Direct Flow Medical out of Santa Rosa, California received an FDA green light to begin a feasibility trial of the company’s second-generation Transcatheter Aortic Heart Valve System in patients with aortic stenosis.
The device is positioned around the stenotic valve and inflated to fully replace the original functionality. This polymer-based device that has no metal parts, and it can be deflated and repositioned or removed at anytime. Rapid pacing of the heart is not required when placing the prosthesis, reducing the stress put on the heart during the procedure. According to the company, the device “encompasses a distinctive transcatheter aortic heart valve with a metal-free frame and flexible, low-profile delivery system that virtually eliminates aortic regurgitation.”
From the company’s announcement:
With receipt of IDE approval, Direct Flow Medical plans to commence its U.S. clinical study evaluating the use of the Direct Flow Medical Transcatheter Aortic Heart Valve System. The system includes a distinctive heart valve with a metal-free frame that will be delivered transfemorally via a flexible, 18 French delivery system. The SALUS Trial is a 30-patient feasibility trial that will be conducted at up to six U.S. clinical sites, led by co-principal investigators Dr. Tuzcu and Vinod Thourani, MD, Associate Professor of Surgery, Division of Cardiothoracic Surgery, Department of Surgery, Emory University School of Medicine and the Emory Clinic.
Six-month results from the company’s DISCOVER CE Mark Trial presented at the American College of Cardiology (ACC) 2013 Annual Meeting, which studied the Direct Flow Medical system, demonstrated excellent survivability, sustained hemodynamic improvements and few adverse events, with minimal occurrence of aortic regurgitation.
The Direct Flow Medical system received the CE Mark in January 2013 and is currently available commercially in Europe.
Flashbacks: Catheter Delivered Aortic Valve from Direct Flow Medical Wins European Clearance; Direct Flow Medical Transcatheter Aortic Valve Does Well in Clinical Study
Product page: Direct Flow Medical Transcatheter Aortic Valve System…
Press release: Direct Flow Medical® Receives Ide Approval for U.S. Salus Trial of Transcatheter Aortic Heart Valve System…