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Boston Scientific obtains FDA approval for Promus Premier coronary stent system

US-based Boston Scientific has obtained an approval from the US Food and Drug Administration (FDA) for its Promus PREMIER everolimus-eluting platinum chromium coronary stent system.

The company’s next-generation durable polymer drug-eluting stent Promus PREMIER stent system features customized platinum chromium alloy stent architecture, Everolimus drug with a biocompatible, fluorinated co-polymer and an enhanced stent delivery system.

Promus PREMIER stent system offers a low-profile delivery system with a shorter tip, a dual-layer balloon and a Bi-Segment inner lumen catheter designed to facilitate stent delivery across challenging lesions.

The stent system is available in a matrix of 94 sizes, ranging in diameter from 2.25mm to 4.00mm and lengths of 8mm to 38mm on both Monorail and Over-the-Wire catheter platforms.

It provides unparalleled visibility, low recoil, exceptional radial strength and fracture resistance, while improving axial strength and deliverability.

Promus PREMIER offers physicians improved DES performance in treating coronary artery disease patients.

Boston Scientific Interventional Cardiology president Kevin Ballinger noted the Promus PREMIER stent system reflects the company’s commitment to DES technology and to providing interventional cardiologists with the most complete portfolio of clinical solutions.

"Through ongoing collaboration with physicians, we expect to continue to innovate and build on our industry-leading platinum chromium platform," Ballinger added.

The stent system is immediately available in the US. First implantation of the system is scheduled to be performed at the Columbia University Medical Center / New York-Presbyterian Hospital, New York City.

Boston Scientific has obtained CE Mark approval for the Promus PREMIER stent system in February 2013.