Boston Scientific Gains CE Mark Approval for Coronary Stent System

Boston Scientific Corp. has obtained CE Mark approval for its Rebel platinum chromium coronary stent system, designed for the treatment of coronary artery disease (CAD).

Rebel is Boston Scientific’s latest generation bare metal stent system, which offers doctors the same stent platform as the Promus Premier drug eluting stent but without the Everolimus drug.

The low-profile delivery system 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.

It is offered in a matrix of 48 sizes, ranging in diameter from 2.25 millimeters to 4.50 millimeters and lengths of 8 millimeters to 32 millimeters on a Monorail platform. Boston Scientific claims its Rebel stent system has unparalleled visibility, low recoil, exceptional radial strength and fracture resistance, while improving axial strength and deliverability.

John C. Wang, M.D., from Medstar Union Memorial Hospital has presented data from the single arm, OMEGA clinical trial evaluating the Platinum chromium bare metal stent system at the Cardiovascular Research Technologies conference in Washington, D.C.
The OMEGA study was conducted in the United States and Europe. The OMEGA trial data are expected to support a U.S. Food and Drug Administration regulatory submission.

“This includes innovating and improving the performance of bare metal stent technology to enhance patient outcomes,” Boston Scientific Interventional Cardiology President Kevin Ballinger said.

The Rebel stent system is an investigational device in the United States and not yet available for sale.