• AGA Medical (2)
  • Amplatzer Septal Occluder
  • Amplatzer PFO Occluder
• Aporo Biomedical/mNEMOSCIENCE
  • BIO-SMP Closure Device
• Cardia
  • Intrasept PFO Closure System
  • Intrasept ASD Closure System
• NMT Medical (1)
  • STARFlex
  • CardioSEAL
  • BioSTAR
• Occlutech
  • Figulla N
• St Jude Medical (2)
  • Premere PFO Closure System
• Swissimplant
  • Solysafe
• W. L. Gore (2)
  • Helex
• Atrial Septal Defect (ASD) (2)
  • NMT Medical
  • STARFlex
  • CardioSEAL
  • BioSTAR
  • AGA Medical
  • Amplatzer
  • Amplatzer Septal Occluder (1)
  • Cardia
  • Intrasept
  • St Jude Medical
  • Premere PFO Closure System
  • Closure (1)
  • Helex
• Left Atrial Appendage
  • AGA Medical
  • Amplatzer Vascular Plug
  • Aritech
  • Watchman Device
  • Closure
• Patent Foramen Ovale (PFO)
  • NMT Medical
  • STARFlex
  • BioSTAR
  • CardioSEAL
  • AGA Medical
  • Amplatzer (1)
  • Amplatzer Septal Occluder
  • Amplatzer PFO Occluder
  • Cardia
  • Intrasept
  • St Jude Medical
  • Premere PFO Closure System
  • Closure (5)
  • Figulla N
• Stroke & Migraine (1)
• Ventricular Septal Defect (VSD) (2)
  • NMT Medical
  • STARFlex
  • CardioSEAL
  • AGA Medical
  • Amplatzer (1)
  • Amplatzer Septal Occluder
  • Amplatzer PFO Occluder
  • Cardia
  • Intrasept
  • Closure
• Cardiac
  • Conference* (2)
  • Meeting*
  • Symposium*

(A small sampling of selected results from February 26, 2008  to March 03, 2008 MIB Abstract Alert search)

Go to Archive

Patents; AGA Medical Corporation Responds to Occlutech Statement on the Status of the Ongoing Patent Litigation in Europe

Lead Author: [none given]

Medical Patent Week., 2008-03-02, pg. 26

AGA Medical issued the following response to a press release distributed on February 7, 2008 regarding a purported victory Occlutech GmbH had achieved in the AIPPI in AGA's patent dispute with Occlutech. The release suggested that a proceeding of some sort was conducted before the AIPPI and that organization agreed with the Occlutech position. That suggestion is false and misleading. AGA has not been involved in any proceedings with Occlutech in which AIPPI has been involved. AIPPI has not contacted AGA for its comments on any matter.

According to its charter, AIPPI is characterized as a trade and professional association and not an adjudicatory body. AIPPI does not seem to engage in any arbitration work. AIPPI is not the "European International Association for the Protection of Intellectual Property" as Occlutech claims, but is simply the International Association for the Protection of Intellectual Property, having no connection with any European governmental entity.

The facts are as follows: after being found to be an infringer of AGA's patent in Germany, Occlutech has made two attempts to stay enforcement in Germany, both of which were unsuccessful. They made an unsuccessful attempt to obtain a ruling of non-infringement/ invalidity in Italy that did not succeed. In addition, Occlutech has been found guilty of violating the Court order on infringement in Germany and was fined by the court. The injunction of the German court remains in place.

Additionally, AGA Medical is exploring remedies under German law that might be available to prevent such misrepresentations from continuing.

MIB Abstract ID Number: 14615

Proquest Identifier: 1432701281

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AGA MEDICAL GETS CE MARK FOR AMPLATZER DUCT OCCLUDER II

Lead Author: [none given]

Biotech Equipment Update., 2008-03-01, Vol. 16, Iss. 3

AGA Medical Corporation, Minneapolis, has received European CE Mark approval for the AMPLATZER(R) Duct Occluder II ("ADO II"). AGA also announced the immediate availability and launch of the device in Europe. The ADO II expands the AGA family of occlusion devices designed to occlude or close a patent ductus arteriosus ("PDA"), a type of congenital heart defect that occurs when a blood vessel called the ductus arteriosus fails to close after birth, as it normally should.

"We believe the new ADO II represents a development milestone for AGA Medical and demonstrates the success of our product development programs," said Franck Gougeon, president and CEO of AGA. "It is our first approved occlusion device designed to treat structural heart defects that does not include fabric to assist in rapid occlusion. This expands the type of ducts that can be closed by our family of PDA devices."

The ADO II is a self-expanding nitinol mesh device and is designed to be introduced in a minimally invasive fashion through a catheter. The device has two retention disks positioned on either side of the duct and connected by a waist. The ADO II is designed with a screw mechanism for attachment to the deployment cable that allows the device to be withdrawn and repositioned, if necessary, prior to release from the cable.

The device treats a PDA. The ductus arteriosus is an open channel in every fetus that allows blood to bypass the lungs, which are not used until the baby takes its first breath after birth. Shortly after the baby's first breath, the ductus arteriosus should close permanently. If it does not close, it is known as a PDA. This condition can cause symptoms such as fatigue, difficulty or rapid breathing, failure to grow normally, or chronic respiratory infections such as colds and pneumonia, or endocarditis.

