Trial Results Announced for Promus Element Stent at TCT


September 23, 2010

September 23, 2010 - Results from a study evaluating the safety and clinical efficacy of the Promus Element everolimus-eluting coronary stent will be released at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington, D.C.

The Platinum QCA study evaluated Boston Scientific’s Promus Element everolimus-eluting platinum chromium coronary stent. Results provided 30-day and nine-month clinical outcomes and nine-month quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS) data. Analysis was presented by Ian Meredith, MBBS, Ph.D., director of cardiology at the Monash Medical Centre in Melbourne, Australia and principal investigator of the study.

"The nine-month angiographic and IVUS data from the Platinum QCA study are impressive and show the acute performance advantages of the platinum chromium Promus Element Stent," Meredith said. "With the same drug and polymer loading and comparable release kinetics as the Promus Stent, the Promus Element Stent achieved similar late loss and significantly better stent apposition. These results give me great confidence in the transferability of the everolimus drug and its proven clinical outcomes, as well as the potential benefits of the new platinum chromium alloy."

The stent features a platinum chromium (PtCr) alloy, which helps offer greater radial strength and flexibility while reducing stent recoil. The geometry helps create consistent lesion coverage and drug distribution while improving deliverability. The higher density PtCr alloy provides superior visibility while permitting thinner struts compared to prior-generation stents.

Of the 100 patients studied, one patient experienced a peri-procedural stent thrombosis and TLR. No additional major clinical events were reported from 31 days to nine months.

In the United States, the Promus Element system is an investigational device and not available for sale.

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