Boston Scientific Wins CE Mark for Stent with Bare Essentials

Boston Scientific Corp. has received CE Mark approval to offer its bare-metal Rebel coronary stent system on the European cardiovascular market.

Rebel features Natick,MA-based Boston Scientific's advanced-architecture platinum-chromium stent technology and provides physicians with enhanced treatment options for coronary artery disease (CAD) patients.The stent is basically the same device as the company's Promus Premier drug-eluting stent (DES), but without that model's Everolimus drug coating. In the United States, the Rebel stent system is an investigational device and is not FDA approved for sale. While drug-eluting stents create most of the buzz, some patients are not suitable candidates for the drug therapy. Boston Scientific says that bare-metal stents continue to play an important role in the treatment of CAD, and still command a significant portion of the global stent market. According to the Boston Scientific news release from last Wednesday announcing the approval, "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.""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 Didier Carrie, MD, PhD, at the Centre Hopital Universitaire in Rangueil, France. Carrie was an investigator in Boston Scientific's Omega stent multi-center clinical trial.

While the Promus Premier stent is offered in 94 sizes, the Rebel stent is currently offered in a matrix of 48 sizes that range in diameter from 2.25 to 4.50 mm. The Rebel is available in lengths of 8 to 32 mm, and is deployed on the company's Monorail catheter platform.

Stephen Levy is a contributor to Qmed and MPMN.