The FDA granted Direct Flow Medical an investigational device exemption for its transcatheter aortic valve implant, with the medical device company announcing enrollment in its Salus feasibility trial.
Santa Rosa, Calif.-based Direct Flow’s TAVI device employs a metal-free polymer frame delivered transfemorally via a flexible, 18 French delivery system, according to a press release. It’s designed to virtually eliminate aortic regurgitation, a common problem with early-generation TAVI systems.
Post-procedural aortic regurgitation following transcatheter aortic valve replacement is a proven predictor of long-term mortality, Direct Flow noted.
"Paravalvular leak leading to aortic regurgitation continues to be a clinical complication of TAVR and has been correlated to long term unfavorable outcomes," co-principal investigator Dr. Murat Tuczu of the Cleveland Clinic said in a press statement. "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 U.S. feasibility trial."
Direct Flow’s device is designed to address aortic regurgitation by enabling in-situ hemodynamic assessment after the valve is fully deployed, allowing "limitless repositioning with full distal, proximal and planar control, or retrieval, if required," the company claimed.
The system avoids rapid pacing of the heart during deployment, and post-dilatation following placement, which minimizes hemodynamic stress for patients, Direct Flow added.
Direct Flow’s 30-patient Salus feasibility trial to evaluate its transcatheter aortic heart valve system will be conducted at up to 6 U.S. clinical sites, the company said.
Six-month results from Direct Flow’s European Discover CE Mark trial for the device demonstrated excellent survivability, sustained hemodynamic improvements and few adverse events, with minimal occurrence of aortic regurgitation, the company noted.
The devive won CE Mark approval in January and is now available commercially in Europe, but has not been approved for sale in the U.S., Canada or Japan.
"It is a major milestone for our company to bring our rigorous clinical research to the U.S. in order to improve outcomes for patients," CEO Bernard Lyons said in a press statement. "Our device has shown the ability to achieve excellent outcomes while minimizing the risk of aortic regurgitation in our European trials, and we expect to demonstrate the same in our U.S. study."
