Recent TAVR approvals prompt changes to Direct Flow’s Salus trial

direct-flow-medical-updated-1×1 Direct Flow Medical said today that recent FDA approvals for transcatheter aortic valve replacements prompted it to make changes to the Salus trial of its own TAVR entry.

Salus, originally aimed at enrolling 1,262 patients, is now expected to enroll a little more than half that number, 648 subjects, the company said. Santa Rosa, Calif.-based Direct Flow is also adding best practices and comparisons to TAVRs that are already on the U.S. market, which include the Sapien line from market leader Edwards Lifesciences (NYSE:EW) and the Medtronic (NYSE:MDT) CoreValve device.

The 30-patient feasibility phase of for Salus in 2013 showed a 30-day survival rate of 97%, low procedural complications, no incidence of stroke, a 3% rate of permanent pacing and 100% of patients with mild or less aortic regurgitation. The primary endpoint is composite all-cause mortality and disabling stroke at 12 months.

“Based on recent FDA 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 U.S. TAVR devices and a new target enrollment of 648 subjects,” the company said.

“The strengthened Salus trial design reflects our agility in a dynamic global TAVR market to provide the scientific community with a truly meaningful investigation and enhances our ability to achieve our year-end enrollment target,” president & CEO Dan Lemaitre said in prepared remarks.

“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,” added co-principal investigator Dr. Scott Lim of the University of Virginia.

Direct Flow won CE Mark approval in the European Union for its TAVI device in January 2013.

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