WASHINGTON (dpa-AFX) - Boston Scientific Corp. (BSX) said it has received approval from the U.S. Food and Drug Administration or FDA for the SYNERGY Bioabsorbable Polymer Drug-Eluting Stent System or 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 - which modulates drug release - are fully absorbed shortly after drug elution is complete at three months.
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 or DES with permanent polymers, the company stated.
Boston Scientific noted that 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.
Boston Scientific said it will continue to advance the robust clinical program supporting the SYNERGY Stent with the initiation of the EVOLVE Short Dual Anti-Platelet Therapy or DAPT Study, expected during the first quarter of 2016. The company has received an Investigational Device Exemption or IDE for this prospective study designed to assess the safety of three-month use of DAPT in patients at high risk for bleeding undergoing percutaneous coronary intervention or PCI with the SYNERGY Stent.
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