Feds approve another BSX stent system
Marlborough-based Boston Scientific Corp. has received federal approval for its latest stent system designed to treat coronary artery disease.
The U.S. Food and Drug Administration’s sign-off will allow Boston Scientific to make the REBEL Platinum Chromium Coronary Stent System available across the country by Aug. 1, according to a company spokesman. The device achieved CE Mark approval, a European manufacturing conformity requirement, in February.
Coronary heart disease is a narrowing of the blood vessels that supply blood and oxygen to the heart, and placement of a stent system helps keep an artery open to enhance blood flow.
According to Boston Scientific, the Rebel works off an identical platform as the Promus PREMIER Drug-Eluting Stent – which was approved by the FDA in November 2013 – but doesn’t require use of the the company’s market-leading drug Everolimus. The Rebel will allow for the treatment of patients who are incapable of receiving a drug-eluting stent, according to Dr. John D. Wang of Medstar Union Memorial Hospital in Baltimore.
“Launching the Rebel Stent System in the U.S. is another important step to ensure that we offer physicians the most differentiated and broadest product portfolio possible,” Kevin Ballinger, president of Boston Scientific’s Interventional Cardiology business, said in a statement.
The Rebel is offered in 46 sizes, and features unparalleled visibility and low recoil, the company said.
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