Direct Flow Medical, a US-based developer of transcatheter heart valve technologies, has obtained the consent of United States Food and Drug Administration (FDA) to initiate the SALUS feasibility trial of its Transcatheter Aortic Heart Valve System.
With the approval for an Investigational Device Exemption (IDE) in place, the company plans to begin its clinical study in the US to evaluate the use of the system, which comprises a heart valve with a metal-free frame that will be delivered transfemorally through a flexible, 18 French delivery system.
As part of the SALUS feasibility trial, Direct Flow Medical will enroll 30 patients at up to six US clinical sites.
Co-principal investigator of the trial and Cleveland Clinic professor of medicine Dr. Murat Tuczu said Paravalvular leak leading to aortic regurgitation continues to be a clinical complication of transcatheter aortic heart valve replacement (TAVR) with a correlation to long-term unfavorable outcomes.
"The Direct Flow Medical system has shown the ability to virtually eliminate this problem, and I look forward to studying this promising new treatment in this US feasibility trial," Dr. Tuczu added.
Direct Flow Medical claims that the device would eliminate aortic regurgitation using its low-profile delivery system and also resolve clinical challenges associated with current commercial valves, thereby enhancing the long-term survivability in patients.
The device also enables in-situ haemodynamic assessment once the valve is completely deployed in the native valve annulus and avoids rapid pacing of the heart at the time of deployment.
By also avoiding post-dilatation after the placement, the system helps minimise the risk of haemodynamic stress for patients, said the company.
Direct Flow Medical chief executive officer Bernard Lyons remarked that the approval marks a major milestone for the company to bring in rigorous clinical research to the US for improving outcomes for patients.
"Our device has shown the ability to achieve excellent outcomes while minimising the risk of aortic regurgitation in our European trials, and we expect to demonstrate the same in our US study," added Lyons.
The device, which is commercially available in Europe, secured CE Mark approval in the beginning of 2013.