz rTMS can lead to cumulative and long-lasting effects on motor performance. Copyright 2006 Movement Disorder Society
PreMedline Identifier:
17219616
***To access this PubMed use the PreMedline Identifier in the PubMed search field. |
| Contact us for assistance |
|
Transcranial magnetic stimulation over dorsolateral prefrontal cortex in Parkinson's disease.
Clin Neurophysiol. 2007 Jan;118(1):131-9. Epub 2006 Nov 9.
Del Olmo MF, Bello O, Cudeiro J.
Neuroscience and Motor Control Group (NEUROcom), University of A Coruna, A Coruna, Spain.
OBJECTIVE: Several studies have shown that repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (DLPFC) is effective in the treatment of depression in patients with Parkinson disease (PD). However, since research into the effect of this type of rTMS regime on motor function is limited, we studied the effect of rTMS over the DLPFC on the motor functions in PD patients. METHODS: Thirteen patients were randomly assigned into 2 groups, one receiving real-rTMS (90% of resting motor threshold, 10Hz, 450 pulses-day for 10 consecutive days) over the DLPFC contralateral to the more affected side, and the other group receiving sham-rTMS. Assessment included a clinical motor evaluation using part III of the Unified Parkinson's Disease Rating Scale (UPDRS), and several motor tasks. The UPDRS was applied before and after 10 days of rTMS. Finger tapping, reach movement, grip movement and gait were measured in each session before and after the rTMS over the 10 day period. RESULTS: Statistical analysis (ANOVA for repeated measures; group *day *side *rTMS) only showed a significant effect for finger tapping, reach movement and gait for the factor day. No significant change was reported for the UPDRS in any group. CONCLUSIONS: Application of rTMS over the DLPFC as a 10 day course had no significant effect on motor functions and clinical motor status, and the improvement in performance of motor tasks can be attributed to the effects of practice. SIGNIFICANCE: rTMS over the DLPFC did not lead to any motor improvement in PD patients.
PreMedline Identifier:
17097342
***To access this PubMed use the PreMedline Identifier in the PubMed search field. |
| Contact us for assistance |
|
Modulation of human motor cortex excitability by single doses of amantadine.
Neuropsychopharmacology. 2006 Dec;31(12):2758-66. Epub 2006 Jun 14
Reis J, John D, Heimeroth A, Mueller HH, Oertel WH, Arndt T, Rosenow F.
Department of Neurology, Interdisciplinary Epilepsy Center, Philipps-University, Marburg, Germany.
Amantadine-sulfate has been used for several decades to treat acute influenza A, Parkinson's disease (PD), and acute or chronic drug-induced dyskinesia. Several mechanisms of actions detected in vivo/in vitro including N-methyl-D-aspartate (NMDA)-receptor antagonism, blockage of potassium channels, dopamine receptor agonism, enhancement of noradrenergic release, and anticholinergic effects have been described. We used transcranial magnetic stimulation (TMS) to evaluate the effect of single doses of amantadine on human motor cortex excitability in normal subjects. Using a double-blind, placebo-controlled, crossover study design, motor thresholds, recruitment curves, cortical stimulation-induced silent period (CSP), short intracortical inhibition (ICI), intracortical facilitation (ICF), and late inhibition (L-ICI) in 14 healthy subjects were investigated after oral doses of 50 and 100 mg amantadine with single and paired pulse TMS paradigms. Spinal cord excitability was investigated by distal latencies and M-amplitudes of the abductor digiti minimi muscle. After intake of amantadine, a significant dose-dependent decrease of ICF was noticed as well as a significant increase of L-ICI as compared to placebo. The effect on ICF and L-ICI significantly correlated with amantadine serum levels. ICI was slightly increased after amantadine intake, but the effect failed to be significant. Furthermore, amantadine had no significant effects on motor thresholds, MEP recruitment curves, CSP, or peripheral excitability. In conclusion, a low dose of amantadine is sufficient in modulating human motor cortex excitability. The decrease of ICF and increase of L-ICI may reflect glutamatergic modulation or a polysynaptic interaction of glutamatergic and GABA-ergic circuits. Although amantadine has several mechanisms of action, the NMDA-receptor antagonism seems to be the most relevant effect on cortical excitability. As L-ICI can be influenced by this type of drug, it may be an interesting parameter for studies of motor learning and use-dependent plasticity.
PreMedline Identifier:
16794570
***To access this PubMed use the PreMedline Identifier in the PubMed search field. |
| Contact us for assistance |
|
Subthalamic Nucleus Stimulation in Parkinson's Disease Patients Intolerant to Levodopa.
Stereotact Funct Neurosurg. 2007 Jan 26;85(4):169-174 [Epub ahead of print]
Lyons KE, Davis JT, Pahwa R.
University of Kansas Medical Center, Department of Neurology, Kansas City, Kans., USA.
Levodopa responsiveness has been shown to be the best predictor of improvement after subthalamic nucleus (STN) deep brain stimulation (DBS) for Parkinson's disease (PD). The objective of this study was to assess the effect of STN DBS on PD patients intolerant to levodopa due to severe acute side effects such as intolerable nausea. There were 10 patients in the study who received STN DBS for PD. Five patients who were intolerant to levodopa were matched based on age, disease duration, sex and presurgical disease severity to 5 patients taking levodopa and demonstrating a good levodopa response. Both groups had a significant improvement in Unified Parkinson's Disease Rating Scale activities of daily living and motor subscales as well as tremor, rigidity and bradykinesia scores at 3, 6 and 12 months after surgery compared to baseline, and these improvements were equivalent between the two groups. Patient global ratings also indicated significant improvements at all follow-up visits. There were no differences in stimulator settings between the two groups at the 3-, 6- or 12-month follow-up visits. In conclusion, although levodopa responsiveness is the best predictor for outcome after STN DBS, carefully selected PD patients intolerant to levodopa can have significant improvement. Copyright (c) 2007 S. Karger AG, Basel.
PreMedline Identifier:
17259749
***To access this PubMed use the PreMedline Identifier in the PubMed search field. |
| Contact us for assistance |
|
Bilateral deep brain stimulation of the pedunculopontine and subthalamic nuclei in severe Parkinson's disease.
Brain. 2007 Jan 24; [Epub ahead of print]
Stefani A, Lozano AM, Peppe A, Stanzione P, Galati S, Tropepi D, Pierantozzi M, Brusa L, Scarnati E, Mazzone P.
IRCCS Fondazione St Lucia, Clinica Neurologica, Dipartimento di Neuroscienze, Universita di Roma Tor Vergata, Unita Operativa di Neurochirurgia Funzionale e Stereotassica, Ospedale CTO 'A. Alesini', ASL RMC, Unita Operativa di Neurologia, Ospedale S. Eugenio, Roma, Department of Biomedical Technology, University of L' Aquila, L'Aquila, Italy and Toronto Western Hospital, Research Institute, University of Toronto, Toronto, ON, Canada.
