Abbott announces positive results of bioresorbable vascular device at TCT conference

AbbottSep 23 2010

Abbott (NYSE: ABT) today announced positive nine-month results from the first 45 patients enrolled in the second stage of the ABSORB trial. At nine months, Abbott's bioresorbable vascular scaffold (BVS) demonstrated strong results that remained consistent with the six-month data from the same 45-patient group, with the rate of major adverse cardiac events (MACE) unchanged at 4.4 percent and no reports of blood clots (thromboses). These results were presented during the Cardiovascular Research Foundation's 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, D.C.

"I am impressed with how consistent the BVS data have been to date, as the nine-month data are compelling and supportive of earlier positive results," said John Ormiston, M.D., medical director at Mercy Hospital in Auckland, New Zealand, and co-principal investigator for the ABSORB trial. "In addition to the positive safety data we've seen to date, the late loss rate of 0.19 millimeters reported at six months is comparable to a metallic drug eluting stent, and may address a limitation of metal stents by not leaving metal in the artery. This technology is truly a step forward for the field of interventional cardiology, and I am excited about the prospect of treating patients with this revolutionary product."

Abbott also presented six-month results for all 101 patients enrolled in the second stage of the ABSORB trial. In this complete patient population, the MACE rate remained consistent, with a nominal increase from 4.4 percent at six months in the first 45 patients to 5.0 percent at six months in all 101 patients. There were no reports of blood clots in any of the 101 patients.

"We are pleased with the progress of ABSORB and the encouraging data we continue to see from the trial in the entire cohort of more than 100 patients," said Patrick W. Serruys, M.D., Ph.D., professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands, and principal investigator for the ABSORB trial. "The findings to date show that the device appears to effectively treat coronary artery disease with the possibility of restoring natural vessel function in a way that is not possible with permanent implants."

Abbott's BVS is under investigation in two clinical studies, ABSORB and ABSORB EXTEND, and is currently not available for sale anywhere in the world. The BVS is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as resorbable sutures. The bioresorbable technology is designed to restore blood flow by opening a clogged vessel and providing support until it is healed. Once the vessel can remain open without the extra support, the bioresorbable scaffold is designed to slowly metabolize and eventually be resorbed by the body. Since a permanent implant is not left behind, a vessel treated with a BVS may ultimately have the ability to move, flex and pulsate similar to an untreated vessel. The potential to restore these naturally occurring vessel functions, or vascular restoration, is one of the features that makes Abbott's BVS revolutionary in the treatment of coronary artery disease.