"The ADO II greatly improves treatment options for babies and young children because it can be used with very small diameter catheters," said Mr. Gougeon.

The original Amplatzer Duct Occluder received the CE Mark in 1998 and was approved by the U.S. Food and Drug Administration ("FDA") in 2003. It is currently under review by Japanese regulatory authorities. AGA shipped more than 51,000 Amplatzer Duct Occluders in the United States, Europe and other international markets as of December 31, 2007. AGA has applied with the FDA to conduct a clinical trial in the U.S. to support approval for the ADO II.

ABOUT AGA MEDICAL: AGA Medical Corporation, based in Plymouth, Minnesota (just outside Minneapolis), is a leader in developing interventional devices to treat structural heart defects. As a result of the many contributions and creative genius of Dr. Kurt Amplatz, AGA develops and commercializes a series of devices that have revolutionized the treatment of the most common congenital "holes in the heart" such as atrial septal and patent foramen ovale defects. The company is expanding into new areas such as the minimally invasive repair of vascular abnormalities. More than 770 articles have been published in medical publications that support the benefits of AGA devices, including improved patient outcomes, reduced length of stay and accelerated recovery times for the patient. AGA Medical devices have received regulatory approval and are marketed in 101 countries with more than 278,000 devices shipped to date.

MIB Abstract ID Number: 14616

Proquest Identifier: 1430084421

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NMT Medical to Present at Cowen and Company's 28th Annual Health Care Conference

Lead Author: [none given]

Business Wire. New York:, 2008-03-03

NMT Medical, Inc. (Nasdaq: NMTI) today announced that NMT's executive management will be presenting at Cowen and Company's 28th Annual Health Care Conference. The Conference will be held March 17 to 20, 2008 at The Boston Marriott Copley Place, Boston, Massachusetts.

The Company's presentation will be broadcast live over the Internet on Monday, March 17, 2008 at 1:45 p.m. (ET). Presenting for NMT will be President and Chief Executive Officer John E. Ahern. He will be accompanied by Executive Vice President and Chief Financial Officer Richard E. Davis.

Individuals who are interested in listening to the webcast should log on to the "Investor Relations" section of NMT Medical's website at www.nmtmedical.com. For those unable to listen to the live broadcast, a replay of the presentation will be available on the Company's website following the event.

About NMT Medical, Inc.

NMT Medical is an advanced medical technology company that designs, develops, manufactures and markets proprietary implant technologies that allow interventional cardiologists to treat structural heart disease through minimally invasive, catheter-based procedures. NMT is currently investigating the potential connection between a common heart defect that allows a right to left shunt or flow of blood through a defect like a patent foramen ovale (PFO) and brain attacks such as embolic stroke, transient ischemic attacks (TIAs) and migraine headaches. A common right to left shunt can allow venous blood, unfiltered and unmanaged by the lungs, to enter the arterial circulation of the brain, possibly triggering a cerebral event or brain attack. More than 27,000 PFOs have been treated globally with NMT's minimally invasive, catheter-based implant technology.

Stroke is the third leading cause of death in the United States and the leading cause of disability in adults. Each year, 750,000 Americans suffer a new or recurrent stroke and an additional 500,000 Americans experience a TIA. The prevalence of migraines in the United States is about 10%. Of the 28 million migraine sufferers in America, those who experience aura and have a PFO may represent a three million patient subset.

For more information about NMT Medical, please visit www.nmtmedical.com.

MIB Abstract ID Number: 14617

Proquest Identifier: 1438656641

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Failure of Guideline-based Anticoagulation in a Patient with Mitral Prosthetic Valve and Recurrent Thromboembolism.

Lead Author: Mutlu H

Additional Authors: Yerlioglu ME, Levy WK.

J Am Soc Echocardiogr., 2008-03-01, 21(3):296.e1-3. Epub 2007 Jul 27.

Department of Medicine, Berkshire Medical Center, Pittsfield, Massachusetts.

Prosthetic valve (PV)-related thromboembolism is a rare but serious complication of implanted mechanical valves. There is not a design that has yet achieved mechanical perfection; therefore, using these mechanical valves is not free of mortality and morbidity. Some of the complications of using such valves include PV thrombosis, systemic embolization, bleeding, endocarditis, perivalvular leak, and structural valve failure. These valves are thrombogenic, and their use requires anticoagulation postoperatively to prevent systemic embolization and PV thrombosis. This intervention also carries the risk of bleeding, which can be detrimental for a subset of patients, especially elderly, pregnant, and those with other systemic comorbidities. In this case we present a patient with recurrent thromboembolic events and a nonobstructing St. Jude mitral PV thrombosis despite vigorous anticoagulation with Coumadin (Bristol-Myers Squibb Co., Princeton, NJ) and aspirin.

MIB Abstract ID Number: 14618

PreMedline Identifier: 17681732

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St. Jude Medical Named FORTUNE Magazine's Most Admired Medical and Other Precision Equipment Company for Second Consecutive Year

Lead Author: [none given]

Business Wire. New York:, 2008-03-03

St. Jude Medical, Inc. (NYSE:STJ) today announced that FORTUNE Magazine has named it one of "America's Most Admired Companies" for 2008. St. Jude Medical ranked No. 1 in the Medical and Other Precision Equipment category for the second year in a row.

