Abbott Laboratories Inc. commences overseas launch of its Absorb drug-eluting, fully bioabsorbable vascular scaffold for coronary artery disease, the world’s first. Announced Sept. 25, the launch includes Europe and parts of the Asia Pacific and Latin America regions. Unlike current stents on the market made of metal, Absorb is made of polylactide polymer. Since the everolimus-eluting scaffold dissolves over the course of two years as coronary lesions heal, the device could eliminate the potential for certain long-term adverse events associated with conventional drug-eluting metal stents, such as the formation of blood clots, and the need for blood clot medication, Abbott says. The device gained CE mark status last year. (See Also see "Abbott Sees Absorb Bioresorbable Implant As Stent Market Game Changer" - Medtech Insight, 17 January, 2011..) The company hopes to initiate a U.S. pivotal trial by year-end, with a PMA submission following in 2015. Other firms developing stent-like bioresorbable vascular scaffold products include Biotronik and Reva Medical.
Abbott’s Absorb has the potential to reduce inflammation and long-term disease progression compared to conventional bare-metal and drug-eluting stents, according to the company.