FDA Approves Boston Scientific's Bare-Metal Rebel PtCr Coronary Stent System

July 21, 2014—Boston Scientific Corporation announced that the bare-metal Rebel platinum chromium (PtCr) coronary stent system has received US Food and Drug Administration approval for the treatment of coronary artery disease. The Rebel system is offered in a matrix of 46 sizes, ranging in diameter from 2.25 mm to 4.5 mm and including lengths of 8 mm to 32 mm on a Monorail platform. The company announced European CE Mark approval for the Rebel stent system earlier this year.

According to Boston Scientific, the Rebel PtCr device offers the same stent platform as the company’s Promus Premier drug-eluting stent (DES). The Rebel system is designed to provide low recoil and excellent visibility, radial strength, fracture resistance, axial strength, and deliverability. The device’s low-profile delivery system also features a short, visible tip; a dual-layer balloon; and a Bi-Segment inner lumen catheter designed to facilitate precise stent delivery across challenging lesions.

In the company’s press release, John C. Wang, MD, commented, “Bare-metal stents are an important part of our practice, as not every patient can receive a DES.  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. In addition, the PtCr architecture provides great radial strength with low recoil, which is particularly important in patients receiving bare-metal stents.”

Dr. Wang, who is from Medstar Union Memorial Hospital in Baltimore, Maryland, presented data from the OMEGA clinical trial evaluating the Rebel stent system at the Cardiovascular Research Technologies conference in February in Washington, DC. OMEGA is a single-arm, multicenter trial in the United States and Europe, and the first reported results showed low event rates at 9 months, advised Boston Scientific.