Abbott 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 enrol 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.

"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, 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 per cent (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, 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, 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 programme includes clinical trials in peripheral artery disease, carotid artery disease, and coronary artery disease.

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.

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.