MedIntelliBase® NewsTips     February 2007

Your monthly newsletter from the
"better way to access market intelligence" people at medintellibase.com

MedIntelliBase® NewsTips...A Better Way...to stay up-to-date


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>>
A Better Way...to Access Market Intelligence
  • MIB Alerts: Convenient and timely, Easy to Use, Tightly Focused Customized Email Alerts
  • MIB MarketTracks: Searchable, Easy to Use, Comprehensive Online Database
 
7) More Information Available at www.MedIntelliBase.com
 
Return to Top
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
Return to Top

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.

Return to Top

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 Way...to stay up to date.

Return to Top

3) MedIntelliBase Alerts MIB Alerts
  • Click the banner above to view a sample Custom Email Alert. Stay up-to-date by email on relevant industry publications and announcements as they occur
Return to Top 

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
Return to Top

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]
Return to Top

6) MedIntelliBase Alerts and MarketTracks >> A Better Way ...

Does this "quest for Market Intelligence" sound familiar?
  1. Search for multi-client market studies
  2. Agonize over the high prices
  3. “Bite the bullet” and purchase a report
  4. Skim the report for useful information
  5. Marvel at the lack of depth and double- or triple- spaced pages
  6. Recognize that the information in the report was only slightly out of date when the report was published - 18 months ago
  7. Spend hours trying to find the latest developments on Medline or Google
  8. Get frustrated at the inability to find what you need
  9. Write your report or your business plan that you know should be better, more in depth...if only you had better information
  10. Vow that next time, you’ll find a better way

MedIntelliBase Alerts and MarketTracks give you just that...A Better Way:

     
MIB Alerts

MedIntelliBase Custom Email Alerts are highly flexible, customized intelligent search filters powered by "Human Intelligence™" that give you convenient, timely, and tightly focused updates on new developments in your industry segment. MIB Alerts are especially suitable for busy Marketing, Business Development, and General Management executives in medical device and biotechnology companies.

  • Convenient and Timely >>
    • Respond to new developments in real time, not weeks or months later
    • Keep you up-to-date on relevant industry events and announcements as they occur
    • Pushed to you via email, no need to login for news
  • Easy to use >>
    • MIB Alerts do the work for you. You become the "industry expert" in your organization
    • Easy-to-read and navigate alerts and archives
    • Accessible from anywhere, from Outlook or any web browser
  • Customized and Tightly Focused >>
    • Save you time and make you more effective
    • You receive only those specific developments that matter to you
    • You don't receive useless filler and irrelevant search hits - MIB's "Human Intelligence™" ("HI™") removes the fluff

A few examples of thousands of possibilities:

  1. Peripheral Arterial Occlusion (PAO) - Thrombolysis
  2. Cardiac Structural Defects
  3. Lower Limb PAD & Atherectomy
  4. PV Angiography - Infusion Catheters
  5. CV/PV Angiography - Power Injectors
  6. Deep Vein Thrombosis (DVT) - Thrombolysis
  7. Neurostimulation - Hearing Loss
  8. Neurostimulation - Alzheimer's disease
  9. Neurostimulation - Parkinson's disease
  10. Pharmaceuticals - Parkinson's disease & Essential Tremor
  11. Advanced Therapies - Parkinson's & Essential Tremor
  12. Spinal motion preservation
  13. Hip Resurfacing
  14. Knee Resurfacing
  15. Resuscitation
 

The type of information you specify:

  • Clinical article abstracts
  • Trials and registries results
  • Preclinical article abstracts
  • Industry announcements
  • Press releases
  • Conference notices & proceedings
  • Technology developments
  • Patents issued & challenged
  • Lawsuits & other legal issues
  • FDA & voluntary product recalls
  • And more

 

Click the banner below to view sample MIB Custom Email Alert formats - a Full Alert, or one of the "QuickView" formats --> Lean Alert or UltraLean Alert:



MIB Alerts

     
MIB MarketTracks

MedIntelliBase MarketTracks are searchable, comprehensive databases for specific industry segments covering developments in breaking clinical trials and registries, emerging technologies and products, and competing companies. They are customizable, updated regularly and accessible from anywhere, from any web browser. MIB MarketTracks are especially useful to Marketing, Business Development, and Research & Development executives in medical device and biotechnology companies.

  • Access your MarketTracks from anywhere >> online service
  • Packed with the latest information >> updated as new industry and late breaking trials announcements occur at major conferences***
  • Receive significantly more information than competing reports >> twice the depth & breadth of coverage
  • Easy to search >> all information in a cross-linked, searchable database
  • Fits within your budget >> competitively priced and customized subscriptions to meet your needs
  • Access online and offline >> PDF report & database search results downloadable & printable >> all included in your acquisition price
MedIntelliBase MarketTracks tackle critical clinical research and technology development findings in interventional vascular medicine:
***Late breaking as well as archived information on pivotal trials and registries and emerging technologies remains available to you within the MIB databases for years to come - enabling you to track years of developments and history so you and your team do not repeat past mistakes.

You get much greater value from customizable MIB Alerts and MarketTracks than from standard market reports and search engines. You choose the exact depth and breadth of intelligence required, realizing the greatest value for your market intelligence money.

Interested? Want to know more? Want a trial?

Contact us for:
  • More information
  • Real-Time MedIntelliBase Tour
  • Free 15-Day Trial Subscription
Return to Top

7) More Information Available at www.MedIntelliBase.com

You can find more in-depth information about the details noted above and many other technologies and clinical studies tracked over the years at MedIntelliBase MarketTracks - visit the website at www.MedIntelliBase.com or request more information on the site.

MedIntelliBase MarketTracks and Alerts will help you find the critical intelligence you need to make informed product development and business investment decisions.

Contact MedIntelliBase directly...

Return to Top


FYI:
  1. MedIntelliBase NewsTips is free and you are welcome to continue receiving it as long as you wish. If at any time you wish to cancel just click the Safe Unsubscribe link below.
  2. We will not share your name and e-mail address with anyone.
  3. Feel free to share or reproduce the information in this MedIntelliBase NewsTips e-newsletter (in whole or part) as long as proper mention and copyright notice is given to MedIntelliBase and The Next Phase Publishing, Inc.
  4. If you are not the original recipient of this newsletter and would like to receive future issues, just click the Forward link below or drop us a line.

Editor: Vicky Hunsicker Sanko
The Next Phase Publishing**

Market Research Analyst: Jordan Zornes
The Next Phase Publishing**
Phone - 425/894-4147

www.MedIntelliBase.com
Toll Free - 800/390-2756
Fax - 866/381-6119

© The Next Phase® Consultancy, Inc. 2007. All rights reserved.

** A division of Next Phase® Consultancy, Inc.

Return to Top