The FDA has given Boston Scientific the green light to market its next-generation durable polymer drug-eluting stent in the U.S.
The agency approved the Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System for treating patients with coronary artery disease. According to the Natick, Mass.-based company, the stent provides a platinum chromium alloy stent architecture, everolimus drug and a biocompatible, fluorinated co-polymer coating.
The stent system offers a low-profile delivery system with a shorter tip, a dual-layer balloon and an inner lumen catheter designed to facilitate stent delivery.
The Promus stent has been evaluated in several studies. At the 2013 Transcatheter Cardiovascular Therapeutics scientific session in San Francisco, for instance, a clinical trial designed to compare Promus Element and Resolute Integrity (Medtronic) stents found them to be comparable for safety and efficacy.
The Promus Premier Stent System is offered in a matrix of sizes ranging in diameter from 2.25 mm to 4 mm and lengths of 8 mm to 38 mm. The Promus Premier stent received CE Mark approval earlier this year.