MedIntelliBase® NewsTips     February 2007

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Table of Contents
1) Endovascular Therapeutics
2) Carotid Therapeutics & Stroke Prevention
3) New MedIntelliBase Alerts 
4) Link of the Month Go Red For Women
  • Go Red For Women - Did you know? Heart disease is the #1 killer of women in America. Support the AHA's Go Red For Women program...
5) Fun Fact of the Month
6) MedIntelliBase Alerts & MarketTracks>>
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1) Endovascular Therapeutics

Zilver PTX Drug Eluting Stent Trial - Initial results from the first international peripheral paclitaxel drug-eluting stent (DES) trial

Preliminary results from the ZILVER PTX Drug-Eluting Stent Trial were described at the International Symposium on Endovascular Therapy (ISET) meeting on January 30, 2007. This study is a randomized trial designed to evaluate the safety of the Cook, Inc. ZILVER PTX paclitaxel-eluting peripheral stent used in the treatment of blockages of the superficial femoral artery (SFA) above the knee. This is the first trial to investigate whether Paclitaxel-eluting stents can be used to successfully treat peripheral arterial disease (PAD).

Michael Dake, MD, professor and chairman of the department of radiology at the University of Virginia Health System and the trial’s principal investigator, presented nine-month data on the study’s first 60 patients. Dr. Dake reported that the ZILVER PTX stent showed an equal major adverse event (MAE) rate to conventional angioplasty for treating SFA lesions. The ZILVER PTX stent also displayed a zero-percent fracture rate for 41 lesions at six months and 18 lesions at one year. Data from this study was compiled based on enrollment in the pilot portion of the clinical investigation which began March 2005 and was completed last year.

Other clinical research for Cook's ZILVER PTX stent...
  • Enrollment of 420 patients in 50 sites in the pivotal trial (Phase II) to evaluate the effectiveness of the device is expected to begin in 2007.
  • Additionally, a ZILVER PTX registry with a target enrollment of 700 patients is ongoing worldwide to collect data supporting this technology.
  • Learn more about all companies' clinical trials and registries research with MedIntelliBase MarketTracks
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RockHawk & SpideRX - Atherectomy in calcified peripheral artery lesions

A specialized version of the FoxHollow Technologies SilverHawk plaque excision system, designed with rotating carbide blades, is under development. This new RockHawk plaque excision system is designed to shave and remove calcified plaque from the arterial wall.

As part of a January 2007 agreement between eV3, Inc. and FoxHollow, FoxHollow will have the exclusive rights to market the combination of the RockHawk & eV3 SpideRX embolic protection systems in the United States. The companies have noted a yet-unnamed clinical trial is in development to evaluate the combined use of the RockHawk & SpideRX systems in the treatment of peripheral artery disease. It is expected that the study's aim will be to seek approval for the treatment of calcified peripheral artery lesions.

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2) Carotid Therapeutics & Stroke Prevention

Carotid Artery Stenting...Not Just for Symptomatic Stroke Patients

Recent results of clinical studies continue to show the benefits of Carotid Artery Stenting (CAS), now more pointedly improving the quality of life for asymptomatic patients as well as symptomatic patients. Oral presentations given early this month at the International Symposium on Endovascular Therapy (ISET) seem to further validate Carotid Artery Stenting (CAS) for a broader spectrum of patients in terms of symptoms and age.

One in particular, a small patient study presented by Rodney Raabe, M.D., chief of radiology, Sacred Heart Medical Center, Spokane, WA, offered new findings on CAS outcomes. Originally he presented this small patient study at the SIR in April, 2006 highlighting patient Dementia Rating Scale (DRS-2), North American Adult Reading Test (NAART), and Rey Auditory-Verbal Learning Test (RAVLT) results. At the time DRS-2, NAART and the RAVLT were conducted prior to and following the CAS procedure. The objective of Dr. Raabe's study was to test the safety and efficiency of CAS in 62 patients, with 37 patients surviving to one year post-treatment - both symptomatic (n = 15) and asymptomatic (n = 22).

