Boston Scientific Receives FDA Approval for Coronary Stent System
Advanced Stent Technology to Launch Immediately in the United States
Continuing to advance leading drug-eluting stent (DES) technology, 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 next-generation durable polymer drug-eluting stent (DES).
The technology is available immediately in the U.S., with the first implantation scheduled to be performed by Martin Leon, M.D., director, Center for Interventional Vascular Therapy at Columbia University Medical Center / New York-Presbyterian Hospital, New York City.
"It's very rewarding, professionally, to be the first to provide this new DES therapy to my patients," said Leon. "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."
The Promus PREMIER Stent System offers physicians improved DES performance in treating patients with coronary artery disease, and features unique customized platinum chromium alloy stent architecture, the market-leading 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."
Coronary artery disease is a narrowing of blood vessels that supply blood and oxygen to the heart. Patients with coronary artery disease may experience pain, shortness of breath and fatigue. They may also be at risk for a heart attack. One treatment option is the placement of a stent in the artery to help keep it open and allow the blood to flow more freely.
The Promus PREMIER Stent System was developed with extensive input from interventional cardiologists and is designed to provide best in class acute and clinical outcomes. It features unparalleled visibility, low recoil, exceptional 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.1 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 reflects our commitment to DES technology and to providing interventional cardiologists with the most complete portfolio of clinical solutions," said Kevin Ballinger, president, Interventional Cardiology, Boston Scientific. "Through ongoing collaboration with physicians, we expect to continue to innovate and build on our industry-leading platinum chromium platform."
The Promus PREMIER Stent System is offered in a matrix of 94 sizes, ranging in diameter from 2.25 mm to 4.00 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.
1 Hale C, Stern S, Kansal A, et al. Adapted from: Economic Analysis of Stent Platforms: Cost-Effectiveness of the Platinum Chromium PROMUS Element™ compared to Cobalt Chromium PROMUS™/Xience V™ Everolimus-Eluting Stents. Presented at the International Society of Pharmaeconomics and Outcomes Research (ISPOR) 2013 Meeting.