Back in 2006 when we first started to report on Abbott‘s development of bioresorbable stents, we were quite optimistic. Now a representative for the company is telling us that Abbott has finally received European approval for the ABSORB stent, a device that eventually frees the vessel to be in its almost natural, pulsating and re-endothelialized state.
This is the world’s first drug-eluting bioresorbable stent and the plan is to slowly roll it out in Europe starting in a limited number of institutions and aiming for a full release toward the end of 2012.
ABSORB is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as resorbable sutures. Since a permanent metallic implant is not left behind, a patient’s vessel treated with ABSORB may ultimately have the ability to move, flex and pulsate similar to an untreated vessel. Restoration of these naturally occurring vessel functions, or vascular restoration therapy (VRT), is one of the features that makes ABSORB a significant innovation for patients in the treatment of coronary artery disease. In addition, continuing research indicates that the need to administer long-term dual anti-platelet therapy to patients may be reduced because the temporary scaffold is completely resorbed.
CE Mark approval for ABSORB in Europe was supported by data from the ABSORB clinical trials, which included patient follow-up out to three years. To further study the device in an expanded population, Abbott plans to initiate a randomized, controlled clinical trial in Europe later this year. The study will enroll approximately 500 patients at 40 centers throughout Europe and will compare ABSORB to Abbott’s XIENCE PRIME, which, together with XIENCE V, is the market-leading drug eluting stent system in Europe. The trial will provide additional data to support European commercialization and reimbursement activities. A global trial, including the U.S. and other geographies, is planned for later this year.
Press release: Abbott Receives CE Mark Approval for World’s First Drug Eluting Bioresorbable Vascular Scaffold for Treatment of Coronary Artery Disease
Flashbacks: Abbott’s Bioabsorbable Stent Showing Promise at Three Years; Abbott’s Bioresorbable Stent Continues to Prove Itself in Trials; Abbott Reports Positive Data from Study of Its Bioabsorbable Drug Eluting Stent; Dissolvable Heart Stents; Bioabsorbable Stents: So Far So Good