The world's first drug-eluting bioresorbable vascular scaffold for the treatment of coronary artery disease has received CE Mark approval.
The ABSORB stent from Abbott Vascular can open and support a blocked artery, dissolving within two years to leave the blood vessel free of any implant.
"The CE Mark approval for ABSORB in Europe is a significant accomplishment that validates the impressive clinical results that have been observed with this device," said Patrick W. Serruys, Professor of Interventional Cardiology at Erasmus University Hospital, Rotterdam, the Netherlands.
"Abbott's ABSORB has the potential to change the way patients with coronary artery disease are treated, as it does what no other drug-eluting coronary device has been able to do before - completely dissolve and potentially restore natural vessel function."
ABSORB is an everolimus-eluting stent made from polylactide, which is used in resorbable sutures. A blood vessel treated with ABSORB may retain the ability to move, flex and pulsate, and the need for long-term dual anti-platelet therapy may be reduced.
"Our ABSORB technology has the potential to revolutionize the treatment of coronary artery disease," said Robert B. Hance, Senior Vice President, Abbott Vascular. "Abbott is committed to building the clinical and economic benefits of this therapy in anticipation of making it widely available in Europe by the end of 2012."
A successful three-year clinical trial of ABSORB has taken place. To support European commercialisation and reimbursement, Abbott plans a further controlled randomised trial in Europe with 500 patients, comparing ABSORB with Abbott's leading drug-eluting stent XIENCE PRIME.
A full-scale European commercial launch of ABSORB is planned by the end of 2012.
Absorb stent
Share this article: