FDA Clears Boston Scientific’s Promus Premier Everolimus-Eluting Coronary Stent
Stent technology launches in United States
December 2, 2013
December 2, 2013 — Boston Scientific Corporation has received U.S. Food and Drug Administration (FDA) approval for the Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System, the company's durable polymer drug-eluting stent (DES).
The technology is available immediately in the United states, with the first implantation scheduled to be performed by Martin Leon, M.D., director, Center for Interventional Vascular Therapy, Columbia University Medical Center / NewYork-Presbyterian Hospital, New York City.
"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," said Leon.
The Promus Premier Stent System offers physicians improved DES performance in treating patients with coronary artery disease (CAD) and features unique, customized platinum chromium alloy stent architecture, the Everolimus drug with a biocompatible, fluorinated co-polymer and an enhanced stent delivery system.
"After using this product for nearly a year, I am confident that Boston Scientific has advanced thin-strut technology," said John Ormiston, M.D., Mercy Angiography Auckland Hospital, Auckland, New Zealand. "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."
The Promus Premier Stent System was developed with input from interventional cardiologists and is designed to provide acute and clinical outcomes. It features high visibility, low recoil, radial strength and fracture resistance while improving axial strength and deliverability. An enhanced low-profile delivery system 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.
The Everolimus drug and PVDF-HFP stent coating have been studied in multiple randomized clinical trials demonstrating long-term safety and efficacy. The PLATINUM Clinical Trial Program demonstrated exceptional safety and efficacy of the Promus Element Stent System (platinum chromium everolimus-eluting stent) when compared to the Xience V Stent (cobalt chromium everolimus-eluting stent), including a significant reduction in bail-out stenting, providing an average of $116 in savings per procedure. Further review of the Platinum data demonstrated that the Promus Element Stent System is associated with significantly less vessel straightening in severely angulated lesions and resulted in numerically lower clinical event rates out to three years.
The Promus Premier Stent System is offered in a matrix of 94 sizes, ranging in diameter from 2.25 mm to 4 mm and lengths of 8 mm to 38 mm on both Monorail and Over-the-Wire catheter platforms. This provides physicians and their patients with a broad range of options designed to best suit their needs. The company received CE mark approval for the Promus Premier Stent System in February 2013.
For more information: www.bostonscientific.com