IDE Approval Granted for U.S. Pivotal Trial of Direct Flow Medical TAVR Device
May 30, 2014 — Direct Flow Medical has received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to initiate the pivotal phase of the SALUS trial. The SALUS trial is a prospective, non-randomized, multicenter, core lab adjudicated clinical trial, evaluating the Direct Flow Medical transcatheter aortic valve system at up to 30 sites.
The fully repositionable and retrievable Direct Flow Medical system is designed to treat patients with severe aortic stenosis who are at extreme surgical risk, 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 repositioning of the valve after full deployment. The system avoids rapid pacing of the heart during deployment and post-dilatation following placement, minimizing the risk of hemodynamic instability for patients.
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, M.D., vice chairman of the department of cardiology, Cleveland Clinic, and Patrick McCarthy, M.D., director of the Bluhm Cardiovascular Institute and chief of cardiac surgery, Northwestern Memorial Hospital.
An earlier feasibility phase of the SALUS trial conducted in 2013 evaluated the system in 30 patients. The 30-day outcomes were presented by Tuzcu at the 2014 EuroPCR conference, demonstrating a survival rate of 97 percent, low procedural complications, no incidence of stroke, a three percent rate of permanent pacing and 100 percent of patients with mild or less aortic regurgitation. The mean aortic gradient decreased from 44.5 mmHg to 12.7 mmHg at 30 days.
“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, which has led to an approval to start the pivotal phase of the SALUS trial. The technology has shown outstanding performance in clinical trial and commercial settings, significantly reducing the risk of aortic regurgitation and improving patient survival. We look forward to expanding the clinical use to additional centers in the U.S. and continuing to obtain the same strong outcomes in the pivotal trial,” said Charles Davidson, M.D., chief medical officer of Direct Flow Medical.
The Direct Flow Medical system received the CE mark in January 2013 and is currently available commercially in Europe.
For more information: www.directflowmedical.com