The FDA’s investigational device exemption for the Salus trial also allows Santa Rosa, Calif.-based Direct Flow to enroll a high-risk cohort, the company said. Direct Flow makes a repositionable and retrievable transcatheter aortic valve implant to treat aortic stenosis.
The 30-patient feasibility phase of the Salus trial, which entered its pivotal phase in May 2014, 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 for the pivotal phase is a composite of all-cause mortality and disabling stroke at 12 months in extreme-risk patients.
Direct Flow said the trial can now be expanded to 912 patients including the high-risk group, randomized 2-to-1 with Medtronic’s CoreValve TAVI. Registries for non-femoral access and Type 2 and Type 3 bicuspid valves can also begin, the company said.
Co-principal investigator Dr. Murat Tuzcu of the Cleveland Clinic said the expanded IDE is the result of a collaborative effort with the FDA.
"The technology has shown outstanding performance in clinical trials and commercial settings, significantly reducing the risk of aortic regurgitation with excellent 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," Tuzcu said in prepared remarks.
Direct Flow won CE Mark approval in the European Union for its TAVI device in January 2013.