FDA Approves Boston Scientific's Promus Premier DES

November 25, 2013—Boston Scientific Corporation (Natick, MA) announced US Food and Drug Administration (FDA) approval for the Promus Premier everolimus-eluting platinum chromium coronary stent system, the company's next-generation durable polymer drug-eluting stent (DES). The company received European CE Mark approval for the Promus Premier stent system in February 2013.

The company advised that the technology is available immediately in the United States, with the first implantation scheduled to be performed by Martin Leon, MD. Dr. Leon is Director of the Center for Interventional Vascular Therapy at Columbia University Medical Center/New York-Presbyterian Hospital in New York City. 

In Boston Scientific's press release, Dr. Leon commented, “It's very rewarding, professionally, to be the first to provide this new DES therapy to my patients. Perhaps the most impressive benefit of the Promus Premier stent system is its unparalleled visibility, which, combined with enhanced customized stent architecture, leads to an advance in currently available durable polymer DES.”

Boston Scientific is offering the Promus Premier stent system in a matrix of 94 sizes, ranging in diameter from 2.25 to 4 mm and lengths of 8 to 38 mm on both monorail and over-the-wire catheter platforms. 

Boston Scientific stated that the new device offers excellent visibility, low recoil, exceptional radial strength and fracture resistance, and improved axial strength and deliverability. The system features a customized platinum chromium alloy stent architecture, the everolimus drug with a biocompatible fluorinated copolymer, and an enhanced stent delivery system. The low-profile delivery system features a shorter and more visible tip, a dual-layer balloon, and the company's Bi-Segment inner lumen catheter designed to facilitate precise stent delivery across challenging lesions.

“After using this product for nearly a year, I am confident that Boston Scientific has advanced thin-strut technology,” commented John Ormiston, MD, in Boston Scientific's announcement. Dr. Ormiston, who is from Mercy Angiography Auckland Hospital in Auckland, New Zealand, continued, “The customized platinum chromium stent architecture maintains excellent radial strength and flexibility, along with optimal radiopacity, while offering improved longitudinal strength. In addition, the enhanced stent delivery system contributes to superior stent deliverability.”