Gait disturbances and akinesia are extremely disabling in advanced Parkinson's disease. It has been suggested that modulation of the activity of the pedunculopontine nucleus (PPN) may be beneficial in the treatment of these symptoms. We report the clinical affects of deep brain stimulation (DBS) in the PPN and subthalamic nucleus (STN). Six patients with unsatisfactory pharmacological control of axial signs such as gait and postural stability underwent bilateral implantation of DBS electrodes in the STN and PPN. Clinical effects were evaluated 2-6 months after surgery in the OFF- and ON-medication state, with both STN and PPN stimulation ON or OFF, or with only one target being stimulated. Bilateral PPN-DBS at 25 Hz in OFF-medication produced an immediate 45% amelioration of the motor Unified Parkinson's Disease Rating Scale (UPDRS) subscale score, followed by a decline to give a final improvement of 32% in the score after 3-6 months. In contrast, bilateral STN-DBS at 130-185 Hz led to about 54% improvement. PPN-DBS was particularly effective on gait and postural items. In ON-medication state, the association of STN and PPN-DBS provided a significant further improvement when compared to the specific benefit mediated by the activation of either single target. Moreover, the combined DBS of both targets promoted a substantial amelioration in the performance of daily living activities. These findings indicate that, in patients with advanced Parkinson's disease, PPN-DBS associated with standard STN-DBS may be useful in improving gait and in optimizing the dopamine-mediated ON-state, particularly in those whose response to STN only DBS has deteriorated over time. This combination of targets may also prove useful in extra-pyramidal disorders, such as progressive supranuclear palsy, for which treatments are currently elusive.
PreMedline Identifier:
17251240
***To access this PubMed use the PreMedline Identifier in the PubMed search field. |
| Contact us for assistance |
|
Is a computational model useful to understand the effect of deep brain stimulation in Parkinson's disease?
J Integr Neurosci. 2006 Dec;5(4):541-59.
Pascual A, Modolo J, Beuter A.
Institute of Mathematics, Universities Bordeaux 1 and Bordeaux 2, 146 Rue Leo Saignat, 33076 Bordeaux, France. apascual@fing.edu.uy.
A growing number of computational models have been proposed over the last few years to help explain the therapeutic effect of deep brain stimulation (DBS) on motor disorders in Parkinson's disease (PD). However, none of these has been able to explain in a convincing manner the physiological mechanisms underlying DBS. Can these models really contribute to improving our understanding? The model by Rubin and Terman [31] represents one of the most comprehensive and biologically plausible models of DBS published recently. We examined the validity of the model, replicated its simulations and tested its robustness. While our simulations partially reproduced the results presented by Rubin and Terman [31], several issues were raised including the high complexity of the model in its non simplified form, the lack of robustness of the model with respect to small perturbations, the nonrealistic representation of the thalamus and the absence of time delays. Computational models are indeed necessary, but they may not be sufficient in their current forms to explain the effect of chronic electrical stimulation on the activity of the basal ganglia (BG) network in PD.
PreMedline Identifier:
17245822
***To access this PubMed use the PreMedline Identifier in the PubMed search field. |
| Contact us for assistance |
|
Localization of electrodes in the subthalamic nucleus on magnetic resonance imaging.
J Neurosurg. 2007 Jan;106(1):36-44.
Pollo C, Vingerhoets F, Pralong E, Ghika J, Maeder P, Meuli R, Thiran JP, Villemure JG.
Department of Neurosurgery, Neurosurgical Neurophysiology Institute, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland. Claudio.Pollo@chuv.hospvd.ch
OBJECT: The authors describe a new method of localizing electrodes on magnetic resonance (MR) images and focus on the positions of both the most efficient contact and the electrode related to the MR imaging target. METHODS: Thirty-one patients who had undergone bilateral subthalamic nucleus (STN) deep brain stimulation (DBS) were included in this study. Target coordinates were calculated in the anterior commissure-posterior commissure referential. A study of the correlation between the artifact and the related contact allowed one to deduce the contact position from the identification of the distal artifact on MR imaging. The best stimulation point corresponded with the contact resulting in the best Unified Parkinson's Disease Rating Scale (UPDRS) motor score improvement. It was compared (Student t-test) with the dorsal margin of the STN (DM STN), which was determined electrophysiologically. The distance between the target and the electrode was calculated individually in each axis. The best stimulation point was located at anteroposterior -2.34 +/- 1.63 mm, lateral 12.04 +/- 1.62 mm, and vertical -2.57 +/- 1.68 mm. This point was not significantly different from the DM STN (p < 0.05). The postoperative UPDRS motor score was 28.07 +/- 12.16, as opposed to the preoperative score of 46.27 +/- 13.89. The distance between the expected and actual target in the x- and y-axes was 1.34 +/- 1.02 and 1.03 +/- 0.76 mm, respectively. In the z-axis, 39.7% of the distal contacts were located proximal to the target. CONCLUSIONS: This approach proposed for the localization of the electrodes on MR imaging shows that DBS is most effective in the dorsal and lateral part of the STN and indicates that the DBS electrode can be located more proximally than originally expected because of the caudal brain shift that may occur during the implantation procedure.
PreMedline Identifier:
17240554
***To access this PubMed use the PreMedline Identifier in the PubMed search field. |
| Contact us for assistance |
|
Statistical determination of the optimal subthalamic nucleus stimulation site in patients with Parkinson disease.
J Neurosurg. 2007 Jan;106(1):101-10.
Guehl D, Edwards R, Cuny E, Burbaud P, Rougier A, Modolo J, Beuter A.
Service de Neurophysiologie Clinique, Hopital Pellegrin, Universite de Bordeaux, France.
OBJECT: The subthalamic nucleus (STN) is currently recognized as the preferred target for deep brain stimulation (DBS) in patients with Parkinson disease (PD). If there is agreement in the literature that DBS improves motor symptoms significantly, the situation is less clear with respect to the side effects of this procedure. The goal of this study was to correlate the coordinate values of active electrode contacts with the amplitude of residual clinical symptoms and side effects using a mathematical approach. METHODS: In this study the investigators examined a cohort of 41 patients with PD who received clinical benefits from DBS after stimulating electrodes had been implanted bilaterally into the STN. The combined scores of residual clinical symptoms plus side effects, including speech disturbance, postural instability, and weight gain, were fitted by using either inverted ellipsoidal exponefitials or smooth splines. These analyses showed evidence of lower combined scores for stimulating contacts at an x coordinate approximately 12.0 to 12.3 mm lateral to the anterior commissure-posterior commissure (AC-PC) line and at a z coordinate approximately 3.1 to 3.3 mm under the AC-PC line. There was insufficient evidence for a preferred y coordinate location. CONCLUSIONS: The authors propose a "best" therapeutic ellipse area that is centered at an x, z location of 12.5 mm, -3.3 mm and characterized by an extension of 1.85 mm in the x direction and 2.22 mm in the z direction. Therapeutic electrode contacts located within this area are well correlated with the lowest occurrence of residual symptoms and the lowest occurrence of side effects independent of STN anatomical considerations. The lack of a significant result in the y direction remains to be explored further.
