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Recommended Approval for the XIENCETM V Coronary Stent -- On November 29, 2007, Abbott Vascular (Redwood City, CA) announced that the Circulatory System Devices Advisory Panel to the FDA voted 9-to-1 to recommended approval for the XIENCE V Everolimus Eluting Coronary Stent System.
The SPIRIT III trial compared XIENCE to the established drug eluting stent (DES), TAXUS® Express 2M Paclitaxel-Eluting Coronary Stent. Data from the trial for Abbott's XIENCE V showed a 43% reduction in MACE as compared to TAXUS.
"The clinical and angiographic benefits of the XIENCE V stent compared to the most widely used drug eluting stent available in the U.S. have been consistent and significant across the SPIRIT trials,” observed PI, Gregg W. Stone, M.D., Columbia University Medical Center and the Cardiovascular Research Foundation, New York.
As part of its Guidant (Santa Clara, CA) acquisition agreement with Abbott Vascular, Boston Scientific (Boston, MA) also has the right to sell the XIENCE Stent System in the marketplace. If this strategic right were exercised, Boston Scientific would brand its system, "PROMUS," allowing the company to salvage losses in TAXUS market share.
For a MIB MarketTracks snapshot of the SPIRIT III Trial results please click on the thumbnail image below.  |
Dr. Judah Folkman (February 24, 1933 – 14 January 2008), a monumental leader in cancer research, giving hope to humanity has passed at the age of 74. Dr John Niederhuber, director of the National Cancer Institute, labeled Dr. Folkman as "the father of angiogenesis research." His belief that blood supply was the key to controlling cancer treatment, anti-angiogenesis therapy, was unwavering.
Dr. Folkman was the founder and director of the vascular biology program at the Children's Hospital and a professor of pediatric surgery and cell biology at Harvard Medical School, both in Boston. His service to humanity also included his contributions as a lieutenant in the United States Navy, where he worked at the National Naval Medical Center on ground breaking medical therapies such as an implantable device for timed-drug-release, Norplant, which he donated patent-free to the World Population Council.
Our condolences go out to Dr. Folkman’s friends and family. The world will miss this great man.
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EVEREST(a) Trial results - On January 22, 2008, Northstar Neuroscience, Inc. (Seattle, WA), reported that its pivotal trial did not meet its primary efficacy endpoint - evaluating cortical stimulation to improve hand and arm function in stroke survivors.
According to John Bowers, President and CEO of Northstar Neuroscience, "The EVEREST study did not confirm the positive results of cortical stimulation therapy for stroke motor recovery observed in prior feasibility studies. We are obviously very disappointed that the study missed its primary efficacy endpoint. We intend to work with our clinical collaborators to analyze the larger EVEREST data set with the goal of helping us better understand and evaluate the therapy's future potential."
The EVEREST trial was designed to determine whether the RenovaTM Cortical Stimulation System in conjunction with rehabilitation therapy would lead to greater gains in hand and arm function and activities of daily living than rehabilitation therapy alone.
For a MIB MarketTracks snapshot of this EVEREST Trial results please click on the thumbnail image below.
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Friday, February 1, is the fifth anniversary of National Wear Red Day...and it’s not just for women anymore! This day, whether woman or man, wear your favorite red clothes or accessory – women, a red blouse, a red dress pin, a head-to-toe red outfit - men, a red tie, red shirt or red socks. As the AHA says, “Take your heart health personally...Go red in your own fashion to show your support for women and the fight against heart disease!” |
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MIB NewTips January 2008 Issue – Volume 3, Number 1
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