FDA Approval for Boston’s Promus Premier™ “Next Generation” Drug Stent

Boston Scientific Corporation has received US FDA approval for the Promus PREMIER™ Everolimus-Eluting Platinum Chromium Coronary Stent System, which it describes as its next-generation durable polymer drug-eluting stent (DES).

Background

Back in February 2013 we reported the news that Boston Scientific had received CE Mark approval for the Promus PREMIER Stent System. Now the FDA has followed suit.

In a press release, Boston Scientific says the Promus PREMIER Stent System 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.

The stent itself features unique customized platinum chromium alloy stent architecture, combined with the market-leading Everolimus drug, a biocompatible, fluorinated co-polymer and an enhanced low-profile stent delivery system. A shorter, more visible tip, a dual-layer balloon and a Bi-Segment™ inner lumen catheter are all designed to facilitate precise stent delivery across challenging lesions.

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.

Physician comments

The technology will now be made immediately available in the US, 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.”

“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.”

Company comments

“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.”

Source: Boston Scientific Corporation, PR Newswire

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