PreMedline Identifier:
17236495
***To access this PubMed use the PreMedline Identifier in the PubMed search field. |
| Contact us for assistance |
|
Impaired motor imagery in patients with essential tremor: A case control study.
Mov Disord. 2007 Jan 16; [Epub ahead of print]
Lo YL, Louis ED, Fook-Chong S, Tan EK.
Department of Neurology, Singapore General Hospital, Singapore.
Motor imagery (MI), which refers to the process of mental representation of movements, has not been studied in patients with essential tremor (ET). We investigated the presence of impaired MI in ET patients compared with healthy controls. A group of drug-naive and nondemented ET patients and age-matched controls were studied using transcranial magnetic stimulation, while they were specifically instructed to try and imagine themselves performing two motor tasks. The various clinical and electrophysiological variables were evaluated and compared. Repeated measures ANOVA demonstrated a significant difference between ET patients and controls with respect to mean motor-evoked potential (MEP) amplitudes (F(1,38) = 31.92, P < 0.005) during MI. The process of MI effectively facilitated MEP amplitude in controls but not in ET patients, regardless of side of stimulation or motor tasks. We provide evidence to demonstrate impairment of MI in a group of ET patients compared with healthy controls. The basis for this novel finding is unclear, and further studies are warranted to determine whether it is related to cerebellar or motor cortical dysfunction. (c) 2007 Movement Disorder Society.
PreMedline Identifier:
17226857
***To access this PubMed use the PreMedline Identifier in the PubMed search field. |
| Contact us for assistance |
|
Deep brain stimulation in neurologic disorders.
Parkinsonism Relat Disord. 2007 Feb;13(1):1-16. Epub 2006 Dec 1.
Halpern C, Hurtig H, Jaggi J, Grossman M, Won M, Baltuch G.
Department of Neurology, Penn Neurological Institute at Pennsylvania Hospital, Hospital of the University of Pennsylvania, Philadelphia, PA, USA; Department of Neurosurgery, Penn Neurological Institute at Pennsylvania Hospital, Hospital of theUniversity of Pennsylvania, Philadelphia, PA, USA.
Deep brain stimulation (DBS) is an effective surgical therapy for well-selected patients with medically intractable Parkinson's disease (PD) and essential tremor (ET). The purpose of this review is to describe the success of DBS in these two disorders and its promising application in dystonia, Tourette Syndrome (TS) and epilepsy. In the last 10 years, numerous short- and intermediate-term outcome studies have demonstrated significant relief to patients with PD and ET. A few long-term follow-up studies have also reported sustained benefits. When successful, DBS greatly reduces most of parkinsonian motor symptoms and drug-induced dyskinesia, and it frequently improves patients' ability to perform activities of daily living with less encumbrance from motor fluctuations. Quality of life is enhanced and many patients are able to significantly reduce the amount of antiparkinsonian medications required to still get good pharmacological benefit. Overall, adverse effects associated with DBS tend to be transient, although device-related and other postoperative complications do occur. DBS should be considered the surgical procedure of choice for patients who meet strict criteria with medically intractable PD, ET and selected cases of dystonia.
PreMedline Identifier:
17141550
***To access this PubMed use the PreMedline Identifier in the PubMed search field. |
| Contact us for assistance |
|
Computerized posturography balance assessment of patients with bilateral ventralis intermedius nuclei deep brain stimulation.
Mov Disord. 2006 Dec;21(12):2243-7.
Ondo WG, Almaguer M, Cohen H.
Department of Neurology, Baylor College of Medicine, Houston, Texas, USA. wondo@bcm.tmc.edu
Bilateral ventralis intermedius nuclei (Vim) deep brain stimulation (DBS) improves tremor in patients with both essential tremor (ET) and Parkinson's disease (PD). In each condition, patients have individually noted both subjective improvement and worsening in balance. Computerized posturography (CP) is able to quantify some aspects of balance. Twenty-one patients (8 with PD and 13 with ET) with bilateral Vim DBS were recruited to undergo randomized-order identical CP testing (EquiTest system) while their DBS devices were both activated and deactivated. One PD patient could not complete any OFF assessment and is not included. Three PD patients could not tolerate portions of the OFF testing. Overall, sensory organization testing was improved by DBS activation in conditions that involved quiet standing with eyes open with no motion of the support surface, or with sway-referenced support surface motion, but worsened during quiet standing with eyes closed only in ET patients. Falls lessened with activation in ET patients. Motor control testing was not changed. Bilateral Vim DBS activation mostly improved balance, but may modestly worsen other specific features. Copyright 2006 Movement Disorder Society.
PreMedline Identifier:
17078067
***To access this PubMed use the PreMedline Identifier in the PubMed search field. |
| Contact us for assistance |
|
| |
Advanced Neuromodulation Systems Secures European Approval for Rapid Programmer 3.0 Clinician Programming Platform
Wireless News. Coventry: Jan 18, 2007. pg. 1
WIRELESS NEWS-January 18, 2007-Advanced Neuromodulation Systems Secures European Approval for Rapid Programmer 3.0 Clinician Programming Platform (C)2007 10Meters - http://www.10meters.com
Advanced Neuromodulation Systems (ANS), the neuromodulation business of St. Jude Medical, announced European CE Mark approval for its newest clinician programming platform, Rapid Programmer 3.0 for spinal cord stimulation (SCS), an advanced therapy for managing chronic pain.
Coinciding with the approval, ANS has launched an upgraded version of its rechargeable spinal cord stimulation device, the Eon with NeuroDynamix technology. The Eon's proprietary new microchip and enhanced software, together with Rapid Programmer 3.0, create a sophisticated system to provide patients with customized pain coverage.
Spinal cord stimulators like Eon are used to treat patients suffering with chronic intractable pain. These "pacemakers for pain" interrupt the pain signals' pathway to the brain by delivering low intensity electrical pulses to selective nerve fibers along the spinal cord. More than 30,000 patients worldwide have been implanted with ANS neurostimulation systems to help alleviate their chronic pain.
"The enhanced Eon and the new Rapid Programmer platform work together as an integrated system to provide clinicians greater speed, power, efficiency and precision for helping patients address complex pain," said Chris Chavez, president of Advanced Neuromodulation Systems.
Proquest Identifier: 1197057241
* To access this Proquest article the user must create an account.
|
| Contact us for assistance |
|
Cyberonics Could Be Acquisition Target With Permanent CEO Slot Left Open
The Gray Sheet. Chevy Chase: Dec 4, 2006. Vol. 32, Iss. 49; pg. 12
Adosh Unni
<No Abstract Available>
Proquest Identifier: 1189816571
* To access this Proquest article the user must create an account.
|
| Contact us for assistance |
|
Combined ketogenic diet and vagus nerve stimulation: rational polytherapy?
