SALUS Enrollment Begins for Direct Flow Medical's TAVR System

September 10, 2013—Direct Flow Medical, Inc. (Santa Rosa, CA) announced the first patient enrollment in the SALUS clinical trial in the United States of the company's transcatheter aortic heart valve replacement (TAVR) system. The device includes a metal-free frame and flexible, low-profile delivery system designed to improve the long-term survivability of aortic stenosis patients by eliminating aortic regurgitation, a clinical issue currently associated with TAVR.

In May, the company announced US Food and Drug Administration approval to conduct the SALUS trial. 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, advised the company.

Direct Flow Medical stated that the SALUS trial is a nonrandomized, multicenter, core lab-adjudicated, investigational device exemption trial of 30 patients being conducted at six clinical sites in the United States. The Principal Investigators for the SALUS trial are Murat Tuzcu, MD, and Patrick McCarthy, MD. Dr. Tuzcu is Vice Chairman of the Department of Cardiology at the Cleveland Clinic. Dr. McCarthy is Director of the Bluhm Cardiovascular Institute and Chief of Cardiac Surgery at Northwestern Memorial Hospital in Chicago.

“After surgical aortic valve replacement, aortic regurgitation is rare. We need that same level of assurance after a transcatheter procedure, and we look forward to matching those results in this study of the Direct Flow Medical system,” commented Dr. McCarthy in the company's press release.

William O'Neill, MD, who is Medical Director of the Center for Structural Heart Disease at Henry Ford Hospital in Detroit, performed the first Direct Flow TAVR case in the United States.

“The team at Henry Ford Hospital is pleased to be the first in the United States to implant the Direct Flow Medical heart valve,” Dr. O'Neill said in the company's press release. “A device that is repositionable and able to pass through smaller-diameter blood vessels is an important advance in the next generation of TAVR systems. This could help patients who have not been good candidates for earlier TAVR devices.”

According to the company, the Direct Flow TAVR system enables in situ hemodynamic assessment after the valve is fully deployed in the native valve annulus, as well as repositioning with full distal, proximal, and planar control, or retrieval, if required. The system avoids rapid pacing of the heart during deployment, and does not require post-dilatation after placement, minimizing the risk of hemodynamic stress for patients.