Direct Flow Medical said the FDA granted an investigational device exemption for a U.S. pivotal trial for its transcatheter aortic valve implant.
The 30-patient feasibility phase of Direct Flow’s Salus trial last year 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, according to a press release.
The Salus trial’s pivotal phase will involve up to 30 sites, with a primary endpoint of composite all-cause mortality and disabling stroke at 12 months, Direct Flow said.
"We have been working closely with the FDA since the early development of the Direct Flow Medical technology and it has been a collaborative effort with the FDA which has led to an approval to start the pivotal phase of the Salus trial," chief medical officer Dr. Charles Davidson said in prepared remarks. "The technology has shown outstanding performance in clinical trial and commercial settings, significantly reducing the risk of aortic regurgitation and improving patient survival. We look forward to expanding the clinical use to additional centers in the U.S. and continuing to obtain the same strong outcomes in the pivotal trial."
Direct Flow won CE Mark approval in the European Union for its TAVI device in January 2013.