Epilepsia. 2007 Jan;48(1):77-81.
Kossoff EH, Pyzik PL, Rubenstein JE, Christina Bergqvist AG, Buchhalter JR, Donner EJ, Nordli DR Jr, Wheless JW.
The Johns Hopkins Hospital, Baltimore, Maryland.
Objective: The concept of "rational polypharmacy" has been associated with anticonvulsant management for decades, but the term has not been applied to nonpharmacologic therapies. Methods: We conducted a multicenter, retrospective study of children who received concurrent diet (ketogenic or modified Atkins) and vagus nerve stimulation (VNS) treatment for medically intractable epilepsy. Results: Thirty children in total from six epilepsy centers were treated over a 6-yr period. The median age at the initiation of combination therapy was 10 yr (range, 4-24 yr). Sixteen (53%) received dietary therapy followed by VNS; no differences were noted between centers. After 3 months, 21 (70%) had seizure reduced by >50% over the previous single nonpharmacologic treatment, of whom 13 (62%) had improvement within the first month. A 5-min VNS off-time correlated with >90% seizure reduction (p = 0.02). The median duration of nonpharmacologic polytherapy was 12 months (range, 0.5-96 months); 17 (57%) remain on dual therapy at this time. No side effects were noted. Most patients who discontinued combination therapy did so because of a lack of efficacy rather than restrictiveness. Conclusions: In this small group, the combined use of diet and VNS appeared synergistic and yielded rapid benefits. It may be more effective with longer VNS off-times. Further prospective studies of this combination in refractory pediatric epilepsy are needed to help guide optimal use.
PreMedline Identifier: 17241211
***To access this PubMed use the PreMedline Identifier in the PubMed search field. |
| Contact us for assistance |
|
Serial Vagus Nerve Stimulation Functional MRI in Treatment-Resistant Depression.
Neuropsychopharmacology. 2007 Jan 3; [Epub ahead of print]
Nahas Z, Teneback C, Chae JH, Mu Q, Molnar C, Kozel FA, Walker J, Anderson B, Koola J, Kose S, Lomarev M, Bohning DE, George MS.
[1] 1Department of Psychiatry, Brain Stimulation Laboratory, Mood Disorders Program, Institute of Psychiatry, Charleston, SC, USA [2] 2Department of Radiology, Radiology and Center for Advanced Imaging Research, Medical University of South Carolina, Charleston, SC, USA.
Vagus nerve stimulation (VNS) therapy has shown antidepressant effects in open acute and long-term studies of treatment-resistant major depression. Mechanisms of action are not fully understood, although clinical data suggest slower onset therapeutic benefit than conventional psychotropic interventions. We set out to map brain systems activated by VNS and to identify serial brain functional correlates of antidepressant treatment and symptomatic response. Nine adults, satisfying DSM-IV criteria for unipolar or bipolar disorder, severe depressed type, were implanted with adjunctive VNS therapy (MRI-compatible technique) and enrolled in a 3-month, double-blind, placebo-controlled, serial-interleaved VNS/functional MRI (fMRI) study and open 20-month follow-up. A multiple regression mixed model with blood oxygenation level dependent (BOLD) signal as the dependent variable revealed that over time, VNS therapy was associated with ventro-medial prefrontal cortex deactivation. Controlling for other variables, acute VNS produced greater right insula activation among the participants with a greater degree of depression. These results suggest that similar to other antidepressant treatments, BOLD deactivation in the ventro-medial prefrontal cortex correlates with the antidepressant response to VNS therapy. The increased acute VNS insula effects among actively depressed participants may also account for the lower dosing observed in VNS clinical trials of depression compared with epilepsy. Future interleaved VNS/fMRI studies to confirm these findings and further clarify the regional neurobiological effects of VNS.Neuropsychopharmacology advance online publication, 3 January 2007; doi:10.1038/sj.npp.1301288.
PreMedline Identifier: 17203016
***To access this PubMed use the PreMedline Identifier in the PubMed search field. |
| Contact us for assistance |
|
Vagus nerve stimulation therapy in depression and epilepsy: therapeutic parameter settings.
Acta Neurol Scand. 2007 Jan;115(1):23-33.
Labiner DM, Ahern GL.
Department of Neurology, University of Arizona Health Sciences Center, Tucson, AZ, USA.
Vagus nerve stimulation (VNS) therapy is an effective adjunctive treatment for chronic or recurrent treatment-resistant depression in adults, and for pharmacoresistant epilepsy in adults and adolescents. VNS therapy is administered through an implanted pulse generator that delivers programmed electrical pulses through an implanted lead to the left vagus nerve. Programmable pulse parameters include output current, frequency, pulse width, and ON/OFF times. Within a range of typical values, individual patients respond best to different combinations of parameter settings. The physician must identify the optimum settings for each patient while balancing the goals of maximizing efficacy, minimizing side effects, and preserving battery life. Output current is gradually increased from 0.25 mA to the maximum tolerable level (maximum, 3.5 mA); typical therapeutic settings range from 1.0 to 1.5 mA. Greater output current is associated with increased side effects, including voice alteration, cough, a feeling of throat tightening, and dyspnea. Frequency is typically programmed at 20 Hz in depression and 30 Hz in epilepsy. Pulse width is typically 250 or 500 mus. The recommended initial ON time is 30 s, followed by 5 min OFF; OFF time > ON time is recommended. As with pharmacotherapy, VNS therapy must be adjusted in a gradual, systematic fashion to individualize therapy for each patient.
PreMedline Identifier: 17156262
***To access this PubMed use the PreMedline Identifier in the PubMed search field. |
| Contact us for assistance |
|
Vagus nerve stimulation (VNS) for depression: what do we know now and what should be done next?
Curr Psychiatry Rep. 2006 Dec;8(6):445-51.
Nahas Z, Burns C, Foust MJ, Short B, Herbsman T, George MS.
Mood Disorders Program, Medical Director of Brain Stimulation Laboratory; Institute of Psychiatry, 67 President Street, Room 502 North, Charleston, SC 29403, USA. nahasz@musc.edu
Vagus nerve stimulation (VNS) therapy is the first US Food and Drug Administration-approved somatic clinical intervention for treatment-resistant depression (TRD). Long-term open data suggest a sustainable antidepressant response over time. Here we review the clinical data that exist so far and their limitations. We also discuss guidelines that may inform the clinical utilization of this procedure. Further clinical studies, in addition to prospective cost utilization and health economic investigations, are needed to better understand VNS therapy and the impact it holds on TRD care.
PreMedline Identifier: 17094924
***To access this PubMed use the PreMedline Identifier in the PubMed search field. |
| Contact us for assistance |
|
Responding to three articles regarding vagus nerve stimulation (VNS) for depression.
