Platinum chromium stent system approved by FDA

Boston Scientific announced that its next-generation everolimus-eluting platinum chromium coronary stent system was approved for the treatment of patients with coronary artery disease.

The PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Boston Scientific) was designed specifically for coronary stenting. It utilizes a proprietary platinum chromium platform, enabling thinner struts and enhanced visibility and making the stent more comfortable with less recoil and higher radial strength, according to the company

The FDA approval was based on the PLATINUM clinical program, which included five multicenter studies that comprised more than 1,800 patients worldwide. Clinical outcomes supported the safety and effectiveness of the PROMUS Element stent at 30 days and 9 months, with low rates of incomplete stent apposition and demonstration of acute procedural benefits. When compared with the PROMUS stent for the treatment of de novo coronary artery lesions, the PROMUS Element stent demonstrated clinical noninferiority and procedural benefits of reduced rates of geographic miss and unplanned stenting, according to previously released data

“The clinical results we observed with the PROMUS Element stent compared with the PROMUS stent in the large-scale PLATINUM Workhorse trial, including extremely low rates of stent thrombosis, demonstrate that excellent clinical outcomes are achieved with this novel coronary stent system,” Gregg W. Stone, MD, professor of medicine and director of research and education at the Center for Interventional Vascular Therapy at Columbia University Medical Center/New York-Presbyterian Hospital, said in a Boston Scientific press release.

Currently, the PROMUS Element stent system is offered in a matrix of 74 sizes, ranging in diameter from 2.25 mm to 4 mm and lengths of 8 mm to 32 mm. Additional stent lengths of 32 mm and 38 mm are expected to be available in mid-2012.

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