FDA approves Rebel platinum chromium coronary stent system

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Boston Scientific has received FDA approval for the Rebel platinum chromium coronary stent system, the company’s latest generation bare metal stent for the treatment of coronary artery disease. 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. The company announced CE mark approval for the Rebel stent system in February.

The Rebel stent system expands the Boston Scientific family of stents featuring its proprietary platinum chromium (PtCr) alloy and a customised stent architecture design. The Rebel stent offers the identical stent platform as the Promus Premier drug-eluting stent but without the everolimus drug.

 


“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 drug-eluting stent but allows me to treat patients who are not candidates for drug-eluting stent therapy,” says John C Wang of Medstar Union Memorial Hospital, Baltimore, USA. “In addition, the platinum chromium architecture provides great radial strength with low recoil, which is particularly important in patients receiving 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.

 


Wang presented data from the OMEGA clinical trial evaluating the Rebel stent system in February at the Cardiovascular Research Technologies conference in Washington, DC.  OMEGA is a single arm, multicentre trial in the USA and Europe and the first reported results showed low event rates at nine months.

 


The Rebel stent system is offered in a matrix of 46 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.