St. Jude Medical has been named to FORTUNE's Most Admired Companies list in each of the last four years.

"We are honored to again be recognized among America's most admired companies by one of the world's most admired publications," said Daniel J. Starks, chairman, president and CEO of St. Jude Medical. "Our designation as the number one most admired medical equipment company is a testament to the dedication of our 12,000 St. Jude Medical employees who make life better for cardiac, neurological and chronic pain patients worldwide."

FORTUNE surveyed more than 15,000 top executives, directors and members of the financial community to develop the rankings. The magazine uses a rigorous assessment to determine a company's overall reputation. St. Jude Medical ranked either first or second in the medical equipment category for each of the magazine's eight areas of assessment:

-- Innovation

-- People management

-- Use of corporate assets

-- Social responsibility

-- Quality of management

-- Financial soundness

-- Long-term investment

-- Quality of products/services

The "Most Admired Companies" list is included in the March 17 issue, available on newsstands March 10 and available online.

About St. Jude Medical

St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The Company has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 12,000 people worldwide. For more information, please visit www.sjm.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings, and market shares. The statements made by the Company are based upon management's current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company's control and the risk factors and other cautionary statements described in the Company's filings with the SEC, including those described in the Company's Annual Report on Form 10-K filed on February 27, 2008 (see Item 1A on pages 13-20, and page 20 of Exhibit 13 to the Company's Form 10-K). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

St. Jude Medical, Inc.

Investor Relations

Angela Craig, 651-481-7789

or

Media Relations

Kathleen Janasz, 651-415-7042

MIB Abstract ID Number: 14619

Proquest Identifier: 1438664751

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Impact of endograft design and product line on the device cost of endovascular aneurysm repair.

Lead Author: Feezor RJ

Additional Authors: Huber TS, Berceli SA, Nelson PR, Seeger JM, Lee WA.

J Vasc Surg., 2008-03-01, 47(3):499-503.

Division of Vascular Surgery and Endovascular Therapy, University of Florida College of Medicine, Gainesville, Fla.

OBJECTIVE: Device cost is a substantial component of the overall cost of endovascular abdominal aneurysm repair (EVAR), and the four commercially available devices differ significantly in the cost of their basic configuration. This study examined the impact of three different endografts and their product lines on the overall cost of repair. METHODS: Implant records of 467 EVAR procedures performed during 2000 through 2006 were reviewed. The three devices used were the AneuRx in 178 (38.1%; Medtronic, Santa Rosa, Ca), the Excluder in 123 (26.3%; W. L. Gore & Associates, Flagstaff, Ariz), and the Zenith in 166 (35.5%; the Cook Zenith (Bloomington, Ind). The Powerlink device (Endologix, Irvine, Calif) was not studied. The specific device implanted was determined by its commercial availability at the time of repair, patient anatomy, and surgeon preference. Retail list prices were used for all calculations, and only devices used during the original repair were used for analysis. RESULTS: The device cost of the most basic configuration for repair (ie, 2 pieces for AneuRx and Excluder, 3 pieces for Zenith) differed by $3022 between the most expensive (Zenith) to the least expensive (AneuRx). However, the AneuRx system required the most number of extensions (1.90 +/- 1.25 per case; range, 0-7), whereas the Zenith required the fewest (0.21 +/- 0.51 per case; range, 0-3). When the costs of the extensions were added, the overall mean device costs per case were similar. CONCLUSION: The initial cost advantage of the AneuRx and Excluder endograft systems were offset by the more frequent need for proximal and distal extensions. The minimum device cost of a basic repair should not factor into the decision to select one specific device over another because additional devices may be required depending on the design and construction of the endograft system and the accuracy and reliability of their deployment mechanisms.

MIB Abstract ID Number: 14621

PreMedline Identifier: 18295102

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First Patient Enrolled in Laser Ablation Study

Lead Author: [none given]

FDAnews Device Daily Bulletin, 2008-02-26

W.L. Gore & Associates and Spectranetics have begun the VIVA II: SALVAGE trial.

The trial will evaluate the Gore Viabahn endoprosthesis and Spectranetics' Turbo-Booster and Turbo elite laser catheter with the CVX-300 Excimer laser system for the treatment of peripheral vascular disease in the superficial femoral artery.

The study will evaluate the effectiveness of the combination as a treatment for up to 100 patients with chronic lower-limb ischemia associated with femoro-popliteal in-stent restenosis -- a renarrowing or blockage of an artery at a treatment site, Spectranetics said.

MIB Abstract ID Number: 14622

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Incidence, timing, and predictive factors of new-onset migraine headache attack after transcatheter closure of atrial septal defect or patent foramen ovale.

Lead Author: Rodés-Cabau J

Additional Authors: Mineau S, Marrero A, Houde C, Mackey A, Côté JM, Chetaille P, Delisle G, Bertrand OF, Rivest D.

Am J Cardiol., 2008-03-01, 101(5):688-92. Epub 2007 Dec 21.

