Direct Flow Medical said Wednesday it has received FDA investigational device exemption approval for a pivotal study of transcatheter aortic valve system in patients with severe aortic stenosis who are at extreme surgical risk, while reducing the risk of post-procedural aortic regurgitation.
The prospective, nonrandomized, multicenter SALUS trial will evaluate the system using a primary endpoint of all-cause mortality and disabling stroke at 12 months, the company said. The device is designed to reduce the occurrence of post-procedural aortic regurgitation as well.
The transcatheter aortic valve system works by sealing the annulus and enabling complete assessment of hemodynamic performance, according to Direct Flow Medical. The retrievable system allows for the valve to be repositioned after deployment and avoids rapid pacing of the heart during deployment and post-dilatation following placement, minimizing the risk of hemodynamic instability for patients, the Santa Rosa, Calif., company said.
In a 2013 feasibility trial, the device demonstrated a survival rate of 97 percent, few procedural complications, no incidence of stroke, three percent rate of permanent pacing and 100 percent of patients with mild or less aortic regurgitation, the company said.
The transcatheter aortic valve system received CE Mark approval in January 2013 and is commercially available in Europe. — Kellen Owings
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