Boston Scientific Receives FDA Approval for Rebel Platinum Chromium Coronary Stent System

Boston Scientific Corporation has received FDA approval for the Rebel Platinum Chromium Coronary Stent System, the company’s latest generation bare-metal stent for the treatment of coronary artery disease (CAD). The company announced CE Mark for the Rebel Stent System in February.

The Rebel Stent System features a proprietary platinum chromium (PtCr) alloy and a customized stent architecture design. It offers an identical stent platform to the Promus Premier drug-eluting stent (DES), but without the everolimus drug.

“Bare-metal stents are an important part of our practice, as not every patient can receive a drug-eluting stent. This new bare-metal stent has the same great visibility and deliverability as the Premier DES, but allows me to treat patients who are not candidates for DES therapy,” said John C. Wang, MD, of Medstar Union Memorial Hospital, Baltimore, Md. “In addition, the platinum chromium architecture provides great radial strength with low recoil, which is particularly important in patients receiving bare-metal stents.”

The Rebel Stent System features high visibility, low recoil, exceptional radial strength and fracture resistance, while improving axial strength and deliverability. Its enhanced low-profile delivery system also features a shorter, more visible tip, a dual-layer balloon and a Bi-Segment inner lumen catheter designed to facilitate precise stent delivery across challenging lesions.

Of note, Dr. Wang presented data from the OMEGA clinical trial evaluating the Rebel Stent System in February at the Cardiovascular Research Technologies conference in Washington, D.C. OMEGA is a single arm, multi-center trial in the U.S. and Europe and the first reported results showed low event rates at nine months. 

The Rebel Stent System is offered in a matrix of 46 sizes, ranging in diameter from 2.25 mm to 4.50 mm and lengths of 8 mm to 32 mm on a Monorail platform.