Boston Scientific (NYSE:BSX) unveiled new study results at the EuroPCR meeting in Paris today, touting the "excellent" safety and effectiveness of its Promus Element drug-eluting stents in small coronary vessels.
"The Platinum Small Vessel data continue to demonstrate very low revascularization rates, with no myocardial infarction or stent thrombosis through 2 years of follow up in patients treated with the 2.25 mm Promus Element stent," co-principal investigator Ian Meredith said in prepared remarks. "These long-term results are impressive, especially considering the small vessel diameters that were evaluated in this study."
Boston Scientific won FDA approval for the next-generation Promus Element stent for small vessels about a year ago, launching immediately in the U.S.
The stents are designed for use in patients with small blood vessels, who account for about 10% of percutaneous coronary interventions, according to the company. The stent uses a proprietary platinum-chromium alloy and elutes the drug everolimus.
In the company’s Platinum Workhorse Small Vessel trial, researchers found a 2.4% rate of target lesion failure at 1 year and 4.7% at 2 years, according to a press release. The study also showed a 2.5% rate of target lesion revascularization, 2.3% rate of cardiac death, no myocardial infractions and no definite or probably incidents of stent thrombosis.
The Promus Element stent, among the thinnest on the market, got some attention late last year when the FDA required Boston Scientific to include the potential for stent “shrinkage” in the device’s labeling.