The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval for Direct Flow Medical to expand its SALUS pivotal trial.
FDA IDE approval will allow the company to include the high risk patients and randomization against a commercial device, the Medtronic CoreValve.
The SALUS Trial is a prospective, randomized, multi-center, core lab adjudicated US clinical trial designed to assess the Direct Flow Medical Transcatheter Aortic Valve System.
According to the company, the primary endpoint of the trial is a composite of all-cause mortality and disabling stroke at 12 months.
The expansion of the trial includes treatment of high surgical risk patients and continued treatment of extreme risk patients and 2:1 randomization to Medtronic CoreValve.
In addition, the trial will include registries for non-femoral access points and type 2 and 3 bicuspid valves.
Direct Flow Medical system has been designed to treat patients with severe aortic stenosis who are at high or extreme surgical risk by replacing the native aortic valve, while minimizing the degree and frequency of aortic regurgitation (AR).
It is being developed to avoid rapid pacing of the heart during deployment and post-dilatation following placement, minimising the risk of hemodynamic instability for patients.
SALUS trial that was conducted in 2013 assessed the system in 30 patients, demonstrating a survival rate of 97% with maximum percent of patients experiencing mild or less aortic regurgitation, noted the company.
In 2013, the Direct Flow Medical system received CE mark approval and is currently marketed in Europe.