Boston Scientific Earns FDA's First Approval For Bioabsorbable Polymer-Coated Stent
The FDA has signed off on Boston Scientific’s SYNERGY Bioabsorbable Polymer Drug-Eluting Stent System (BP-DES), which was designed to reduce risk of long-term polymer exposure and improve arterial healing in patients with coronary artery disease. This announcement follows an extensive clinical study that demonstrated promising results in a comprehensive mix of patients.
Drug-eluting stents (DES) currently in use have shown significant advantages over their bare metal stent predecessors in reducing the risk of a recurring blockage. In DES, a polymer coating over metal mesh slowly emits a drug, which helps prevent the growth of scar tissue in the artery lining. Studies have shown that the permanent polymer coating poses a two percent risk of long-term problems if left inside the body, compromising the device’s improved safety features.
Boston Scientific, though, designed SYNERGY so that the drug and polymers dissolve at the same time, and after three months of use, the polymer coating has been fully absorbed by the body. This innovation is geared toward reducing risks such as inflammation and long-term blood clotting associated with polymer exposure.
“We believe that [SYNERGY] is a premium workhorse drug-eluting stent that eliminates long-term polymer exposure, promotes optimal healing and provides confident deliverability,” said Kevin Ballinger, president of the Interventional Cardiology division at Boston Scientific, in a 2012 press release.
The SYNERGY Stent technology received CE Mark approval in 2012, shortly after researchers launched EVOLVE II, an investigation of the device that Boston Scientific claims included one of the most comprehensive populations of patients ever used in a U.S. stent trial.
In a recent press release, Dean Kereiakes, cardiovascular specialist and principle investigator of the trial, remarked, “Data from the EVOLVE II trial, which included the most complex patient population studied in a U.S. regulatory approval stent trial, demonstrated exceptional performance and safety of the SYNERGY Stent.”
Researchers reported that no patients using the stent experienced definite stent thrombosis after 24 hours, and that zero percent rate continued for four years. Only 1.1 percent of participants experienced lesion revascularization.
Ballinger commented in the press release that SYNERGY was a next-generation therapy designed to improve patient outcomes, and said Boston Scientific would continue conducting clinical research to support its safety and efficacy.
Another trial, set to launch in the first quarter of 2016, will study the safety of the SYNERGY Stent when used alongside dual anti-platelet therapy (DAPT). In July, Boston Scientific launched a study of a fully absorbable scaffold for the treatment of atherosclerotic coronary lesions, which was designed using key design elements of Synergy.
Boston Scientific Sr. VP and CMO Craig Thompson told Boston Business Journal (BBJ) that the market for stents, the largest category of products produced by his company, is worth $1.3 billion annually in the U.S. and $4 billion globally. Thompson added that he anticipates a widespread market for SYNERGY because of its proven safety in both high- and low-risk patients.