Direct Flow Medical, 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."