MedIntelliBase® NewsTips
July 2008
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In This Issue ...
FDA Approves XIENCE V Stent for Coronary Artery Disease
July 2, 2008 - Abbott Laboratories (Abbott Park, IL) Announces FDA Approval of its Drug-Eluting XIENCETM V Everolimus-Eluting Coronary Artery Stent System. Evaluated in the SPIRIT FIRST, SPIRIT II and SPIRIT III trials. XIENCE V is the first drug-eluting-stent (DES) to demonstrate superiority to the TAXUS® Express2 Paclitaxel-Eluting Coronary Stent System from Boston Scientific Corporation Inc. (Boston, MA).
The SPIRIT III clinical trial (see thumbnail trial summary image below left) compared the XIENCE V stent (see thumbnail product summary image below right) to the established DES, TAXUS Express2. Trial data for Abbott's XIENCE V showed a 44% reduction in MACE (major adverse cardiac events) at 9 months as compared to the TAXUS stent. For a full press release click here.
Click on the thumbnail image above to view the SPIRIT III study as a Clinical Trial Summary in MIB MarketTracks.
Click on the thumbnail image above to view XIENCE V Stent as a SMArt Product Summary in MIB MarketTracks.
FDA Approves Pathway PV System
July 21, 2008 marked a major turning point for Pathway Medical Technologies, Inc. (Kirkland, WA) with the FDA approval of its first vascular device. The Pathway PVTM Atherectomy System is indicated for pre-emptive removal of both hard and soft plaque in the lower limb caused by peripheral arterial disease. Sales are expected to commence in Q4 of this year. A full press release is available here.
FDA Approves Intracranial Stent for VISSIT Study
July 14, 2008 - A study of the new second generation stent, the PHAROSTM VitesseTM Stent produced by Micrus Endovascular Corporation (San Jose, CA) received FDA IDE approval. The Vitesse Intracranial Stent Study for Ischemic Therapy (VISSIT) uses “Micrus Endovascular's second balloon-expandable stent for the treatment of intracranial ischemic stenosis,” and is “designed to compare the clinical outcomes between patients treated with the stent and another medical therapy.” Clinical sites are now being set-up in the United States, Europe and China. For a full press release click here.
Site of the Month: CardioSmart - Link Your Site to It!
Now you can link your hospital, company or institution website to the new patient information site from the American College of Cardiology - This site offers free patient cardiovascular health information and is committed to “advertising-free,” unbiased information. Just click here to learn more.
Fun Fact: Tiny Medical Scanners...the First “Tricorder”?
Nuclear Magnetic Resonance Imaging allows for a "Miracle Diagnosis" - Handheld Medical Scanner 800 Times More Sensitive Than Full-size Scanners..." developed by Harvard University start-up, T2 Biosystems, Inc. (Boston , MA). According to blog author, Jason Mick, this “new scanner provides cancer, diabetes, and bacterial detection in the palm of your hand; also useful for anti-terrorist efforts.” His blog detailing how this device works is accessible by clicking here. Any Trekkies who remember Dr. McCoy and the amazing Tricorder?
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    MIB NewTips March 2008 Issue – Volume 3, Number 2

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