- The FDA approves Boston Scientific's (NYSE:BSX) SYNERGY Bioabsorbable Polymer Drug-Eluting Stent System (BP-DES) for the treatment of coronary artery disease. Both the drug coating and polymer which modulates drug release are fully absorbed shortly after drug elution is complete at three months. SYNERGY is designed to enable more rapid and complete arterial healing via synchronized drug and polymer absorption while reducing the risk of complications such as inflammation associated with long-term exposure to polymer from traditional drug-eluting stents.
- The data supporting the company's regulatory application was generated by the EVOLVE II study, a randomized, single-blind, non-inferiority pivotal trial that showed 0% definite stent thrombosis after 24 hours (no blood clotting). Four-year data showed a continued 0% stent thrombosis rate and a low 1.1% rate of lesion revascularization.
- A study assessing SYNERGY in patients at high risk of bleeding who are undergoing percutaneous coronary intervention (PCI) is expected to commence in Q1.
- Commercialization of the first and only BP-DES in the U.S. will begin immediately.
- SYNERGY received CE Mark clearance in 2012.