Boston Scientific Corp. (BSX) said the U.S. Food and Drug Administration, or FDA, has provided the company regulatory approval of 32 mm and 38 mm lengths for the PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System, the company's next-generation drug-eluting stent, or DES, technology.
The PROMUS Element Stent is built on an innovative platinum chromium platform with the market-leading everolimus drug and is designed to provide physicians exceptional DES performance in treating patients with coronary artery disease.
The company noted that the 32 and 38 mm lengths of the PROMUS Element Plus Stent System are immediately available in the U.S. According to Boston Scientific, clinical data support the safety and efficacy of the PROMUS Element Stent in patients with long coronary lesions. As part of the comprehensive PLATINUM Clinical Trial program, the one year data from the PLATINUM Long Lesion Trial demonstrated low rates of revascularization while reporting no cardiac death, myocardial infarction or stent thrombosis in patients with long coronary lesions.
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