Following CE mark approval back in February, Boston Scientific has now gained U.S. FDA approval for its REBEL™ Platinum Chromium Coronary Stent System.
Background
The REBEL Stent offers the identical stent platform as the Promus PREMIER™ Drug-Eluting Stent (DES) but without the Everolimus drug. The new approval means that patients not candidates for drug eluting stents can still benefit from latest generation stent architecture. From Boston’s commercial perspective, bare-metal stents continue to play an important role in the treatment of CAD and represent a significant portion of the global stent market.
The REBEL Stent System expands the Boston Scientific family of stents featuring its proprietary platinum chromium (PtCr) alloy and a customized stent architecture design. Key features include claimed 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.
The REBEL Stent System is offered in a matrix of 46 sizes, ranging in diameter from 2.25 mm to 4.50 mm and lengths of 8 mm to 32 mm on a Monorail™ platform. This provides physicians with a range of options designed to best suit patient needs.
John C. Wang, M.D., of Medstar Union Memorial Hospital, Baltimore, Md presented data from the OMEGA clinical trial evaluating the REBEL Stent System in February at the Cardiovascular Research Technologies conference in Washington, D.C. OMEGA is a single arm, multi-center trial in the U.S. and Europe and the first reported results showed low event rates at nine months.
Physician comments
“Bare-metal stents are an important part of our practice, as not every patient can receive a drug-eluting stent. This new bare-metal stent has the same great visibility and deliverability as the PREMIER DES but allows me to treat patients who are not candidates for DES therapy,” said Dr Wang. “In addition, the platinum chromium architecture provides great radial strength with low recoil, which is particularly important in patients receiving bare-metal stents.”
Company comments
“Boston Scientific is committed to developing the best treatment options for all patients with coronary artery disease,” said Kevin Ballinger, president, Interventional Cardiology, Boston Scientific. “Launching the Rebel Stent System in the U.S. is another important step to ensure that we offer physicians the most differentiated and broadest product portfolio possible.”
Source: Boston Scientific Corporation, PR Newswire
published: July 22, 2014 in: Approval/Clearance, Boston Scientific, Cardio