Healthcare Industry News: XIENCE
News Release - March 24, 2009
Abbott Advances Its Revolutionary Fully Bioabsorbable Drug Eluting Stent With Initiation of Next Phase of Clinical TrialABBOTT PARK, Ill., March 24 (Healthcare Sales & Marketing Network) -- Abbott (NYSE: ABT) today announced the initiation of the next phase of the ABSORB clinical trial to evaluate the safety and performance of the company's fully bioabsorbable drug eluting coronary stent. This second phase of the ABSORB clinical trial will enroll approximately 80 patients at 10 centers in Europe, Australia and New Zealand, and will incorporate device enhancements designed to improve deliverability and vessel support. The first patient was enrolled into the second stage of the ABSORB clinical trial at Onze Lieve Vrouw Ziekenhuis Hospital in Aalst, Belgium, by Bernard De Bruyne, M.D., Ph.D.
"Interventional cardiology has come a long way. It started with balloon angioplasty, which evolved into bare metal stents and then drug eluting metal stents were created," said Patrick W. Serruys, M.D., Ph.D., professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, and principal investigator of the ABSORB trial. "Now we have the fourth revolution in interventional cardiology technology, and patient outcomes from the first stage of ABSORB clearly show that bioabsorbable devices are the future of coronary artery disease treatment."
Results from the first stage of the ABSORB trial with 30 patients demonstrated that Abbott's bioabsorbable everolimus eluting stent successfully treated coronary artery disease, and that at two years, the treated vessel was able to expand and contract, without being restricted by a permanent implant - indicating that the device was absorbed. In addition, there were no cases of thrombosis (blood clot formation) out to two years of follow-up, and no new major adverse cardiac events (MACE) between six months and two years, with the bioabsorbable device demonstrating a MACE rate of 3.6 percent (one patient) at two years. MACE is a composite clinical measure of safety and efficacy outcomes, defined as any event that resulted in re-treatment of the treated artery lesion (ischemia-driven target lesion revascularization), heart attack (myocardial infarction) or cardiac death.
"Based on the strong clinical outcomes from the first stage of Abbott's bioabsorbable device trial, interventional cardiologists have been eager to enroll their patients into the second stage of the trial," said John Ormiston, M.D., medical director at Mercy Hospital in Auckland, New Zealand, and co-principal investigator in the ABSORB trial. "If the bioabsorbable stent continues to perform well in this trial and subsequent larger trials with more complex narrowings, bioabsorbable device technology may become the new standard of care for patients with coronary artery disease."
Abbott is the only company with long-term clinical data (out to two years) evaluating the safety and performance of a fully bioabsorbable drug eluting coronary stent. Abbott's bioabsorbable everolimus eluting coronary device is made of polylactic acid, a proven biocompatible material that is commonly used in medical implants such as absorbable sutures. As with a metallic stent, Abbott's bioabsorbable device is designed to restore blood flow by propping a clogged vessel open, and to provide support until the blood vessel heals. Unlike a metallic stent, however, a bioabsorbable device is designed to be slowly metabolized by the body and completely absorbed over time.
"Abbott has been on the front lines of innovation in stent technology, and the fully bioabsorbable device is on track to become a clinical reality for patients," said John M. Capek, Ph.D., executive vice president, Medical Devices, Abbott. "Abbott is the furthest ahead in its clinical programs to bring a bioabsorbable drug eluting device to patients, and the company is committed to continuing to invest in this promising technology and to bring it to market as soon as possible."
The ABSORB trial reinforces Abbott's commitment to research and develop innovative devices in vascular care. Abbott's robust vascular research program includes clinical trials in peripheral artery disease, carotid artery disease, and coronary artery disease. Key products in the vascular pipeline include: the Omnilink Elite(TM) Peripheral Stent System; the EMBOSHIELD NAV6(TM) Embolic Protection System for carotid stenting; and the XIENCE PRIME(TM) Everolimus Eluting Coronary Stent System, which builds upon the proven performance of Abbott's market-leading XIENCE V® Everolimus Eluting Coronary Stent System.
Onmilink Elite, EMBOSHIELD NAV6 and XIENCE PRIME are investigational devices and are not available for sale.
About the ABSORB Clinical Trial
The ABSORB trial is a prospective, non-randomized (open label), two-phase study designed to enroll approximately 110 patients in Australia, Belgium, Denmark, France, the Netherlands, New Zealand, Poland and Switzerland. Key endpoints of the study include assessments of safety - MACE and stent thrombosis rates - at 30 days; six, nine, 12 and 18 months; and two years, with additional annual clinical follow-up for up to five years, as well as an assessment of the acute performance of the bioabsorbable drug eluting stent, including successful deployment of the system. Other key endpoints of the study include imaging assessments by angiography, intravascular ultrasound (IVUS), optical coherence tomography (OCT), and other state-of-the-art invasive and non-invasive imaging modalities at six months, one year and two years.
Abbott's bioabsorbable drug eluting device delivers everolimus, a drug that inhibits tissue proliferation. The device props open and supports a narrowed blood vessel until the vessel heals, restoring blood flow, and is absorbed over time by the vascular tissue as part of the body's normal processes. If clinical results are positive, bioabsorbable drug eluting stents could eventually offer an alternative to the metallic drug eluting stents available to patients today.
About XIENCE V
Abbott's market-leading XIENCE V drug eluting stent was approved by the U.S. Food and Drug Administration and launched in July 2008, and was launched in Europe and other international markets in October 2006. XIENCE V is an investigational device in Japan and is currently under review by Japan's Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency.
Additional information about XIENCE V, including important safety and effectiveness information, is available online at www.XIENCEv.com.
Everolimus, developed by Novartis Pharma AG, is a proliferation signal inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its drug eluting stents. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent implantation, due to its anti-proliferative properties.
About Abbott Vascular
Abbott Vascular, a division of Abbott, is one of the world's leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development, and advancing medicine through training and education. Headquartered in Northern California, Abbott Vascular offers a comprehensive portfolio of vessel closure, endovascular and coronary products.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 72,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's Web site at www.abbott.com.
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