Direct Flow Medical, developer of transcatheter heart valve technologies, has enrolled the first patient in the SALUS feasibility trial to evaluate its transcatheter aortic heart valve system in the US.
The non-randomised, multi-centre, core lab-adjudicated, investigational device exemption (IDE) trial is being conducted at six US clinical sites with 30 patients.
The trial is designed to evaluate the use of transcatheter aortic heart valve system, which comprises of a heart valve with a metal-free frame that will be delivered transfemorally through a flexible, 18 French fully sheathed delivery system.
The device is developed to eliminate aortic regurgitation using its low-profile delivery system and also resolve clinical challenges associated with current commercial valves, enhancing the long-term survivability in patients.
Henry Ford Hospital’s Center for Structural Heart Disease medical director Dr William O’Neill performed the first Direct Flow Medical case in the US.
He said the team at Henry Ford Hospital was pleased to be the first in the US to implant the Direct Flow Medical heart valve.
“A device that is repositionable and able to pass through smaller diameter blood vessels is an important advance in the next-generation of transcatheter aortic valve replacement (TAVR) systems,” Dr O’Neill said. “This could help patients who have not been good candidates for earlier TAVR devices.”
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, the company reported.
Northwestern Memorial Hospital chief of cardiac surgery and principal investigator Dr Patrick McCarthy said after surgical aortic valve replacement, aortic regurgitation is rare.
“We need that same level of assurance after a transcatheter procedure, and we look forward to matching those results in this study of the Direct Flow Medical system,” Dr McCarthy said.
The device, which is commercially available in Europe, secured CE Mark approval in the beginning of 2013.
According to GlobalData estimates, Transcatheter Heart Valves market in the US was valued at $280m and is expected to grow at a CAGR of 25.3% to reach $1.36bn by 2019.