Enrollment Completed in United States Feasibility Trial of Direct Flow Medical's TAVR System

January 9, 2014—Direct Flow Medical, Inc. (Santa Rosa, CA) announced it has completed enrollment in SALUS, the United States feasibility trial of the Direct Flow Medical transcatheter aortic heart valve system. The SALUS trial is designed to assess the safety of the Direct Flow Medical system to treat patients with severe aortic stenosis who are at extreme risk for surgical aortic valve replacement.

According to the company, the SALUS trial is a nonrandomized, multicenter, core lab-adjudicated trial conducted under an investigational device exemption from the US Food and Drug Administration. Principal investigators for the SALUS Trial are Murat Tuzcu, MD, and Patrick McCarthy, MD.

Dr. Tuzcu is Vice Chairman of the Department of Cardiology at the Cleveland Clinic in Cleveland, Ohio. Dr. McCarthy is Director of the Bluhm Cardiovascular Institute and Chief of Cardiac Surgery at Northwestern Memorial Hospital in Chicago, Illinois.

In the company's press release, Dr. Tuzcu commented, “The Direct Flow Medical system has shown the ability to virtually eliminate aortic regurgitation. The completion of the SALUS trial enrollment is an important milestone towards offering this promising new technology to our patients.”

The company stated that the Direct Flow Medical valve is designed to improve aortic regurgitation outcomes. It is a fully repositionable and retrievable system that includes a distinctive, transfemorally delivered heart valve with a metal-free frame.

The Direct Flow Medical transcatheter aortic valve system addresses postprocedural aortic regurgitation by sealing the annulus and enabling complete assessment of hemodynamic performance with unlimited repositioning of the valve after full deployment. The system avoids rapid pacing of the heart during deployment and postdilatation after placement, minimizing the risk of hemodynamic instability for patients, noted the company.

According to the company, the system's polymer frame is expanded using pressurized saline and contrast for placement, assessment, and repositioning. The saline/contrast solution is easily exchanged for a quick-curing polymer that solidifies and secures the valve in place once optimal positioning is reached. The valve's double-ring design creates a tight seal around the annulus. The system is fully repositionable and retrievable up until polymer exchange. The metal-free design enables a low-profile, 18-F, fully-sheathed delivery system for all valve sizes that minimizes vascular complications and improves hemodynamic outcomes.

Direct Flow Medical advised that it is working with the US Food and Drug Administration to initiate a United States pivotal trial in 2014. The Direct Flow Medical system received CE Mark approval in January 2013 and is commercially available in Europe.

The company stated that 6-month data from the DISCOVER CE Mark trial confirm the system's ability to virtually eliminate significant aortic regurgitation. The data were presented in October at the TCT 2013: Transcatheter Cardiovascular Therapeutics conference in San Francisco, California. Through 6 months, no patient experienced moderate or severe aortic regurgitation, and there was a 96% overall survival rate, with 90% of patients in functional class I or II. The system also demonstrated a strong safety profile, with a 97% VARC-defined combined-safety rate and no incidence of major or minor strokes or myocardial infarction in the evaluable cohort between 30 days and 6 months.

The DISCOVER trial is a prospective, multicenter study of the Direct Flow Medical system conducted at nine European sites in 100 patients with severe aortic valve stenosis who required replacement of their native aortic valve but were at extreme risk for open surgical repair, noted the company.