Dr. George Named Coprincipal Investigator for Direct Flow's US SALUS Trial

June 4, 2015—Direct Flow Medical, Inc. announced that Isaac George, MD, has been named coprincipal investigator of the United States SALUS pivotal trial. SALUS is a prospective, randomized, multicenter, core-lab adjudicated, United States clinical trial that is evaluating the Direct Flow Medical transcatheter aortic valve replacement (TAVR) system. The trial’s primary endpoint is a composite of all-cause mortality and disabling stroke at 12 months. 

Direct Flow Medical stated that Dr. Isaac is Surgical Director of Transcatheter Therapies for the Columbia Heart Valve Center, Director of Hybrid Coronary Interventions, and an Assistant Professor of Surgery at the Columbia University Medical Center in New York, New York.

Dr. George will lead the trial with coprincipal investigator Murat Tuzcu, MD, Vice Chairman of the Department of Cardiology for the Cleveland Clinic in Cleveland Ohio.

In the company’s press release, Dr. Isaac commented, “I am passionate about integrating new technologies and innovation, such as TAVR, into clinical practice in order to enhance patient care. The Direct Flow Medical technology has demonstrated excellent outcomes in both clinical study and commercial settings to date, and I am enthusiastic about leading the definitive study of its efficacy in the United States, in partnership with Dr. Tuzcu.”

Dr. Tuzcu added, “I look forward to working with Dr. George as we expand the SALUS trial. His surgical expertise, combined with his interest in hybrid and cutting-edge treatments, such as TAVR, will be invaluable as we partner with Heart Teams around the country to explore this next-generation Direct Flow Medical technology.”

In April, Direct Flow Medical announced it had received US Food and Drug Administration approval for an investigational device exemption to broaden the SALUS trial. The expansion of the trial includes the addition of high-risk surgical patients; 2:1 randomization against a commercial device (CoreValve, Medtronic plc); a 912-patient pivotal cohort treated at up to 45 sites in the United States; and registries for nonfemoral access points and bicuspid valves.