CE Mark for Boston Scientific’s REBEL™ Platinum Chromium Coronary Stent

Boston Scientific Corporation has received CE Mark 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).

Background

CAD, a narrowing of blood vessels that supply blood and oxygen to the heart can leave patients experiencing pain, shortness of breath and fatigue. These days primary treatment takes the form of stent placement in the artery to help keep it open and allow the blood to flow more freely. But which stent from the many on the market depends on physician preference and patient suitability. Bare metal stents continue to play an important role in the treatment of coronary artery disease and represent a significant portion of the global stent market.

Developed to expand the Boston Scientific platinum chromium customized architecture family of stents, the REBEL Stent System offers physicians the same stent platform as its Promus PREMIER™ Drug Eluting Stent (DES) but without the Everolimus drug.

Boston Scientific claims unparalleled visibility, low recoil, exceptional radial strength and fracture resistance for its REBEL Stent System, all in a device with improved 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.

The REBEL Stent System remains an investigational device in the U.S. and not available for sale.

Physician comments

“I am glad to have a bare metal stent that performs like the PREMIER DES but allows me to treat patients who are not candidates for DES therapy,” said Prof. Didier Carrie, M.D., Ph.D., an investigator for the OMEGA clinical trial at Centre Hopital Universitaire, Rangueil, France. “In addition to its great visibility and deliverability, the platinum chromium stent architecture features low recoil that is particularly important for patients treated with bare metal stents.”

Company comments

“Boston Scientific is committed to advancing cardiology and providing the best treatment options for all patients with coronary artery disease,” said Kevin Ballinger, president, Interventional Cardiology, Boston Scientific. “This includes innovating and improving the performance of bare metal stent technology to enhance patient outcomes.”

Source: Boston Scientific Corporation, PR Newswire

 

published: March 13, 2014 in: Approval/Clearance, Boston Scientific, Cardio

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