US-based Boston Scientific has received CE Mark approval for its next-generation bare metal stent, REBEL platinum chromium coronary stent system, designed to treat coronary artery disease (CAD).
The REBEL stent system offers physicians the same platform as the Promus PREMIER drug eluting stent (DES), but without the Everolimus drug.
The customised platinum chromium alloy stent features unparalleled visibility, low recoil, exceptional radial strength and fracture resistance, while improving axial strength and deliverability.
The enhanced low-profile delivery system features a shorter, more visible tip, a unique dual-layer balloon and a Bi-Segment inner lumen catheter, which provides an appropriate level of pushability and flexibility to create enhanced deliverability.
Investigator for the OMEGA clinical trial professor Dr Didier Carrie said: "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."
OMEGA is a single-arm, multi-centre trial designed to assess the platinum chromium bare metal stent system in the US and Europe. The trial data is expected to support the FDA regulatory submission.
In February, Dr John C Wang of Medstar Union Memorial Hospital, Baltimore, Maryland, presented the trial data from OMEGA at the Cardiovascular Research Technologies conference in Washington, DC.
Boston Scientific interventional cardiology president Kevin Ballinger said the company is committed to advancing cardiology and providing treatment options for all patients with CAD.
"This includes innovating and improving the performance of bare metal stent technology to enhance patient outcomes," Ballinger said.
The REBEL stent system is currently available on a Monorail platform in a matrix of 48 sizes, ranging in diameter from 2.25mm to 4.50mm and lengths of 8mm to 32mm. This provides physicians with a range of options designed to best suit patient needs.
According to the company, bare metal stents continue to play a vital role in the treatment of CAD and represent a significant portion of the global stent market.
The REBEL stent system is currently an investigational device and not available for sale in the US.
Image: Boston Scientific's corporate headquarters in Natick, Massachusetts. Photo: courtesy of Boston Scientific Corp.