Boston Scientific 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 physicians 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 2.25mm to 4.50mm and lengths of 8mm to 32mm on a Monorail platform. Boston Scientific claims that its Rebel stent system has unparalleled visibility, low recoil, exceptional radial strength and fracture resistance, while improving axial strength and deliverability.
Dr John C Wang 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 US and Europe. The OMEGA trial data are expected to support a US Food and Drug Administration regulatory submission.
Boston Scientific Interventional Cardiology president Kevin Ballinger noted the company is committed to advancing cardiology and providing the best treatment options for all patients with coronary artery disease.
"This includes innovating and improving the performance of bare metal stent technology to enhance patient outcomes," Ballinger added.
The Rebel stent system in an investigational device in the US and is not available for sale in the country.