Modifications Strengthen SALUS Pivotal Trial of Direct Flow Medical's TAVR System

April 28, 2016—Direct Flow Medical, Inc. announced modifications to the SALUS United States pivotal trial of the company's transcatheter aortic valve replacement (TAVR) system to include best practices and clinical comparison with all currently available United States TAVR devices. The trial is investigating the company's device for treating high-risk and extreme-risk severe symptomatic aortic stenosis. The Direct Flow Medical TAVR system is commercially available in Europe for treating extreme surgical-risk aortic stenosis.

According to the company, the SALUS pivotal trial was initiated June 2015 with target enrollment of 1,262 subjects at up to 45 investigational sites in the United States to evaluate the Direct Flow Medical TAVR system with one other TAVR device.

With recent US Food and Drug Administration approvals, the trial now features improved screening, enhanced options for anesthesia, optional intraprocedural dilatation, use of the new DirecTrack delivery system, comparison with all current commercially available TAVR devices in the United States, and a new target enrollment of 648 patients.

Scott Lim, MD, and Isaac George, MD, are coprincipal investigators of the SALUS trial. In the company’s press release, Dr. Lim commented, “Utilizing best practices, comparing with all TAVR devices and being able to evaluate a new delivery system places the SALUS trial at the leading edge of TAVR science.” Dr. George added, “These changes elevate SALUS trial value and meaningfully evaluate product performance relative to available TAVR technology.”

The nonmetallic, conformable Direct Flow Medical TAVR system can be functionally assessed, repositioned, and retrieved before final implantation. In published clinical results, the device has demonstrated low rates of paravalvular leak, pacemaker implantation, and mortality, noted the company.