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Medical Devices / Regulatory Affairs / Submissions and Approvals

FDA Green Lights BSX’s Promus Premier Stent

Nov. 27, 2013

Boston Scientific says it will market its new Promus Premier Everolimus-eluting chromium stent system immediately, with the first implantation scheduled for Columbia University Medical Center/New York-Presbyterian Hospital in New York City. The FDA approved the company’s supplemental PMA on Nov. 21.

The device, developed with input from cardiologists, contains a customized chromium alloy architecture, the “market-leading” everolimus drug with a biocompatible, fluorinated copolymer, and an enhanced stent delivery system, according to BSX.

The chromium alloy gives the stent strength and flexibility, said BSX spokeswoman Denise Kaigler. The stent also provides radial strength and fracture resistance with a shorter, easier-to-see tip, a dual-layer balloon and a bi-segment inner lumen catheter designed to allow surgeons to more effectively deliver the stent across lesions in blood vessels, she said.

Randomized clinical trials showed that the drug and stent coating have “exceptional safety and efficacy,” with a meaningful reduction in bail-out stenting and $116 saved per procedure.

The stent comes in 94 sizes, ranging from 2.25 mm to 4 mm in diameter and 8mm to 38 mm in length.

The stent already has CE Mark approval in the EU. BSX expects approval in China and Japan in the near future, Kaigler said. — Lena Freund

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