News | Heart Valve Technology | October 22, 2015

Post-Market Study Confirms Positive Outcomes for Direct Flow Medical TAVR System

Findings corroborate low incidence of paravalvular leak found in pre-market DISCOVER CE Mark trial

Direct Flow Medical TAVR System, DISCOVER post-market study, real-world results, TCT 2015

Image courtesy of Direct Flow Medical Inc.

October 22, 2015 — Direct Flow Medical Inc. announced one-year outcomes from the DISCOVER post-market study that demonstrate excellent real-world results for the Direct Flow Medical Transcatheter Aortic Valve System. The data were presented last week at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting by Federico De Marco, M.D., from the Policlinico San Donato in Milan, Italy.

The 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 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 New York Heart Association (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 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.”
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.

The fully repositionable and retrievable Direct Flow Medical system is designed to treat patients with severe aortic stenosis, while reducing the risk of post-procedural aortic regurgitation, a strong predictor of long-term mortality. The system addresses this clinical concern by sealing the annulus and enabling complete assessment of hemodynamic performance with unlimited “in situ” repositioning of the valve after full deployment. The system includes a distinctive heart valve with a metal-free frame, delivered transfemorally via the same flexible delivery system for all sizes (23mm, 25mm, 27mm and 29mm).

The system received the CE Mark in January 2013 for the treatment of patients with aortic stenosis who are at extreme surgical risk. It is currently available commercially in Europe and is being studied in a pivotal trial that is currently enrolling in the United States.

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