Quebec Heart Institute, Laval Hospital, Quebec, Canada.

The objectives of this study were to evaluate the incidence, predictive factors, and duration of migraine headache attack (MHA) after transcatheter atrial septal defect (ASD) or patent foramen ovale (PFO) closure. A total of 260 consecutive patients who underwent ASD or PFO closure in our center answered a structured headache questionnaire focused in 3 period times, including (1) at baseline (just before closure), (2) within the 3 months after ASD-PFO closure, and (3) at the last (median 27 months, range 6 to 80 months) follow-up. All questionnaires were evaluated by a neurologist who established the diagnosis of MHA with or without aura, according to International Headache Society criteria. The Amplatzer ASD or PFO device was used in 95% of the patients, and aspirin, for at least 6 months, was the antithrombotic treatment in 91% of the cases. A total of 185 patients (71%) had no history of MHA before ASD-PFO closure, and these constituted the study population (mean age 39 +/- 21 years). MHA occurred in 13 patients (7%) after ASD-PFO closure, with aura in 9 of them. MHA appeared after a median of 10 days (range 0.3 to 30 days) after the procedure and were still present at the last follow-up (23 +/- 17 months) in 9 patients (69%). The median number of MHA within the 3 months after the procedure was 4 per month (interquartile range 1 to 23), and decreased to 1 per month (interquartile range 0.3 to 1) at the latest follow-up (p = 0.03). Compared with the patients who did not develop MHA, patients with MHA after ASD-PFO closure were younger (26 +/- 16 vs 39 +/- 21 years; p = 0.02) and were more likely to have undergone ASD closure (100% vs 58%; p = 0.001). In the multivariate analysis, ASD closure was the only predictor of MHA occurrence after the procedure (odds ratio 7.7; 95% confidence interval 1.5 to 22; p = 0.01). In conclusion, MHA, mostly with aura, occurred in 7% of patients after transcatheter ASD-PFO closure and persisted in most of them after a mean follow-up of 2 years. ASD closure was the only independent predictor of MHA occurrence after the procedure. These results suggest that mechanisms other than device composition are involved in the occurrence of MHA in these cases.

MIB Abstract ID Number: 14626

PreMedline Identifier: 18308022

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Long-term impact of transcatheter atrial septal defect closure in adults on cardiac function and exercise capacity.

Lead Author: Giardini A

Additional Authors: Donti A, Specchia S, Formigari R, Oppido G, Picchio FM.

Int J Cardiol., 2008-02-29, 124(2):179-82. Epub 2007 Mar 30.

Pediatric Cardiology and Adult Congenital Unit, University of Bologna, Via Massarenti 9, 40138, Bologna, Italy. alessandro5574@iol.it

MIB Abstract ID Number: 14627

PreMedline Identifier: 17399817

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Embolization of an amplatzer atrial septal closure device to the pulmonary artery.

Lead Author: Chiappini B

Additional Authors: Gregorini R, Di Eusanio M, Ciocca M, Villani C, Minuti U, Giancola R, Prosperi F, Petrella L, Paparoni S, Mazzola A.

J Card Surg., 2008-03-01, 23(2):164-7.

Department of Cardiac surgery, "G.Mazzini" Hospital, Teramo, Italy.

A 44-year-old woman with a history of transient ischemic attack underwent closure of atrial septal defect with a 26 mm Amplatzer device. The device was released without residual shunt or impingement on intracardiac structures. Within seconds, the transesophageal echocardiography showed the initial dislodgement of the device from the atrial septum and its consequent slipping back into the right atrium close to the tricuspid valve. Soon after the device disappeared from the right atrium and it could be founded into the right ventricle under the tricuspid valve. The patient was transferred in the operating room for an emergency operation. The device could not be found in the right ventricle because its downstream migration. The Amplatzer septal occluder was identified by palpation into the pulmonary artery trunk: it was retrieved from the right ventricle through the pulmonary valve and the atrial septal defect was closed by running suture.

MIB Abstract ID Number: 14623

PreMedline Identifier: 18304135

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Predictors of Atrial Arrhythmias After Device Closure of Secundum Type Atrial Septal Defects in Adults

Lead Author: Candice K Silversides

Additional Authors: Kym Haberer, Samuel C Siu, Gary D Webb, Lee N Benson, Peter R McLaughlin, Louise Harris

The American Journal of Cardiology. , 2008-03-01, Vol. 101, Iss. 5; pg. 683

Atrial tachyarrhythmias (ATs) contribute substantially to morbidity in adult patients with secundum atrial septal defects (ASDs). The purpose of this study was to prospectively determine the incidence of AT in adults with an ASD and identify predictors of AT occurrence after closure. This was a prospective study of 200 adult patients undergoing closure of a secundum ASD. Arrhythmic events were defined as sustained or symptomatic AT requiring treatment. Twenty percent of patients (mean age 50 ± 17 years; 26% men) referred for ASD closure had a history of AT. Early follow-up was available for 90% of patients, and the prevalence of AT was 17%. Of 171 patients with late follow-up (mean 1.9 ± 0.9 years), data were available for 90%. AT was detected in 16% of these patients. Closure resulted in alleviation of symptoms (p <0.001), but symptoms alone did not identify patients at risk of recurrent AT. After closure of the ASD, the likelihood of remaining arrhythmia free was highest in patients without a history of AT (p = 0.001) and those <40 years at closure (p = 0.04). In conclusion, transcatheter ASD closure in patients without a history of arrhythmias and those <40 years of age conferred the highest likelihood of a patient remaining arrhythmia free in follow-up. An arrhythmia-specific treatment strategy should be considered for patients with documented established AT before ASD closure, in addition to shunt relief.

