Real-World registry data presented at this week’s Transcatheter Cardiovascular Therapeutics (TCT) annual meeting confirm pre-market promise of excellent world results for the Direct Flow Medical Transcatheter Aortic Valve System.
Maker of perhaps the most novel transcatheter heart valve in circulation today, Direct Flow Medical®, Inc., has announced one-year outcomes from the DISCOVER post-market study into its system. The Data were presented at the TCT annual meeting during the Award-Winning Oral Abstracts session, by Federico De Marco, MD, from the Policlinico San Donato in Milan, Italy.
The DISCOVER post-market study is a prospective, multi-center registry to evaluate the outcomes of the Direct Flow Medical valve in patients with severe aortic stenosis in routine clinical practice. One-year commercial data on 200 consecutive patients showed an 82 percent freedom from all-cause mortality and a 90 percent freedom from cardiovascular mortality, similar to the 90 percent survival rate at one year previously reported from the ground-breaking DISCOVER CE Mark trial. The average age of patients in the trial was 83 years with a mean logistic EuroScore of 18.2 percent.
In the study, 95 percent of patients experienced mild or less paravalvular regurgitation, with 85 percent of patients showing no or trace paravalvular leak. Clinical improvement was sustained over time, with 84 percent of patients in NYHA functional class I or II.
“The consistency between valve performance in this real world, post-market registry and the outstanding results from the DISCOVER pre-market trial is impressive,” said Dr. De Marco. “Overall, the data demonstrate excellent results and low complications. In particular, I expect the consistently low incidence of mild or higher paravalvular leak to translate into improved long-term outcomes for these patients.”
Source: Direct Flow Medical, Inc.