Direct Flow Medical® TAVI System Sees Strong Six Month Data Presented at TCT2013

No stranger to our pages, transcatheter heart valve innovator, Direct Flow Medical®, Inc., has seen six month implant data presented at the TCT2013 congress, from the now fully-enrolled DISCOVER CE Mark Trial. A company press release says the results continue to affirm the excellent outcomes and strong safety profile of the company’s Transcatheter Aortic Valve System.

Background

The Direct Flow Medical Transcatheter Aortic Valve System is another design that could reasonably be described as next generation. The device’s clever double ring arrangement is designed to enable in-situ hemodynamic assessment during the procedure, as well as unlimited repositioning until optimal valve placement is achieved. The objective is to minimize the risk of aortic regurgitation, a key predictor of long-term mortality following TAVI procedures.

Data from the DISCOVER trial, which were presented on Monday at the Transcatheter Cardiovascular Therapeutics (TCT) conference, demonstrated sustained results at six months, with 96 percent freedom from all-cause mortality and no incidence of moderate or severe post-procedural aortic regurgitation.

The DISCOVER Trial is a prospective, multi-center study conducted at nine European sites in 100 patients with severe aortic valve stenosis who require replacement of their native aortic valve but are at extreme risk for open surgical repair.

The results from the DISCOVER Trial confirm the system’s ability to virtually eliminate aortic regurgitation, with no patient experiencing moderate or severe aortic regurgitation at six months. Patients were 96% free from all-cause mortality. Additionally, the mean gradient of 13.0mmHg as measured by echocardiography at six months demonstrates that the Direct Flow Medical valve can significantly reduce, and maintain, low transvalvular gradients over time.

At six months, 78.6 percent of patients improved by one or more New York Heart Association (NYHA) functional classes and 90 percent of patients were classified as NYHA Class I or II.

Investigator comments

“These data show that the excellent results obtained with the Direct Flow Medical system are sustainable over time,” said Principal Investigator Joachim Schofer, M.D., from the Medical Care Center, Hamburg, Germany. “The Direct Flow Medical system is able to virtually eliminate aortic regurgitation with outstanding patient safety. These results continue to be unprecedented for a TAVI device.”

Company comments

“We have developed this true next generation technology over several years and now have core lab Clinical Events Committee (CEC) and Data Monitoring Committee (DMC)-adjudicated outcomes to prove the performance of this device. The results demonstrate that patients treated with the Direct Flow Medical system show a marked improvement in NYHA Class and excellent survival through six months,” said Bernard Lyons, Chief Executive Officer of Direct Flow Medical.

“The European-based DISCOVER study has paved the way for the U.S. SALUS I IDE Trial, which initiated enrollment last month,” said Lyons. “We are also working closely with the FDA on the development of the SALUS II pivotal trial and look forwarding to commencement in early 2014.”

Regulatory status

The Direct Flow Medical system received the CE Mark in January 2013 and is currently commercially available in Europe.

Source: Direct Flow Medical, Inc.