MIB Abstract ID Number: 14625

Proquest Identifier: 1436237431

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Transseptal puncture for catheter ablation of atrial fibrillation after device closure of patent foramen ovale.

Lead Author: Zaker-Shahrak R

Additional Authors: Jürg Fuhrer, Meier B.

Catheter Cardiovasc Interv., 2008-02-28, 71(4):551-552[Epub ahead of print]

Department of Cardiology, University Hospital, Bern, Switzerland.

The technique of transseptal puncture for catheter ablation of atrial fibrillation after percutaneous closure of a foramen ovale with the Amplatzer Occluder is demonstrated based on 2 representative cases. (c) 2008 Wiley-Liss, Inc.

MIB Abstract ID Number: 14628

PreMedline Identifier: 18307237

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Asymptomatic significant patent foramen ovale: Giving patent foramen ovale management back to the cardiologist.

Lead Author: Rigatelli G

Additional Authors: Cardaioli P, Chinaglia M.

Catheter Cardiovasc Interv., 2008-02-28, 71(4):573-577 [Epub ahead of print]

Cardiovascular Diagnosis and Endoluminal Interventions, Rovigo General Hospital, Rovigo, Italy.

Percutaneous closure of patent foramen ovale (PFO) is still a much debated issue. Although many questions remain open, patients are finding out about PFO management and are beginning to ask for the most rapid and complete solution to their potential problems in spite of the warnings from the medical profession about off-label indications for transcatheter closure. As a result, asymptomatic patients with PFO are coming into medical offices to be assured about stroke risk or treated for any degree of migraine. The cardiologist should be the preferred interlocutor in asymptomatic significant PFO: he is competent in assessing the associated anatomical and functional risk factors, and he is the only specialist who can evaluate on the basis of the anatomo-functional picture the potential risk of paradoxical embolism and discuss with patients eventual off-label indications to closure. (c) 2008 Wiley-Liss, Inc.

MIB Abstract ID Number: 14629

PreMedline Identifier: 18307240

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The parallel wire technique for septal defect closure.

Lead Author: Chiam PT

Additional Authors: Cohen HA, Ruiz CE.

Catheter Cardiovasc Interv., 2008-02-28, 71(4):564-567 [Epub ahead of print]

Department of Cardiac and Vascular Interventional Services, Lenox Hill Heart and Vascular Institute of New York.

Percutaneous closure of sedundum atrial septal defects (ASD) has been shown to be safe and effective. Usually crossing the defect is relatively straightforward. Occasionally, with fenestrated ASDs, trying to cross the defect(s) may be challenging. We report the use of a "paralle wire" (0.018 or 0.014 inch wire) technique to maintain access and be able to recross the same defect easily in case of misplacement until just before the device was secured and released. This technique could be used also as a "body wire" for large ASDs with deficient rims to reduce the incidence of device prolapse, and for patent foramen ovale and ventricular septal defect closures. This is a simple and easily reproducible method with the equipment readily available in virtually all catheterization laboratories. (c) 2008 Wiley-Liss, Inc. 

MIB Abstract ID Number: 14630

PreMedline Identifier: 18307233

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Migraine, stroke and patent foramen ovale: a dangerous trio?

Lead Author: Butera G

Additional Authors: Agostoni E, Biondi-Zoccai G, Bresolin N, Fumagalli L, Chessa M, Gallanti A, Scacciatela P, Carminati M.

J Cardiovasc Med (Hagerstown)., 2008-03-01, 9(3):233-238.

aDepartment of Paediatric Cardiology, Policlinico San Donato IRCCS, San Donato Milanese (MI), Italy bDepartment of Neurosciences, Manzoni Hospital, Lecco, Italy cDepartment of Neurology, Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, IRCCS, Mi

The relationship between migraine, stroke and patent foramen ovale (PFO) has been the subject of considerable research efforts. Indeed, a lot of interest has focused on the potential benefits of percutaneous PFO closure. The aim of this article is to review data from the currently available literature. A total of 10 relevant studies were found in the literature, for a total of 1038 patients undergoing percutaneous PFO closure after events of cryptogenic stroke. Thirty-eight percent of these patients suffered from migraine. Combining the results of the available studies, 72% of patients were cured or improved significantly. Analysing the results according to migraine type, 81% of patients with migraine with aura had complete resolution or significantly improved as compared to 72% of patients with migraine without aura. Several limitations and drawbacks exist, however, and they are extensively discussed in this paper.

MIB Abstract ID Number: 14631

PreMedline Identifier: 18301138

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Minimally invasive congenital cardiac surgery through right anterior minithoracotomy approach.

