Boston Scientific's Rebel Platinum Chromium Coronary Stent System Receives CE Mark Approval

March 12, 2014—Boston Scientific Corporation (Natick, MA) announced that it has received European CE Mark approval for the Rebel platinum chromium coronary stent system, which is the company's latest-generation bare-metal stent for the treatment of coronary artery disease. The Rebel system, which is an investigational device in the United States, makes use of the same stent platform as Boston Scientific’s Promus Premier drug-eluting stent (DES) without the everolimus drug.

According to the company, the Rebel stent system is offered in a matrix of 48 sizes, ranging in diameter from 2.25 mm to 4.5 mm and providing lengths of 8 mm to 32 mm, on a Boston Scientific Monorail platform. The Rebel stent system provides visibility, radial strength, fracture resistance, and low recoil. The new-generation device also offers improved deliverability and axial strength. The low-profile delivery system features a shorter, more visible tip and a dual-layer balloon. The company’s Bi-Segment inner lumen catheter is designed to facilitate precise stent delivery across challenging lesions.

Boston Scientific advised that the Rebel stent is being evaluated in the single-arm, multicenter OMEGA trial that is being conducted in the United States and Europe. OMEGA trial data are expected to support a regulatory submission to the US Food and Drug Administration.

In February, John C. Wang, MD, from Medstar Union Memorial Hospital in Baltimore, Maryland, presented data from the OMEGA clinical trial at the CRT 2014: Cardiovascular Research Technologies conference in Washington, DC.

In the company’s press release, Prof. Didier Carrie, MD, an investigator for the OMEGA clinical trial at Centre Hopital Universitaire in Rangueil, France, commented, “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. 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.”