Dr. Raabe presented 6-month and 1-year follow up results for the DRS-2 test at ISET 2007, expanding on his earlier SIR presentation. Dr. Raabe noted, "One of the biggest debates in carotid artery disease is whether to treat so-called 'asymptomatic' patients: those who have clogged carotid arteries but don't have early warnings of stroke, such as transient ischemic attacks (TIAs), or mini-strokes."

The data presented at ISET 2007 showed 43% of all patients who underwent CAS realized a vast improvement in brain functions such as memory, judgment and reasoning according to the DRS-2 neurocognitive test. This study presents a significant challenge to the current understanding of CAS as results suggest there soon may be clinical proof for percutaneous intervention to reverse brain function defe even though a patient may not be at risk of stroke. In his concluding remarks Dr Raabe added, "I think that asymptomatic patients who have been forgetful or seem confused or have trouble with memory problems may actually be showing symptoms of carotid artery narrowing... and these individuals should be treated."

More specific neurocognitive test data showed a baseline mean memory score of 9.20. Six (6) month follow-up results demonstrated that mean memory score had improved to 10.60 (p = .024) and at 1 year the score achieved statistical significance at 10.89 (p = .008). Likewise, the executive function score initially was 9.60 at baseline, at 6 months 10.50 (p = .033) and at 1 year 10.78 (p = .001) again achieving statistical significance. The total score achieved statistical significance at 1 year (p = .001).

However, octogenarians may be one patient group where the benefits of CAS do not outweigh other treatment options, including carotid endarterectomy (CEA) and medical therapy. Among a subgroup of patients (n=378) aged at least 80 years in the recent CAPTURE trial (Carotid Acculink/Accunet Postapproval Trial to Uncover Rare Events), 7.7% experienced the primary endpoint of death, stroke or myocardial infarction (MI) at 30 days, whereas a significantly lower rate of 4.3% was observed in the subgroup of patients younger than 80 years (n=1,224). Furthermore, this trend was seen in both asymptomatic (6.4% vs. 3.5% respectively, p=significant) and symptomatic (14.2% vs. 4.9% respectively, p=significant) patients.

Dr. Frank J. Criado, chief of vascular surgery at Union Memorial Hospital, Boston notes that additional negative outcomes can occur in the elderly as compared to the general population. According to Dr. Criado, octogenarians may be especially vulnerable to neurologic deficits that can occur with carotid stenting, despite the use of embolic filters. Commenting on the CAPTURE trial, Dr. William A. Gray, Columbia University Medical Center, New York, NY, expects that further analysis of the data will help physicians better understand the optimal therapeutic options for symptomatic and asymptomatic patients. Look for future coverage of CAS in octogenarians in upcoming MIB NewsTips issues.

Interested in keeping up to date on this issue? Is there another  area of interest where you need current, timely clinical research or technology development information? Click here to learn more about our MIB Alerts and MarketTracks - A Better stay up to date.

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3) MedIntelliBase Alerts MIB Alerts
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4) Link of the Month
  • Go Red For Women - At this most appropriate time of the year...Visit and support the AHA's program that is spreading the word about the #1 killer of American women as well as men --> Heart Disease. [The American Heart Association]

Go Red For Women
Images courtesy of
The American Heart Association
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5) Fun Fact the Month
  • A Truly Radiant Heart - Researchers from the College of Veterinary Medicine at Cornell University have found a way to make the hearts of mice glow green with each heart beat. Beyond being an interesting "trick" - researchers are evaluating this technique to study the interaction and communication of cells within a heart and their surrounding environment... [Access Excellence @ The National Health Museum]
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6) MedIntelliBase Alerts and MarketTracks >> A Better Way ...

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MedIntelliBase MarketTracks tackle critical clinical research and technology development findings in interventional vascular medicine:
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Editor: Vicky Hunsicker Sanko
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Market Research Analyst: Jordan Zornes
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© The Next Phase® Consultancy, Inc. 2007. All rights reserved.

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