Lead Author: Mishaly D

Additional Authors: Ghosh P, Preisman S.

Ann Thorac Surg., 2008-03-01, 85(3):831-5.

Department of Pediatric Cardiac Surgery, Sheba Medical Center, Tel Hashomer, Israel. dmishaly@sheba.health.gov.il

BACKGROUND: Median sternotomy has been the conventional approach for correction of congenital cardiac defects despite poor cosmetic results at times. Right anterior minithoracotomy was, therefore, assessed as an alternative procedure with a better cosmetic outcome. METHODS: From October 2002 through February 2007, 75 patients underwent correction of congenital cardiac malformations with the use of cardiopulmonary bypass through right anterior minithoracotomy involving a short incision through the fifth intercostal space and the minimally invasive cannulation. Of them, 18 patients were infants, 42 were children, and 15 were adult. The average age was 9.26 +/- 14.1 years (range, 1.2 to 56). The average weight was 19.59 +/- 24.3 kg (range, 8.5 to 118 kg). The corrected defects included atrial septal defect type II, sinus venosus atrial septal defect with partial anomalous pulmonary venous drainage, atrial component of atrioventricular septal defect, perimembranous ventricular septal defects with patent foramen ovale, mitral valve repair (complex), repair of cleft mitral valve, cor triatum atrial septal defect, repair of double-chambered right ventricle and extraction of atrial septal defect closure device. Skin incisions were as long as 5 cm. RESULTS: There was no operative or late mortality or major morbidity. The mean cardiopulmonary bypass time was 58.67 +/- 35.11 minutes (range, 32 to 263). Sixty-five patients were extubated in the operating room; the remaining 10 patients were extubated within 4 hours. Cosmetic result was very satisfactory in all patients. Two adult patients complained of some right chest musculoskeletal discomfort. CONCLUSIONS: The right anterior minithoracotomy incision is a safe and effective alternative to a median sternotomy for correction of congenital heart defects. Cosmetic results are highly satisfactory.

MIB Abstract ID Number: 14632

PreMedline Identifier: 18291151

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Long-term results after fluoroscopy-guided closure of patent foramen ovale for secondary prevention of paradoxical embolism.

Lead Author: Wahl A

Additional Authors: Kunz M, Moschovitis A, Nageh T, Schwerzmann M, Seiler C, Mattle HP, Windecker S, Meier B.

Heart., 2008-03-01, 94(3):336-41. Epub 2007 Jul 16.

Cardiology Department, University Hospital Bern, Switzerland.

OBJECTIVES: To carry out long-term follow-up after percutaneous closure of patent foramen ovale (PFO) in patients with cryptogenic stroke. DESIGN: Prospective cohort study. SETTING: Single tertiary care centre. PARTICIPANTS: 525 consecutive patients (mean (SD) age 51 (12) years; 56% male). INTERVENTIONS: Percutaneous PFO closure without intraprocedural echocardiography. MAIN OUTCOME MEASURES: Freedom from recurrent embolic events. RESULTS: A mean (SD) of 1.7 (1.0) clinically apparent embolic events occurred for each patient, and 186 patients (35%) had >1 event. An atrial septal aneurysm was associated with the PFO in 161 patients (31%). All patients were followed up prospectively for up to 11 years. The implantation procedure failed in two patients (0.4%). There were 13 procedural complications (2.5%) without any long-term sequelae. Contrast transoesophageal echocardiography at 6 months showed complete closure in 86% of patients, and a minimal, moderate or large residual shunt in 9%, 3% and 2%, respectively. Patients with small occluders (<30 mm; n = 429) had fewer residual shunts (small 11% vs large 27%; p<0.001). During a mean (SD) follow-up of 2.9 (2.2) years (median 2.3 years; total 1534 patient-years), six ischaemic strokes, nine transient ischaemic attacks (TIAs) and two peripheral emboli occurred. Freedom from recurrent stroke, TIA, or peripheral embolism was 98% at 1 year, 97% at 2 years and 96% at 5 and 10 years, respectively. A residual shunt (hazard ratio = 3.4; 95% CI 1.3 to 9.2) was a risk factor for recurrence. CONCLUSIONS: This study attests to the long-term safety and efficacy of percutaneous PFO closure guided by fluoroscopy only for secondary prevention of paradoxical embolism in a large cohort of consecutive patients.

MIB Abstract ID Number: 14633

PreMedline Identifier: 17639093

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Asymptomatic significant patent foramen ovale: Giving patent foramen ovale management back to the cardiologist.

Lead Author: Rigatelli G

Additional Authors: Cardaioli P, Chinaglia M.

Catheter Cardiovasc Interv., 2008-02-28, 71(4):573-577 [Epub ahead of print]

Cardiovascular Diagnosis and Endoluminal Interventions, Rovigo General Hospital, Rovigo, Italy.

