Direct Flow Medical presented three-year results from its prospective, multicentre DISCOVER Trial at the 2016 EuroPCR meeting in Paris.
The DISCOVER prospective, randomised trial is evaluating 100 subjects treated with the Direct Flow Medical TAVR system at nine clinical centers in four European countries. Federico De Marco, Policlinico San Donato, Milan, Italy, 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:
- 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 chief executive officer comments, “The DISCOVER trial three-year results show excellent and sustained outcomes for patients treated with the Direct Flow Medical TAVR system.” He continues, “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.”