Direct Flow Medical Announces DISCOVER Trial Three-Year Results
SANTA ROSA, Calif. and Paris – May 20, 2016 – Direct Flow Medical, Inc., a medical device company developing and commercializing transcatheter heart valve therapy products to treat structural heart disease, presented three-year results from its prospective, multicenter DISCOVER Trial at the EuroPCR meeting in Paris.
The Direct Flow Medical transcatheter aortic valve (TAVR) system, with more than 2,700 implants and excellent published clinical results including low rates of paravalvular leak, pacemaker implant, and mortality, is the only non-metallic, conformable transcatheter aortic valve that can be functionally assessed, repositioned, and retrieved prior to final implant.
The DISCOVER prospective, randomized trial is evaluating 100 subjects treated with the Direct Flow Medical TAVR system at nine clinical centers in four European countries. Federico De Marco, M.D., PhD, IRCCS Policlinico San Donato, Milan presented the three-year results at a session on new generation TAVR devices during the annual EuroPCR meeting in Paris.Data at three years show excellent and durable results of the Direct Flow Medical TAVR system including high patient survivability and best-in-class paravalvular leak (PVL) performance. In addition, most patients’New York Heart Association (NYHA) functional classification was I or II.
Specific three-year DISCOVER Trial results include:
- 82.6% freedom from cardiac mortality
- 100% mild or less PVL rate; 75% none/trace PVL rate
- 96%NYHA Class I or II status
Dan Lemaitre, President and CEO commented, “The DISCOVER Trial three-year results show excellent and sustained outcomes for patients treated with the Direct Flow Medical TAVR system.” He continued, “Clinical evidence from the DISCOVER Trial demonstrate the Direct Flow Medical TAVR system provides physicians and patients with a unique transcatheter aortic valve solution with distinguished short and midterm clinical results.”
About Direct Flow Medical, Inc.
Direct Flow Medical, Inc. is a privately-held medical device company developing and commercializing novel transcatheter heart valve therapy products to treat structural heart disease.
The company sponsors the SALUS Pivotal Trial in the U.S.to investigate the Direct Flow Medical Transcatheter Aortic Valve System for treating high and extreme risk severe symptomatic aortic stenosis. The system is commercially available in Europe for treating extreme surgical risk aortic stenosis.
Direct Flow Medical, Inc.
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