Business Wire05.23.16
Direct Flow Medical Inc., a company developing and commercializing transcatheter heart valve therapy products for structural heart disease treatment, has 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., Ph.D., IRCCS Policlinico San Donato, Milan, presented the three-year results at a session on new generation TAVR devices during the recent EuroPCR meeting in Paris, France.
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:
“The DISCOVER Trial three-year results show excellent and sustained outcomes for patients treated with the Direct Flow Medical TAVR system,” said Dan Lemaitre, Direct Flow Medical president and CEO. “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.”
Direct Flow Medical, Inc. is a privately-held firm based in Santa Rosa, Calif. The company sponsors the SALUS Pivotal Trial in the United States 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.
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., Ph.D., IRCCS Policlinico San Donato, Milan, presented the three-year results at a session on new generation TAVR devices during the recent EuroPCR meeting in Paris, France.
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 percent freedom from cardiac mortality
- 100 percent mild or less PVL rate; 75 percent none/trace PVL rate
- 96 percent NYHA Class I or II status
“The DISCOVER Trial three-year results show excellent and sustained outcomes for patients treated with the Direct Flow Medical TAVR system,” said Dan Lemaitre, Direct Flow Medical president and CEO. “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.”
Direct Flow Medical, Inc. is a privately-held firm based in Santa Rosa, Calif. The company sponsors the SALUS Pivotal Trial in the United States 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.