Registry Data Supports Direct Flow’s Promise

It’s all sounding good for Direct Flow Medical’s innovative transcatheter aortic valve offering as more clinical evidence, this time from registry data, suggest it’s living up to its promise.

Background

Not content with solid two year data from its DISCOVER CE Mark trial, it seems registry data also demonstrate excellent real world results for the Direct Flow Medical Transcatheter Aortic Valve System. The data were presented yesterday at the EuroPCR conference in Paris, France by Christoph C. K. Naber, MD, PHD, from the Contilia Heart Center in Essen, Germany. The DISCOVER post-market study is a prospective, multicenter, all-comers registry of up to 1,000 patients conducted at up to 75 European sites to evaluate the outcomes of the Direct Flow Medical valve on patients with severe aortic stenosis in routine clinical practice.

The 30-day data on 250 all-comer patients from the DISCOVER post-market study showed a 98 percent survival rate, which emulated the 99 percent survival rate previously reported at 30 days from the DISCOVER CE Mark Trial. The average age of patients in the trial was 82.5 years, with a mean logistic euroSCORE of 18.3 percent.

Most significantly, given the device’s design claims, mild or less post-procedural aortic regurgitation was achieved in 97 percent of patients, with 80 percent of patients experiencing none to trace aortic regurgitation.

The stroke rate and incidence of myocardial infarction within 30 days was low, at two percent and .8 percent, respectively. A low major vascular complications rate of four percent demonstrates the system’s flexibility and trackability even in tortuous anatomy. No patient required rapid pacing during deployment or post-dilatation following deployment, minimizing the risk of hemodynamic stress. In addition, no patient required more than one valve, eliminating the need for a valve-in-valve procedure and the associated negative outcomes observed with non-retrievable transcatheter aortic valves.

Investigator comments

“Treating patients with the Direct Flow Medical valve in a real-world setting and getting the same consistent results seen in the clinical trial shows outstanding performance, “ said Dr. Naber. “In daily practice we are faced with patients that are normally excluded by protocol from clinical studies, but these patients need treatment, as well. It is reassuring to know that we can reproduce the same results in challenging clinical scenarios with this valve.”

Source: Direct Flow Medical, Inc.

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