Direct Flow Medical® Names Co-principal Investigator for U.S. Pivotal Study

Transcatheter Heart Valve innovator Direct Flow Medical®, Inc., has named the man who will spearhead its pivotal trial in the U.S.


Direct Flow Medical tells us that Isaac George, MD, surgical director of transcatheter therapies for the Columbia Heart Valve Center at the Columbia University Medical Center, has been named co-principal investigator of the U.S. SALUS pivotal trial studying the Direct Flow Medical Transcatheter Heart Valve System.

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.

Dr. George joins co-principal investigator Murat Tuzcu, MD, vice chairman of the department of cardiology for the Cleveland Clinic, in leading the trial.

Dr. George’s credentials include also being current director of hybrid coronary interventions and an assistant professor of surgery at Columbia University Medical Center, where he has performed more than 1,500 open heart surgeries and valve procedures. He joined New York Presbyterian/Columbia University Medical Center in the Department of Surgery as a resident in general surgery following his graduation from Duke University School of Medicine. While at Columbia, he completed fellowship programs in cardiothoracic surgery and interventional cardiology/hybrid cardiac surgery. Dr. George is heavily involved in both benchtop and clinical research relating to transcatheter aortic valve replacement (TAVR), heart failure and other heart disease, and possesses a special interest in cutting-edge medical technology

Direct Flow Medical recently received Investigational Device Exemption (IDE) approval from the U.S. FDA 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, the Medtronic CoreValve®; a 912-subject pivotal cohort treated at up to 45 U.S. sites; and registries for non-femoral access points and bicuspid valves.

Investigator comments

“I am passionate about integrating new technologies and innovation, such as TAVR, into clinical practice in order to enhance patient care,” said Dr. George. “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.”

“I look forward to working with Dr. George as we expand the SALUS Trial,” said Dr. Tuzcu. “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.”

 Company comments

“We would like to thank Dr. Patrick McCarthy of Northwestern for his earlier leadership efforts representing the surgical perspective within the SALUS Trial,” said Daniel Lemaitre, Direct Flow Medical Chief Executive Officer. “We look forward to this next phase of the trial and fully expect our technology to demonstrate the same outstanding performance in new patient populations and in a broader setting.”

Source: Direct Flow Medical, Inc.

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