Boston Scientific’s Rebel coronary stent system gets approval from FDA

22 July 2014 (Last Updated July 22nd, 2014 18:30)

The US Food and Drug Administration (FDA) has approved US-based Boston Scientific's Rebel platinum chromium coronary stent system used for treatment of coronary artery disease (CAD).

The US Food and Drug Administration (FDA) has approved US-based Boston Scientific's Rebel platinum chromium coronary stent system used for treatment of coronary artery disease (CAD).

The Rebel stent system is the company's latest generation bare-metal stent and expands its family of stents featuring platinum chromium alloy and a customised stent architecture design.

Boston Scientific said that the Rebel stent provides the identical stent platform as the Promus Premier drug-eluting stent but without the Everolimus drug.

The system is available in a matrix of 46 sizes, ranging in diameter from 2.25mm-4.50mm and lengths of 8mm-32mm on a Monorail platform.

"The stent system provides better visibility, low-recoil, radial strength and fracture-resistance, while improving axial strength and deliverability."

In February, the company received CE Mark for the Rebel stent system.

John Wang from Medstar Union Memorial Hospital said: "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.

"In addition, the platinum chromium architecture provides great radial strength with low recoil, which is particularly important in patients receiving bare-metal stents."

According to Boston Scientific, the stent system provides better visibility, low-recoil, radial strength and fracture-resistance, while improving axial strength and deliverability.

The improved 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.

Boston Scientific president of Interventional Cardiology Kevin Ballinger said: "Boston Scientific is committed to developing the best treatment options for all patients with coronary artery disease.

"Launching the Rebel stent system in the US is another important step to ensure that we offer physicians the most differentiated and broadest product portfolio possible."

The approval is based on data from the Omega clinical trial assessing the stent system at the Cardiovascular Research Technologies conference in Washington.

Omega is a single arm, multi-centre trial in the US and Europe and the first reported results showed low event rates at nine months.