CE mark for REBEL platinum chromium coronary stent system

Natick, Massachusetts – Continuing to advance leading stent technology, Boston Scientific Corp. 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). 

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

"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." 

The REBEL Stent System features unparalleled 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.

CAD is a narrowing of blood vessels that supply blood and oxygen to the heart. Patients with CAD may experience pain, shortness of breath and fatigue. They may also be at risk for a heart attack. A primary treatment for CAD is the placement of a stent in the artery to help keep it open and allow the blood to flow more freely.

"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."

The REBEL Stent System is offered in a matrix of 48 sizes, ranging in diameter from 2.25mm to 4.50mm and lengths of 8mm to 32mm on a Monorail platform. This provides physicians with a range of options designed to best suit patient needs. 

Data from the OMEGA clinical trial evaluating the Platinum Chromium Bare Metal Stent System were presented in February by John C. Wang, M.D., Medstar Union Memorial Hospital, Baltimore, Md. at the Cardiovascular Research Technologies conference in Washington, D.C. OMEGA is a single arm, multi-center trial in the U.S. and Europe. OMEGA trial data are expected to support a U.S. FDA regulatory submission. 

In the U.S., the REBEL Stent System is an investigational device and not available for sale. 

Source: Boston Scientific