Boston Scientific's PROMUS Element Stent receives FDA approval
The FDA has approved Boston Scientific's PROMUS Element plus everolimus-eluting platinum chromium coronary stent system, the company's next-generation drug-eluting stent (DES) technology. The PROMUS Element Stent, designed to provide physicians improved DES performance in treating patients with coronary artery disease, is built on an innovative platinum chromium (PtCr) platform with
the market-leading everolimus drug. The company plans to begin marketing
the product in the U.S. immediately.
The PROMUS Element Stent uses a proprietary PtCr alloy designed specifically for coronary stenting, which enables thinner struts and enhanced visibility. The innovative design offers a more conformable stent with less recoil and higher radial strength. It employs an advanced low-profile delivery system featuring a dual-layer balloon and Bi-Segment inner lumen catheter designed to facilitate precise stent delivery across challenging lesions. The everolimus drug and fluorinated copolymer stent coating have been studied in multiple randomized clinical trials and 'real-world' registries, demonstrating excellent long-term
safety and efficacy.