Abbott Park, IL - The world's first market approved, bioabsorbable stent will soon be available in Europe, with Abbott announcing today that it has received CE Mark approval for the Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) stent. The stent utilizes a poly-L-lactide polymer and is approved for the treatment of coronary artery disease.
Approval is based on the ABSORB clinical trials, previously reported by heartwire, showing the feasibility of the BVS device and the durability of its antirestenotic properties. Imaging studies published in 2009, also reported by heartwire, showed that at least one-third of the stent had been absorbed by the vessel wall by two years. Patients in the ABSORB trial have now been followed out to three years, according to the company.
Larger studies are still in the works, however, including a European trial that will enroll approximately 500 patients at 40 centers. In this study, patients will be randomized to the Absorb BVS stent and to Abbott's Xience PRIME stent, which has a permanent cobalt-chromium platform, while a global trial, which will include centers in the US, is planned for late 2011.
The Absorb stent will be available in a select number of sizes at various European centers in 2011, but a full commercial launch is expected in 2012, according to Abbott.
The potential for a stent that does its job and then disappears, with no long-term need for dual antiplatelet therapy, has been a holy grail in interventional cardiology. Even those excited about the technology, however, have worried about its deliverability and whether the stent can achieve the same low rates of restenosis seen with some of the newest permanent-scaffold drug-eluting stents.