News | Heart Valve Technology | May 20, 2016

Direct Flow Medical Announces DISCOVER Trial Three-Year Results

Retrievable TAVR device shows excellent cardiac mortality, paravalvular leak rate and NYHA functional classification outcomes

Direct Flow Medical, TAVR device, DISCOVER trial, three-year results, EuroPCR 2016

May 20, 2016 — Direct Flow Medical Inc. presented three-year results from its prospective, multicenter DISCOVER Trial at the EuroPCR meeting in Paris.

According to the company, the Direct Flow Medical transcatheter aortic valve replacement (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 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 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; and
  • 96 percent NYHA Class I or II status.

Direct Flow Medical is sponsoring 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.

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