FDA Approves IDE to Broaden Direct Flow Medical's Pivotal SALUS Trial

April 9, 2015—Direct Flow Medical, Inc. announced that the company has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to broaden its SALUS pivotal trial evaluating the company’s transcatheter aortic valve replacement (TAVR) system.

According to Direct Flow Medical, the expansion of the SALUS trial includes the treatment of high-surgical-risk patients and the continued treatment of extreme-risk patients; a 2:1 randomization to Direct Flow system versus the Medtronic CoreValve TAVR system; a 912-patient pivotal cohort, up to 45 sites in the United States; and registries for nonfemoral access points and type 2 and 3 bicuspid valves. The previous protocol of the SALUS trial has enrolled more than 100 extreme-risk patients in a nonrandomized fashion and will continue to be followed independently.

The company noted that an earlier feasibility phase of the SALUS trial conducted in 2013 evaluated the system in 30 patients. The 30-day outcomes demonstrated a survival rate of 97%, with 100% of patients experiencing mild or less aortic regurgitation. Results also showed low procedural complications, no incidence of stroke, and a 3% rate of permanent pacing. The mean aortic gradient decreased from 44.5 mm Hg to 12.7 mm Hg at 30 days. 

According to the company, the repositionable and retrievable Direct Flow Medical TAVR system is designed to treat patients with severe aortic stenosis who are at high- or extreme-surgical risk by replacing the native aortic valve. The device minimizes the degree and frequency of aortic regurgitation by sealing the annulus and enabling complete assessment of hemodynamic performance with repositioning of the valve after full deployment. The system is designed to avoid rapid pacing of the heart during deployment and postdilatation after placement, minimizing the risk of hemodynamic instability for patients. 

The Direct Flow Medical TAVR system received CE Mark approval in January 2013 and is available commercially in Europe. The device has not been approved for sale in the United States, Canada, or Japan.

The company advised that SALUS is a prospective, randomized, multicenter, core lab adjudicated United States clinical trial. The primary endpoint of the trial is a composite of all-cause mortality and disabling stroke at 12 months. Principal investigators for the SALUS trial are Murat Tuzcu, MD, and Patrick McCarthy, MD. North. 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, “We have been working closely with the FDA since the early development of the Direct Flow Medical technology and it has been a collaborative effort with the FDA which has led to an expansion of the SALUS trial. The technology has shown outstanding performance in clinical trials and commercial settings, significantly reducing the risk of aortic regurgitation with excellent survival. We look forward to expanding the clinical use to additional centers in the United States and continuing to obtain the same strong outcomes in the pivotal trial.”