FDA Approves Boston Scientific's Synergy Bioabsorbable Polymer DES System

October 5, 2015—Boston Scientific Corporation announced US Food and Drug Administration (FDA) approval for the Synergy bioabsorbable polymer, drug-eluting stent system (BP-DES) for the treatment of coronary artery disease. The company will commence commercialization of the Synergy, which is the first BP-DES available in the United States. The Synergy stent received European CE Mark approval in 2012.

According to Boston Scientific, the Synergy features ultrathin stent struts with an abluminal bioabsorbable drug/polymer coating technology. The drug coating and the polymer, which modulate drug release, are fully absorbed shortly after drug elution is complete at 3-months. The Synergy BP-DES provides synchronized drug and polymer absorption, enables rapid and complete arterial healing, and reduces the risk of complications associated with long-term polymer exposure, compared to currently available DES with permanent polymers. 

The company advised that results from the EVOLVE II trial demonstrated 0% definite stent thrombosis after 24 hours. EVOLVE II, which is part of the company’s clinical program to support FDA approval of the device, is a global, multicenter, randomized, single-blind, noninferiority pivotal trial designed to evaluate the performance of the Synergy BP-DES system compared to the company’s durable polymer Promus Element Plus DES system. The trial enrolled 1,684 patients in 125 sites worldwide, including the United States, Canada, Europe, Australia, New Zealand, Japan, and Singapore. 

Additionally, 4-year EVOLVE trial data demonstrated a continued 0% stent thrombosis rate and a target lesion revascularization rate of 1.1%.

In the company’s press release, EVOLVE II Principal Investigator Dean Kereiakes, MD, commented, “Data from the EVOLVE II trial, which included the most complex patient population studied in a United States regulatory approval stent trial, demonstrated exceptional performance and safety of the Synergy stent. The United States cardiology community will have access to a bioabsorbable polymer DES which will provide excellent clinical outcomes and should optimize vessel healing.” Dr. Kereiakes is Medical Director at The Christ Hospital Heart & Vascular Center/The Lindner Research Center in Cincinnati, Ohio.

Boston Scientific advised that it expects to initiate the EVOLVE Short Dual Anti-Platelet Therapy (DAPT) study during the first quarter of 2016 to further assess the Synergy BP-DES. The company has received an investigational device exemption from the FDA for this prospective study that is designed to assess the safety of 3-month use of DAPT in patients at high risk for bleeding while undergoing percutaneous coronary intervention with the Synergy stent.