Abbott has received the European CE mark for the first bioresorbable vascular scaffold (BVS) drug-eluting stent (DES) for the treatment of coronary artery disease.
Abbott's BVS device restores blood flow by opening a clogged vessel and providing support to the vessel until the device dissolves within approximately two years, leaving patients with a treated vessel free of a permanent metallic implant, according to the Abbott Park, Ill.-based company.
The BVS device will be commercialized under the brand name Absorb, and is made of polylactide, a biocompatible material 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 have the ability to move, flex and pulsate similar to an untreated vessel, Abbott said.
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. A global trial, including the U.S. and other geographies, is planned for later this year.
In addition to clinical trial product, Abbott said that Absorb will be made available in select sizes to a limited number of centers in Europe later this year and into 2012. A European commercial launch of Absorb is planned by the end of 2012.