Biol Psychiatry. 2006 Dec 15;60(12):1382; author reply 1382-3. Epub 2006 Aug 24.
Lurie P, Stine N.
<No Abstract Available>
PreMedline Identifier: 16934767
***To access this PubMed use the PreMedline Identifier in the PubMed search field. |
| Contact us for assistance |
|
Cyberonics Sends Letter to Stockholders; Urges Stockholders to Reelect Board's Highly Qualified Nominees
PR Newswire. New York: Jan 24, 2007. pg. n/a
January 24, 2007
Dear Fellow Cyberonics Stockholder,
Cyberonics' February 1st Annual Meeting of Stockholders is rapidly approaching, and your vote is important, no matter how many, or how few, shares you own. We urge you to support your Board of Directors by signing, dating and returning the enclosed WHITE proxy card today.
In advance of the Annual Meeting, members of our Board and management team have been meeting with stockholders to have open discussions about the future of our Company. We have appreciated the opportunity to exchange ideas and share our vision of Cyberonics' bright future. While we did not seek out this proxy contest -- and indeed, sought to avoid it -- we are grateful for the opportunity it has provided us to meet with you and benefit from your insights. We are resolutely focused on creating stockholder value, and we are actively executing on a strategy designed to make it happen.
YOUR BOARD HAS IMPLEMENTED STRONG
CORPORATE GOVERNANCE SAFEGUARDS
You should be aware that your Board has proactively addressed a number of governance issues over the past year, even before this proxy contest began. For example, the Company has adopted an option grants policy with underlying work instructions that are meant to ensure tight administrative accountability. The work instructions describe the process for initiating, approving, and documenting all equity grants and the persons responsible for each step of the process. Among the highlights of the policy are:
-- Officers and directors are not eligible to receive options. Equity
grants to officers and directors will be limited to restricted stock.
This codifies a practice adopted in 2004.
-- Restricted stock grants to officers and directors can be made only
once each year on the date of the annual meeting.
-- Equity grants to other employees can be made only once each quarter in
the 7th week of the fiscal quarter. All paperwork for these grants
(other than Compensation Committee approval) must be complete by the
4th week of the quarter.
VOTING ADVISORY FIRM ISS RECOGNIZES OUR STEADILY INCREASING REVENUES, COST
CUTTING EFFORTS, AND INCREASING GROSS PROFIT MARGINS
In addition to recognizing a number of improvements our Board is making, we are pleased that Institutional Shareholder Services (ISS), a leading independent voting advisory service, recommended that Cyberonics stockholders vote to re-elect Cyberonics' Chairman, Tony Coelho, to the Cyberonics Board of Directors. In its January 22, 2007 report, ISS stated:
-- "[O]perationally the company has been able to steadily increase its
revenues, expand into international markets, and as a result of an
internal cost structure review, has been able to increase its gross
profit margins."*
-- "The company is awaiting favorable coverage from the large national
and regional insurance payers which may require close relationships
with constituencies such as lawmakers, regulators, providers and major
payers which could be critical to the company's success. We believe
that the presence of Tony Coelho on the board could enhance this
process, particularly given his experience and his position as the
chairman of the Epilepsy Foundation. As such, we believe that Tony
Coelho should continue as a director."*
-- "[W]e believe that replacement of Tony Coelho could negatively impact
the execution of the company's business plan, in particular obtaining
broad-based national and regional coverage policy for treatment using
the VNS device."*
* Permission to use quotations from the ISS report was neither sought
nor obtained.
OUR BOARD AND MANAGEMENT HAVE IN PLACE A STRATEGIC PLAN
We've heard in our meetings with stockholders that you would like a clearer understanding of our plan to create value and of the key milestones on the path ahead. We're proud of the actions we have already taken to position Cyberonics for continued success. As a result of these efforts, Cyberonics is now a stronger company with less risk and uncertainty. Our focus is on obtaining broad-based national and regional coverage policy for Vagus Nerve Stimulation Therapy (VNS Therapy) in treatment-resistant depress (TRD) more quickly than we did for refractory epilepsy.
As you may know, we expect to receive a proposed national coverage determination for VNS Therapy in TRD from the Centers for Medicare & Medicaid Services (CMS) on February 7, 2007. If favorable, this will be an important step forward in the quest for TRD coverage. During the first public comment period for our TRD coverage request, CMS received 1,329 public comments, 99.5% of which favored coverage for TRD, including comments from 258 psychiatric thought leaders and psychiatrists, 50 neurologists, more than 100 other healthcare professionals, 645 patients and family members, 41 patient advocacy groups, and more than 20 members of Congress.
Given the body of clinical evidence that VNS Therapy in TRD is safe and effective, and the overwhelming support among physicians and patients, CMS should propose a favorable coverage policy for our life-altering product. Even if CMS proposes a favorable coverage policy, however, our quest for coverage among major private payers and the sales growth that will accompany increased coverage must continue anew. In this regard, continuity on your Board is critical as the current Board members have relationships with key constituencies that are critical to our success, in particular, key contacts with lawmakers, regulators, providers and major payors -- our most important constituencies.
WE URGE YOU NOT TO JEOPARDIZE THE CONSIDERABLE SUCCESS WE HAVE ALREADY
ACHIEVED
Your Board unanimously recommends that Cyberonics stockholders vote to reelect the following highly qualified individuals: Stanley H. Appel, M.D., Tony Coelho, Guy C. Jackson, Kevin S. Moore, Hugh M. Morrison, Alan J. Olsen, Michael J. Strauss, M.D., M.P.H., and Reese S. Terry, Jr. Each of these directors possesses extensive and relevant experience, and relationships with key constituencies that are critical to the Company's success.
TIME IS SHORT. Protect your investment in Cyberonics TODAY by voting your shares by phone, by using the internet, or by signing, dating and returning the enclosed WHITE proxy card.
On behalf of your Board of Directors, thank you for your continued support.
TONY COELHO REESE S. TERRY, JR.
Proquest Identifier: 1201185931
* To access this Proquest article the user must create an account. |
| Contact us for assistance |
|
Epilepsy; Study data from University of Toronto, Canada, shed light on epilepsy research
Pain & Central Nervous System Week. Atlanta: Jan 15, 2007. pg. 386
2007 JAN 15 - (NewsRx.com) -- Epilepsy research advances have been reported from University of Toronto, Canada.
Study 1: Current study results from the report, "Status epilepticus after electroconvulsive therapy in a pregnant patient," have been published. According to recent research from Canada, "Status epilepticus after electroconvulsive therapy is a rare complication, and its occurrence during pregnancy has not been reported previously. We discuss the case of a 31-year-old primigravida at 22 weeks of gestation, with a history of bipolar disorder, who underwent electroconvulsive therapy under general anesthesia."
"Following three treatments she developed status epilepticus, requiring large doses of benzodiazepines, thiopental, propofol and diphenylhydantoin to control the seizure activity. She remained intubated and ventilated for several days after treatment with a complicated course. As a consequence, the fetus died," wrote M. Balki and colleagues, University of Toronto, Department of Anesthesia.
The researchers concluded: "We discuss the possible causes and the management of status epilepticus after electroconvulsive therapy during pregnancy and its implications for maternal and fetal outcome."
Balki and colleagues published their study in International Journal of Obstetric Anesthesia (Status epilepticus after electroconvulsive therapy in a pregnant patient. International Journal of Obstetric Anesthesia, 2006;15(4):325-8).
For additional information, contact M. Balki, Mount Sinai Hospital, Dept. of Anesthesia, University of Toronto, Ontario, Canada.
Study 2: The role of magnetoencephalography in pediatric epilepsy surgery is reviewed.
According to a study from Canada, "Magnetoencephalography (MEG) is a new diagnostic imaging and brain mapping device that has been recently used in the context of pediatric epilepsy, epilepsy surgery, and neuronavigation. MEG allows for the placement of magnetic spike sources on a conventional magnetic resonance imaging scan, the so-called magnetic source imaging, so that the localization of epileptiform activity in a child can be determined."
R. Grondin and colleagues, University of Toronto, wrote, "Considerable effort is placed on analyzing the configuration and number of spike waves by MEG that relate to a primary epileptiform discharge. Such MEG spike clusters are corroborated now by intraoperative invasive subdural grid monitoring that show good correlation in the majority of cases. Another important role of MEG relates to the mapping of critical regions of brain function using known paradigms for speech, motor, sensory, visual, and auditory brain cortex."
They continued, "When linked to standard neuronavigation devices, MEG brain mapping can be extremely helpful to the neurosurgeon approaching nonlesional epilepsy cases or lesional cases where the safest and most direct route to the surgical disease can be selected."
The researchers concluded, "As paradigms for brain mapping improve and as MEG software upgrades become more sensitive to analyzing all types of spike sources, MEG will play an increasingly important role in pediatric neurosurgery, especially for the child with intractable epilepsy."
Grondin and colleagues published their review in the Childs Nervous System (The role of magnetoencephalography in pediatric epilepsy surgery. Childs Nerv Syst, 2006;22(8):779-785).
For additional information, contact J.T. Rutka, University of Toronto, Hospital for Sick Children, Division Neurosurgery, 555 University Avenue, Toronto, ON M5G 1X8, Canada.
Study 3: Vagal nerve stimulation (VNS) implantation can be a safe and effective alternative therapy for children with drug-resistant epilepsy who are not candidates for epilepsy surgery.
According to recent research from Canada, "The management of intractable epilepsy in children is a challenging problem. For those patients who do not respond to antiepileptic drugs and are not candidates for epilepsy surgery, VNS can be a viable alternative for reducing seizure frequency. We have reviewed the historical and clinical background of VNS treatment. We also include our experience at The Hospital for Sick Children in children who underwent VNS implantation."
M. Benifla and colleagues, University of Toronto, wrote, "Forty- one children underwent VNS implantation for epilepsy over 6 years. After a mean follow-up of 31 months, 15 (38%) patients had a seizure frequency reduction of more than 90%. Fifteen (38%) children failed to respond to the VNS treatment. The device was removed in five children: in one, due to late infection; the other four could not tolerate the side effects of chronic VNS therapy. Two patients required reimplantation due to electrode failure. The most common side effects in our series were cough and vocal disturbances."
The researchers concluded, "Our results show that VNS implantation can be a safe and effective alternative therapy for children with drug-resistant epilepsy who are not candidates for epilepsy surgery."
Benifla and colleagues published their study in the Childs Nervous System (Vagal nerve stimulation for refractory epilepsy in children: indications and experience at The Hospital for Sick Children. Childs Nerv Syst, 2006;22(8):1018-1026).
For additional information, contact E.J. Donner, University of Toronto, Hospital for Sick Children, Division Neurology, 555 University Avenue, Toronto, ON M5G 1X8, Canada.
Proquest Identifier: 1191588011
* To access this Proquest article the user must create an account. |
| Contact us for assistance |
|
FDA Neuro Panel Will Review Cyperonics, Confluent Postmarket Data
The Gray Sheet. Chevy Chase: Jan 1, 2007. Vol. 33, Iss. 1; pg. 4
<No Abstract Available>
Proquest Identifier: 1195786981
* To access this Proquest article the user must create an account. |
| Contact us for assistance |
|
Business & Finance; Cyberonics revises sales guidance for first half of FY07
Physician Law Weekly. Atlanta: Dec 6, 2006. pg. 21
2006 DEC 6 - (NewsRx.com) -- Cyberonics, Inc. (CYBX) announced revised guidance for the second quarter and first six months of FY07.
Sales for the second quarter ended October 27, 2006 are expected to be approximately $34.1 million, compared to fiscal year 2006 second quarter sales of $29.1 million, reflecting annual growth of 17.4% from the same period last year. U.S. sales for the second quarter ended October 27, 2006 are expected to be approximately $29.5 million, and international sales are expected to be approximately $4.6 million.
Sales for the six months ended October 27, 2006 are expected to be approximately $67.9 million, compared to $56.1 million for the first six months of fiscal year 2006, reflecting annual growth of 21.0%. U.S. sales for the six months ended October 27, 2006 are expected to be approximately $59.1 million, and international sales are expected to be approximately $8.8 million.
Cash and marketable securities are expected to decrease from approximately $95 million at July 28, 2006 to approximately $94 million on October 27, 2006 and borrowings under the company's $40 million line of credit are expected to increase from $5.0 million on July 28, 2006 to $7.5 million on October 27, 2006. Expenses associated with the informal inquiry by the Securities and Exchange Commission (SEC), the subpoena from the Office of the United States Attorney for the Southern District of New York (U.S. Attorney), and the company's internal review of all stock option grants since February 1993 and related procedures and practices are expected to total approximately $7.2 million as of October 27, 2006.
Financial results and the Forms 10-Q for the quarters ended October 27, 2006 and July 28, 2006 as well as the Annual Report on Form 10-K for the year ended April 28, 2006 will be issued and filed upon completion of the previously announced internal review being conducted by the audit committee of the company's board of directors regarding stock option grants and resolution of any disclosure and accounting issues that may arise from the results of the review. The audit committee is working diligently to complete its internal review, and the company intends to release its results and file its Forms 10-Q and 10-K and hold its annual meeting as expeditiously as possible.
The company believes that it is not in the best interests of the stockholders to hold an annual meeting prior to filing its Forms 10- K and 10-Q because all of the company's stockholders should have access to current information regarding the financial condition, results of operations and business prospects of the company prior to casting a vote.
