July 22, 2015 Direct Flow Medical Inc. received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) in April to broaden its SALUS Trial. The expansion includes the addition of high-risk patients and randomization against a commercial device, the Medtronic CoreValve.
The SALUS Trial is a prospective, randomized, multi-center, core lab adjudicated U.S. clinical trial, evaluating the Direct Flow Medical Transcatheter Aortic Valve System. 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.
The expansion of the SALUS Trial includes the following changes:
- Treatment of high surgical risk patients and continued treatment of extreme risk patients;
- 2:1 randomization to Medtronic CoreValve;
- 912 subject pivotal cohort;
- Up to 45 sites in the U.S.; and
- Registries for non-femoral access points and type 2 and 3 bicuspid valves.
The repositionable and retrievable Direct Flow Medical system is designed to treat patients with severe aortic stenosis who are at high or extreme surgical risk by replacing the native aortic valve, while minimizing the degree and frequency of aortic regurgitation (AR). AR has been shown to be a strong predictor of long-term mortality. The system is designed to address this clinical concern 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 post-dilatation following placement, minimizing the risk of hemodynamic instability for patients.
"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 U.S. and continuing to obtain the same strong outcomes in the pivotal trial," said Tuzcu.
An earlier feasibility phase of the SALUS Trial conducted in 2013 evaluated the system in 30 patients. Thirty-day outcomes demonstrated a survival rate of 97 percen, with 100 percent of patients experiencing mild or less aortic regurgitation. Results also showed low procedural complications, no incidence of stroke and a three percent rate of permanent pacing. The mean aortic gradient decreased from 44.5 mmHg to 12.7 mmHg at 30 days. The previous protocol of the SALUS Trial enrolled more than 100 extreme risk patients in a non-randomized fashion and will continue to be followed independently.
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