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FDA approves Boston Scientific’s Synergy BP-DES system

Medical equipment manufacturer Boston Scientific has obtained approval from the US Food and Drug Administration (FDA) for its Synergy bioabsorbable polymer drug-eluting stent system (BP-DES) to treat coronary artery disease (CAD).

Synergy

The Synergy system, which offers synchronized drug and polymer absorption, was designed to enable more rapid and complete arterial healing and reduce the risk of complications associated with long-term polymer exposure.

Boston Scientific interventional cardiology president Kevin Ballinger said: "The introduction of the first bioabsorbable polymer stent in the U.S. is a tremendous milestone in the evolution of stent technology.

"The Synergy stent is a next generation therapy designed to improve patient outcomes and ultimately reduce health care costs associated with the treatment of coronary artery disease."

The Synergy is the bioabsorbable polymer stent, which features ultrathin stent struts with an abluminal bioabsorbable drug/polymer coating technology that is absorbed shortly after drug elution is complete at three months.

Synerg system’s Evolve II trial demonstrated 0% definite stent thrombosis (ST) after 24 hours, while four-year Evolve trial data showed a continued 0% stent thrombosis rate and a very low target lesion revascularization (TLR) rate of 1.1%., according to the company.

The firm also received FDA investigational device exemption (IDE) approval for Evolve short dual anti-platelet therapy (DAPT) study of Synergy stent, which is expected to start in the first quarter of 2016.

The trial was designed to evaluate the safety of three-month use of DAPT in patients at high risk for bleeding undergoing percutaneous coronary intervention (PCI) with the Synergy stent.

In September, Boston Scientific introduced a new Captivator endoscopic mucosal resection (EMR) device, which was specifically designed for EMR in upper gastrointestinal (GI) tract.


Image: Boston Scientific has obtained FDA approval for Synergy stent system to treat coronary artery disease. Photo: courtesy of Boston Scientific Corporation.