Percutaneous closure of patent foramen ovale (PFO) is still a much debated issue. Although many questions remain open, patients are finding out about PFO management and are beginning to ask for the most rapid and complete solution to their potential problems in spite of the warnings from the medical profession about off-label indications for transcatheter closure. As a result, asymptomatic patients with PFO are coming into medical offices to be assured about stroke risk or treated for any degree of migraine. The cardiologist should be the preferred interlocutor in asymptomatic significant PFO: he is competent in assessing the associated anatomical and functional risk factors, and he is the only specialist who can evaluate on the basis of the anatomo-functional picture the potential risk of paradoxical embolism and discuss with patients eventual off-label indications to closure. (c) 2008 Wiley-Liss, Inc.

MIB Abstract ID Number: 14634

PreMedline Identifier: 18307240

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Initial clinical manifestations and mid- and long-term results after surgical repair of double-chambered right ventricle in children and adults.

Lead Author: Telagh R

Additional Authors: Alexi-Meskishvili V, Hetzer R, Lange PE, Berger F, Abdul-Khaliq H.

Cardiol Young. , 2008-03-03, 1-7 [Epub ahead of print]

Department of Congenital Heart Disease, Deutsches Herzzentrum Berlin, Berlin, Germany.

MIB Abstract ID Number: 14636

PreMedline Identifier: 18312713

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The Ross procedure in infants and young children.

Lead Author: Kadner A

Additional Authors: Raisky O, Degandt A, Tamisier D, Bonnet D, Sidi D, Vouhé PR.

Ann Thorac Surg., 2008-03-01, 85(3):803-8.

Department of Cardiovascular Surgery, University Hospital, Berne, Switzerland. a.kadner@web.de

BACKGROUND: This study reviews our experience with the Ross procedure in infants and young children. METHODS: From September 1993 to September 2004, 52 children less than 15 years of age underwent a Ross procedure. The patients ranged in age from 4 days to 15 years old (median, 5 years). Fifteen patients (29%) were less than 2 years of age. The predominant indication for the Ross procedure was aortic stenosis. Sixteen patients underwent a Ross-Konno procedure for severe left ventricular outflow tract obstruction. Thirty-four patients had 48 previous interventions. Preoperatively, 6 patients showed severe left ventricular dysfunction, and 2 of the patients required ventilation and inotropic support. Concomitant procedures were performed in 8 patients. Three patients had a mitral valve replacement, 2 patients had a ventricular septal defect closure and an aortic arch reconstruction, 2 patients had aortic arch reconstructions, and 1 patient had resection of a coarctation and a ventricular septal defect closure. RESULTS: Patients were followed up for a median of 43 months (range, 1 to 130). Overall survival was 85% +/- 5% at 1 and 82% +/- 5% at 2, 5, and 10 years. Hospital mortality was 5 of 52 patients (9.6%). All deaths occurred in neonates or infants less than 2 months of age, who needed urgent surgery. Three patients died late of noncardiac causes. At last follow-up, all patients were classified in New York Heart Association functional class I or II. No patient had endocarditis of the autograft or the right ventricular outflow tract replacement. During the follow-up, no event of thrombembolism was observed. No patient required the insertion of a permanent pacemaker. Overall freedom from reoperation is 57% +/- 15% at 10 years. One patient required the replacement of the autograft at 6 months postoperatively. The development of mild aortic insufficiency was observed in 24 patients, and moderate aortic insufficiency in 1 patient during follow-up. Freedom from reoperation for the right ventricular outflow tract replacement is 60% +/- 15% at 10 years. CONCLUSIONS: The Ross procedure represents an attractive approach to aortic valve disease in young children. However, a high early mortality rate has to be considered when performing this procedure in neonates or infants who present in critical preoperative condition.

MIB Abstract ID Number: 14637

PreMedline Identifier: 18291145

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Transcatheter closure of a residual shunt after surgical repair of traumatic ventricular septal defect.

Lead Author: Lee JH

Additional Authors: Park JH, Choi SW, Jeong JO, Gil HR, Yu JH, Seong IW.

Int J Cardiol., 2008-02-29, 124(2):e34-6. Epub 2007 Mar 23.

We report a patient with a significant residual left-to-right shunt who underwent surgical repair for traumatic VSD. This 13-year-old boy was stabbed with a pair of scissors through his heart. After initial life-saving surgery with lacerated left ventricular wall repair and VSD closure, residual VSD was noted. Six months later, we performed a successful transcatheter closure of the residual VSD with an Amplatzer muscular VSD occluder.

MIB Abstract ID Number: 14635

PreMedline Identifier: 17360060

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SoCalBio HR Conference to Examine Greater Los Angeles Region's Biomed and Biotech Employment Trends, Challenges and Opportunities

Lead Author: [none given]

Business Wire. New York:, 2008-02-27

Workforce issues affecting the Greater Los Angeles medical device and biotechnology sector will be the focus of the Second Annual Human Resources Conference hosted by the Southern California Biomedical Council (SoCalBio or SCBC). This event will be held Friday, February 29th at the Wilshire Grand Hotel in downtown Los Angeles: http://www.socalbio.org/SoCalBio_HR_Conference/HR_Conference_Home.htm

While the six-county region of Greater Los Angeles has emerged as one of the leading center for biomed and biotech innovation, the region is at a crossroads in terms of its ability to remain competitive and retain the more than 85,000 high-wage jobs employed by local firms.

