Direct Flow Medical has obtained the US Food and Drug Administration’s (FDA) Investigational Device Exemption (IDE) approval to initiate the pivotal phase of the SALUS clinical trial, a core lab adjudicated trial evaluating the transcatheter aortic valve system.
The prospective, non-randomized SALUS clinical trial is evaluating the Direct Flow Medical transcatheter aortic valve system at up to 30 sites. Primary endpoint of the clinical trial is a composite of all-cause mortality and disabling stroke at 12 months.
Direct Flow Medical has designed the transcatheter aortic valve system to treat patients with severe aortic stenosis who are at extreme surgical risk, while reducing the risk of post-procedural aortic regurgitation.
The fully repositionable and retrievable system addresses this clinical concern by sealing the annulus and enabling complete assessment of hemodynamic performance with unlimited repositioning of the valve after full deployment.
Direct Flow Medical claims that the system avoids rapid pacing of the heart during deployment and post-dilatation following placement, minimizing the risk of hemodynamic instability for patients.
Direct Flow Medical Chief Medical Officer Dr Charles Davidson said that the company has 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.
"The technology has shown outstanding performance in clinical trial and commercial settings, significantly reducing the risk of aortic regurgitation and improving patient survival" Dr Davidson added.
"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 Medical obtained CE Mark approval in January 2013, for the transcatheter aortic valve system. Currently, the device is available commercially in Europe.