Direct Flow Medical today said data from a clinical trial of its replacement heart valve showed an 80% survival rate after 2 years.
Results from Direct Flow’s Discover CE Mark trial were reported at the EuroPCR conference in Paris, the Santa Rosa, Calif.-based company said.
The 100-patient study’s survival rate was 99% after 30 days and 90% at 1 year, Direct Flow said in a press release. Eighty-five percent of patients had trace amounts or no post-procedural regurgitation and 92% had improved by more than 1 New York Heart Assn. class after 2 years (83% gained 1 NYHA class in the 1st 30 days, Direct Flow said).
"The 24-month Discover results demonstrate that the initial clinical improvements seen with the Direct Flow Medical valve translate into exceptional long-term outcomes. This next-generation TAVI device is the 1st to report such outstanding results treating an extremely sick patient population," Dr. Antonio Colombo of Milan, Italy’s Ospedale San Raffaele said in prepared remarks.
Santa Rosa, Calif.-based Direct Flow’s TAVI system 1st received CE Mark approval in the European Union in January 2013. The company said it’s enrolling patients in a pivotal investigational device exemption trial in the U.S.