Two coronary stent companies with very different treatment focuses heralded promising clinical advances in conjunction with the Transcatheter Cardiovascular Therapeutics conference in Miami on Oct. 22.
Ireland's Cappella Medical Devices says it has generated positive long-term results from 399 patients in the United Kingdom, Germany and Italy who were treated with the company's Sideguard stent delivery technology for coronary bifurcation disease. Major adverse cardiac events reached 3.7% at the 30-day follow up, 7.1% after six months and 10.2% at the 12-month follow up, which the company said compared with existing standards of care.
Sideguard uses a self-expanding nitinol stent that is delivered with a split-sheathed balloon system that helps preserve the sidebranch of diseased coronary arteries, the company explains. It is CE marked in Europe and also approved in South America, India and Canada.
Svelte Medical Systems of New Providence, NJ, by contrast, is just getting ready for a pivotal study for its coronary stent integrated delivery system. The company disclosed that the FDA granted an investigational device exemption to proceed with a 370-patient trial at as many as 30 U.S. sites. Plans call for testing safety and effectiveness of the company's wire/balloon-stent combination system that's designed to deliver stents more quickly and safely compared to existing procedures.
Coronary stents are ubiquitous these days, and the TCT conference is designed to share advances among the more innovative companies in the sector.
- read the Cappella news
- here's the Svelte release
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