"Cyberonics remains firmly committed to, and continues to make progress towards the accomplishment of, its mission to improve the lives of people touched by refractory epilepsy or treatment- resistant depression (TRD)," commented Robert P. ("Skip") Cummins, Cyberonics' chairman of the board and chief executive officer.
"In the nine years since FDA approval for epilepsy, approximately 45,000 people with refractory epilepsy have accumulated approximately 150,000 years of experience with VNS Therapy. Although the coverage and reimbursement environment for new medical technologies is considerably more challenging today than it was in 1997 at the time of epilepsy approval, more than 2,200 TRD patients have received VNS Therapy since TRD approval in July 2005 versus approximately 1,300 refractory epilepsy patients who received VNS Therapy in the same time period after approval in 1997. However, more than 5,000 TRD patients have so far been denied access to VNS Therapy by their payers."
"TRD patients will achieve parity in access to VNS Therapy with epilepsy patients only through coverage policies," commented Shawn P. Lunney, vice president, market development. "In fiscal 2007, Cyberonics began formally requesting that payers' existing VNS Therapy coverage policies be amended to include patients with TRDEH, defined as TRD patients who were either previously (1) treated with or refused treatment with electroconvulsive therapy, or (2) hospitalized for depression.TRDEH is the most chronic, resistant, disabling, life-threatening and expensive form of major depressive disorder. Studies show that TRDEH patients, a relatively small subset of depressed patients, consume enormous and disproportionate resources.
"In August 2007, Cyberonics formally requested that the Centers for Medicare and Medicaid Services (CMS) reconsider its existing coverage policy for VNS Therapy to include patients with TRDEH. The first public comment period for Cyberonics' request for CMS reconsideration occurred in the second quarter. During that 30-day public comment period, CMS received a record 1,329 total comments from the public, 1,323 (99.5%) of which supported parity in access to VNS Therapy for Americans with TRDEH.
"The favorable comments came from 258 psychiatric thought leaders and psychiatrists, 50 neurologists, more than 100 other healthcare professionals, 645 patients and family members, 41 patient advocacy groups including NAMI, DBSA, NMHA and the Epilepsy Foundation and more than 20 members of Congress. We anticipate that CMS will post its draft policy for VNS in TRDEH and seek a final round of public comments in the fourth quarter of Cyberonics fiscal 2007.
"Although TRD patient access to VNS Therapy has been considerably more difficult than refractory epilepsy patients' access during the first year after FDA approval, we remain hopeful that the evidence regarding the unique long-term benefits offered by VNS Therapy to TRD patients and their payers, including the growing body of post- approval evidence, will ultimately prevail."
"We do not anticipate any meaningful sequential sales growth until such time as we obtain favorable coverage policies for VNS Therapy in TRD," commented Pamela B. Westbrook, vice president, finance and administration and chief financial officer, "and Cyberonics is not likely to return to corporate profitability (excluding non-cash stock options expenses required under FAS123R) until such time as TRD coverage policies facilitate sequential quarterly growth in U.S. Sales and the various stock option grant matters are behind us."
Proquest Identifier: 1171044761
* To access this Proquest article the user must create an account. |
| Contact us for assistance |
|
Research and Markets reports on Boston Scientific's merger with Guidant
Biotech Week January 31, 2007
Research and Markets announced the addition of Boston Scientific Medical Device Company Intelligence Report from Espicom Business Intelligence to their offering.
Boston Scientific, headquartered in Natick, Massachusetts, develops and manufactures products for use in minimally invasive procedures. The company's products are offered by three dedicated business groups; cardiovascular, endosurgery and neuromodulation.
The cardiovascular organization focuses on products and technologies for use in interventional cardiology, peripheral interventions, cardiac and vascular surgery, cardiac rhythm management (CRM), electrophysiology and neurovascular procedures. The key product in this area is the Taxus paclitaxel-eluting coronary stent system, which holds the second position in the global market for drug-eluting stents (DESs) after Johnson & Johnson's Cordis franchise's Cypher product. Taxus and Cypher are also the only two DESs available in the U.S., where Taxus has the leading market position.
The CRM and cardiac surgery operations were gained by Boston Scientific's much-publicized $27 billion merger with Guidant in April 2006, where it out-bid its main competitor, Johnson & Johnson that had previously entered into a merger agreement with Guidant.
In order to gain antitrust approval for the transaction, Guidant's vascular intervention and endovascular businesses were sold to Abbott, with both Boston Scientific and Abbott sharing rights to Guidant's Xience V DES program. As a result, Boston Scientific is the only company with access to two DES platforms and two DES drugs. The company will market the Xience V product as the Promus DES and recently received the CE mark for the product.
The merger added implantable defibrillator systems, including implantable cardiac resynchronization therapy defibrillators, as well as pacemakers and cardiac surgery products, to the Boston Scientific portfolio. However, Guidant's CRM business has faced problems since the beginning of 2005, when it undertook the withdrawal of around 200,000 products.
While it seemed these recalls would enable Guidant to rectify any issues before it merged with Boston Scientific, the problems continued, and Boston Scientific issued a further recall of products affecting over 27,000 patients in June 2006. These recalls have affected the market's confidence in Guidant's CRM products and have led to the filing of several lawsuits.
The transaction also came at a cost to Boston Scientific, with the company assuming a large amount to debt and giving equity to Abbott, as well as having to pay $705 million to J & J as a result of its Guidant merger termination. In addition, J & J has recently filed a lawsuit against Guidant, Boston Scientific and Abbott related to the merger, seeking damages of at least $5.5 billion.
Medical Device Company Intelligence Reports provide a full review of the company's activities, from its origins to its latest corporate activity, including mergers and acquisitions, agreements, divestitures, major purchasing contracts and litigation.
* To access this Lexis-Nexis article the user must create an account. |
| Contact us for assistance |
|
Reports from Medtronic detail the recent activities
Pharma Investments, Ventures & Law Weekly January 21, 2007
This trend article is an immediate alert from NewsRx to identify the most recent news developments at Medtronic.
Report 1: Medtronic, Inc. (MDT), announced the U.S. market launch of RestoreAdvanced and PrimeAdvanced, two new neurostimulation systems for the treatment of chronic pain. Introduction of these new systems extends Medtronic's market leadership in implantable neuromodulation devices.
The RestoreAdvanced device is based on Medtronic's Restore neurostimulator platform. Introduced in April 2005, the Restore neurostimulator emerged as the most powerful and longest-lasting rechargeable device of its kind approved by the U.S. Food and Drug Administration (FDA). The PrimeAdvanced device is based on Medtronic's Restorerime neurostimulator, a nonrechargeable device introduced earlier this year that offers the same coverage, customization, and therapy options of the Restore neurostimulator.
Report 2: Medtronic, Inc. (MDT) announced introduction of the Medtronic Octopus evolution tissue stabilizer, the latest in a 10-year series of cardiac surgery instruments.
