FDA approves Synergy Bioabsorbable Polymer Drug-Eluting Stent System to treat coronary artery disease- Boston Scientific

Boston Scientific has received FDA approval for the Synergy Bioabsorbable Polymer Drug-Eluting Stent System (BP-DES) for the treatment of coronary artery disease. With this FDA approval, Boston Scientific will commence commercialization of the first and only BP-DES in the U.S. Notably, both the drug coating and the polymer � The Synergy Stent provides synchronized drug and polymer absorption. It is designed to enable more rapid and complete arterial healing, and to thereby reduce the risk of complications associated with long-term polymer exposure compared to currently-used drug-eluting stents (DES) with permanent polymers

Existing DES devices reduce coronary restenosis, but the polymer remains on the stent after the drug is delivered. Long-term exposure to the polymer may cause inflammation, which delays healing and has been associated with complications, including neoatherosclerosis and stent thrombosis. The Synergy Stent is designed for faster and sustained healing by eliminating long term polymer exposure.

Comment:Results previously reported from EVOLVE II, a global, multi-center, randomized, single-blind, non-inferiority pivotal trial demonstrated 0% definite stent thrombosis (ST) after 24 hours. Four-year EVOLVE trial data demonstrated a continued 0% stent thrombosis rate and a very low target lesion revascularization (TLR) rate of 1.1%.

Comment: Synergy Bioabsorbable Polymer Drug-Eluting Stent System received CE Mark recommendation in November 2012.