Direct Flow Medical has announced that the first patient in its US SALUS clinical trial, which is evaluating the company’s transcatheter aortic valve implantation (TAVI) device, has been enrolled. The non-randomised, multicentre, core lab-adjudicated, investigational device exemption (IDE) trial of 30 patients is being conducted at six US clinical sites.
A press release reports that Direct Flow Medical’s TAVI system encompasses a distinctive transcatheter aortic heart valve with a metal-free frame and flexible, low-profile delivery system and is designed to eliminate aortic regurgitation. It adds that the device is intended to improve the long-term survivability of aortic stenosis patients by resolving the clinical issues associated with current commercial valves.
Principal investigators for the SALUS Trial are Murat Tuzcu, vice chairman of the Department of Cardiology, Cleveland Clinic, USA, and Patrick McCarthy, director of the Bluhm Cardiovascular Institute and chief of Cardiac Surgery, Northwestern Memorial Hospital, USA. William O’Neill, medical director of the Center for Structural Heart Disease at Henry Ford Hospital, USA, performed the first Direct Flow Medical case in the USA. He said: “The team at Henry Ford Hospital is pleased to be the first in the USA 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 TAVI systems. This could help patients who have not been good candidates for earlier TAVI devices.”
Direct Flow Medical will be participating in the PCR London Valves scientific programme (15–17 September, London, UK), including a symposium entitled “Direct Flow Medical Transcatheter Aortic Valve” on 17 September from 1pm to 2pm in Room 2 (Whittle), as well as a live case performed from St Thomas Hospital, London on Monday, September 16 from 11:30am to 12:30pm in the Main Arena.