SoCalBio's day-long HR Conference is the only event of its kind dedicated to addressing regional strategies for nurturing biomed/biotech human capital and employment needs. More than 25 keynote speakers and panelists - including representatives of the FDA, local companies such as Allergan, Baxter Bioscience, Beckman Coulter, MannKind Corp., St. Jude Medical and Xencor, HR and workforce development professionals, employment lawyers, and educators -- will tackle a range of issues of special relevance to small and mid-size companies.

Organized by SoCalBio's Workforce Development Committee, the conference will provide a forum for information sharing among HR executives and service providers, educators and policy makers. Topics will include new educational and training initiatives, regulatory compliance, legal liability, immigration policy and the role of HR in retaining top talent and creating a competitive edge.

"This event is unique in that it is the only HR conference in California sponsored by a regional life science trade association to systematically address strategies for nurturing the workforce of the future," said Diane Palumbo, corporate vice president at MannKind Corporation and chair of SoCalBio's Workforce Development Committee. "There's no doubt that the life science industry in California, and the Greater Los Angeles region in particular, will be a function of the availability of a skilled workforce."

SoCalBio President & CEO Ahmed Enany added, "Our goal is not just to exchange views on what's new in life-science HR, but to critically examine best practices and strategies to forge the public-private partnerships necessary to meet the workforce needs of local medical device and biotech companies."

The Southern California Biomedical Council would like to thank the following companies and organizations for sponsoring the HR Conference:

-- ABD Insurance (www.abdi.com)

-- Bench International (www.benchinternational.com)

-- California Community Colleges Economic & Workforce Development Program (www.cccbiotech.org)

-- CSUPERB (www.csuchico.edu/csuperb)

-- Davis Wright Termaine LLP (www.dwt.com)

-- MannKind Corporation (www.mannkindcorp.com)

-- Med Exec International (www.medexecintl.com)

-- Medical Device Training Initiative of Orange County (www.mdtioc.org)

-- Morgan, Lewis & Bockius LLP (www.morganlewis.com)

-- Parkway Clinical Laboratories (www.parkwayclinical.com)

-- Remedy Compensation Consulting (www.remedycomp.com)

-- Spencer Stuart (www.spencerstuart.com)

More information about SoCalBio's Second Annual HR Conference is available at http://www.socalbio.org/SoCalBio_HR_Conference/HR_Conference_Home.htm.

About the Southern California Biomedical Council (SoCalBio)

The Southern California Biomedical Council is a nonprofit, member-supported trade association that promotes and supports life-science research, development, manufacturing, job creation and overall economic growth in the six counties of the Greater Los Angeles region (Los Angeles, Orange, Ventura, Santa Barbara, Riverside and San Bernardino Counties).

The Council's programs help local firms gain access to capital, potential partners and business support services. The annual SoCalBio Investor Conference has grown to become the region's premiere showcase for emerging life-science companies and technologies. SoCalBio also promotes technology transfer and workforce training, and informs policy makers and the public at-large about the benefits of the region's life-science industry.

SoCalBio is open to membership by firms and organizations engaged in life-science technology development and commercialization. More information is available at www.socalbio.org.

MIB Abstract ID Number: 14620

Proquest Identifier: 1435981111

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AtriCure to Participate at the Rodman & Renshaw Investor Conference

Lead Author: [none given]

Additional Authors:

PR Newswire. New York:, 2008-02-29

AtriCure, Inc. (Nasdaq: ATRC), a medical device company and a leader in cardiac surgical ablation systems, today announced its participation at the upcoming Rodman & Renshaw "Straight to the Heart" conference at the Boston Harbor Hotel on Tuesday, March 4, 2008. Attendance at the conference is by invitation only. The conference format is comprised of one-on-one meetings with no large group presentations scheduled.

About AtriCure, Inc.--AtriCure, Inc. is a medical device company and a leader in developing, manufacturing and selling innovative cardiac surgical ablation systems designed to create precise lesions, or scars, in cardiac, or heart, tissue. Medical journals have described the adoption by leading cardiothoracic surgeons of the AtriCure Isolator(R) bipolar ablation system as a treatment alternative during open-heart surgical procedures to create lesions in cardiac tissue to block the abnormal electrical impulses that cause atrial fibrillation, or AF, a rapid, irregular quivering of the upper chambers of the heart. Additionally, medical journals and leading cardiothoracic surgeons have described the AtriCure Isolator(R) system as a promising treatment alternative for patients who may be candidates for sole-therapy minimally invasive procedures. AF affects more than 5.5 million people worldwide and predisposes them to a five-fold increased risk of stroke.

The FDA has cleared the AtriCure Isolator(R) bipolar ablation system, including the new Isolator Synergy(TM) ablation clamps and the AtriCure multifunctional bipolar Pen, for the ablation, or destruction, of cardiac tissue during surgical procedures. Additionally, the FDA has cleared AtriCure's multifunctional Pen for temporary pacing, sensing, stimulating and recording during the evaluation of cardiac arrhythmias. To date, the FDA has not cleared or approved AtriCure's products for the treatment of AF. AtriCure's left atrial appendage exclusion system has not been approved for commercial use. It is currently being used in clinical evaluations in Europe.

MIB Abstract ID Number: 14638

Proquest Identifier: 1438240031

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