The Octopus evolution tissue stabilizer is used in beating-heart surgery, with suction pods holding the surface tissue of the heart stable while a transplanted vessel is attached around blockages in the coronary arteries. Teamed with the Medtronic Starfish or urchin heart positioner, the Octopus evolution provides a technology to allow "off-pump" or OPCAB surgery on the beating heart. Off-pump surgery has become an attractive alternative to the traditional heart-lung machine, which is used to pump and oxygenate the patient's blood if the heart must be stopped for repairs.
Off-pump procedures have reached parity in safety and effectiveness with the conventional "arrested heart" technique and may be better in some cases for some patients, according to a statement last December by the International Society of Minimally Invasive Cardiothoracic Surgery. The statement, authored by 12 heart surgeons, was made after an analysis of worldwide published clinical evidence.
The surgeons found that beating-heart surgery should be considered a safe alternative to conventional bypass surgery with similar or reduced risk of mortality at 30 days with mixed-risk patients. The procedure is recommended in certain patient populations to reduce post-surgical problems such as stroke, heart attack, atrial fibrillation, and renal failure, which are less likely to occur when grafting is done as the heart continues to beat.
Beating-heart surgery is recommended to reduce the length of stay in the intensive care unit and in the hospital and should be considered for use on high-risk patients.
Report 3: In coordination with Cardiostim 2006, the 15th World Congress in Cardiac Electrophysiology and Cardiac Techniques, Medtronic, Inc., (MDT) announced European approval and market availability of the Concerto/Virtuoso line of implantable devices, which includes the Concerto cardiac resynchronisation therapy-defibrillator (CRT-D) and Virtuoso single- and dual-chamber implantable cardioverter-defibrillators (ICDs).
These are Medtronic's first cardiac rhythm disease management devices with wireless telemetry, enabling communication remotely between the implanted device and programmers in a clinician's office and at implant, or between the device and a patient home monitor.
Representing a new way to monitor patient health and disease progression, these devices allow heart patients to automatically receive visual notification on a home monitor called the PatientLook indicator when their device detects an alert, such as atrial fibrillation, thoracic fluid accumulation, or a device performance issue. If the PatientLook indicator notes an alert condition, patients are instructed to call their physician with this important health status information. In addition, patients may also manually initiate a self-check to view the status of their condition, and get visual notification of their alert status.
* To access this Lexis-Nexis article the user must create an account. |
| Contact us for assistance |
|
Medium-term experience of sacral neuromodulation by tined lead implantation.
BJU Int. 2007 Jan;99(1):107-10. Epub 2006 Sep 6.
Van Voskuilen AC, Oerlemans DJ, Weil EH, van den Hombergh U, van Kerrebroeck PE.
Department of Urology, Academisch Ziekenhuis Maastricht, Maastricht, the Netherlands and Medtronic Europe S.A., Tolochenaz, Switzerland.
OBJECTIVE: To describe patient selection for sacral neuromodulation, also known as Interstim therapy, and the results of tined-lead implantation in the medium term. PATIENTS AND METHODS: In all, 49 patients, 39 with refractory overactive bladder symptoms and 10 with urinary retention, were implanted with the tined lead under local anaesthesia. The mean (sd) test period was 12.4 (5.8) days. Patients were implanted when they had a > or = 50% improvement in voiding diary variables during the test period. The mean follow-up for implanted patients was 15.5 (7.9) months. Changes in voiding variables were compared using a t-test. RESULTS: Ten patients had a one-stage and 39 a two-stage implant; of the latter group, 31 (80%) had a positive response and eight (21%) did not. In all, 31 patients were included in the follow-up. At the last follow-up, 28 (90%) patients had a >50% improvement in diary variables and three (10%) did not. In 21 patients with urgency symptoms the mean (sd) number of voids decreased from 11.7 (8.9)/day at baseline to 7.3 (3.4)/day (P = 0.1); the voided volume increased from 160.2 (70.7) mL to 231.1 (119.5) mL (P = 0.001); and the number of leakages decreased from 9.5 (8.7) to 3.3 (2.2)/day (P = 0.17). In the 10 patients with retention, the number of catheterizations decreased from 5.44 (1.6)/day with a volume of 297.6 (76.8) mL, to 1.2 (1.7)/day and 111.6 (158.1) mL; the mean number of voids increased from 3.7 (3.8)/day with a volume of 123.3 (141.7) mL, to 4.2 (2.4)/day and 248.3 (146.0)mL. There were no significant differences in the variables in the patients with retention. Seven patients had an adverse event. There was one incomplete electrode migration that was treated conservatively. CONCLUSION: This new minimally invasive approach gives positive results in the medium term. Two-stage testing with the tined lead seems more reliable than the classic percutaneous nerve evaluation. The lead anchoring method seems sufficient for fixing the electrode in the medium term.
PreMedline Identifier: 16956350
***To access this PubMed use the PreMedline Identifier in the PubMed search field. |
| Contact us for assistance |
|
Spontaneous extrusion of sacral nerve implant secondary to massive weight loss.
Int Urogynecol J Pelvic Floor Dysfunct. 2007 Jan;18(1):105-107. Epub 2006 Apr 11.
Nold CJ, McLennan MT.
St. Louis University Department of Obstetrics, Gynecology and Women's Health, Division of Urogynecology, St. Louis University School of Medicine, 6420 Clayton Rd, Suite 290, St. Louis, MO, 63117, USA, mclennam@slucare1.sluh.edu.
Sacral neuromodulation (Interstim, Medtronic, Minneapolis, Minnesota) is a recognized treatment for refractory urgency, frequency, and urge incontinence. Revision rates range from 10-33% mainly for pain over the implantable pulse generator site (IPG) or lead migration [Hassouna et al. J Urol 163:1849-1854, 2000; Schmidt et al. J Urol 162:352-357, 1999; Spinelli et al. J Urol 166:541-545, 2001; Swinn et al. Eur Urol 38:439-443, 2000; Weil et al. Eur Urol 37:161-171, 2000; Evaraert et al. Int Urogynecol J Pelvic Floor Dysfunct 11:231-236, 2000]. We report a case of spontaneous extrusion of the IPG through the subcutaneous fat and skin secondary to marked weight loss after gastric bypass surgery. Continued weight loss resulted in multiple surgical interventions and eventual removal of the device.
PreMedline Identifier: 16607482
***To access this PubMed use the PreMedline Identifier in the PubMed search field. |
| Contact us for assistance |
|
| |
Please click here if you wish to return to the Table of Contents listing the most recent abstract database additions.
If you wish to know more about our MedIntelliBase Custom Email Alert service, please complete our request form or contact us directly for assistance. Our contact information is noted below.
Thank you for your interest in learning what our services can do to empower you -
The Next Phase® Inc. - Medical Technology Consultancy & Publishing
Redmond, WA, USA
Website - www.MedIntelliBase.com
|
|
