Boston Scientific obtains FDA clearance for next-generation Promus Premier coronary stent

25 November 2013 (Last Updated November 25th, 2013 18:30)

Boston Scientific has obtained 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).

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Boston Scientific has obtained 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 Promus Premier stent system is designed to provide physicians improved DES performance in treating patients with coronary artery disease.

It is reportedly the only platform to feature a customised platinum chromium (PtCr) stent architecture, the market-leading Everolimus drug coating and fluorinated co-polymer, and an enhanced stent delivery system.

The technology is available immediately in the US, with the first implantation scheduled to be performed by Dr Martin Leon, director of the Center for Interventional Vascular Therapy at Columbia University Medical Center / New York-Presbyterian Hospital, New York.

"Perhaps the most impressive benefit of the Promus Premier stent system is its unparalleled visibility, which combined with enhanced customised stent architecture, leads to an advance in currently available durable polymer DES," Dr Leon said.

The customised platinum chromium stent architecture maintains the superior visibility, exceptional radial strength and fracture resistance, while offering improved axial strength and deliverability.

In addition, the enhanced stent delivery system contributes to superior stent deliverability.

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 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.

"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."

The Everolimus drug and PVDF-HFP stent coating have been studied in multiple randomised clinical trials demonstrating long-term safety and efficacy.

The Platinum clinical trial programme demonstrated exceptional safety and efficacy of the Promus element stent system (platinum chromium everolimus-eluting stent) when compared with Abbott Laboratories' Xience V Stent (cobalt chromium everolimus-eluting stent), including a significant reduction in bail-out stenting, saving an average of $116 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.

Boston Scientific Interventional Cardiology president Kevin Ballinger said the Promus Premier stent system reflects company's commitment to DES technology and providing interventional cardiologists with a 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 said.

The Promus Premier stent system is offered in a matrix of sizes ranging in diameter from 2.25mm-4mm and lengths of 8mm-38mm on both Monorail and Over-the-Wire catheter platforms.

The Promus Premier stent received CE Mark approval earlier this year.


Image: Boston Scientific receives FDA approval for the Promus Premier everolimus-eluting platinum chromium coronary stent system. Photo: courtesy of Boston Scientific Corporation.