Direct Flow Medical®, Inc. has received Investigational Device Exemption (IDE) approval from the U.S. FDA to broaden the SALUS Trial into its novel transcatheter heart valve, to include the addition of high risk patients and randomization against Medtronic’s CoreValve®.
Use of the word “Innovation” should be restricted to devices like the inflatable transcatheter heart valve from Direct Flow Medical. Readers of our pages will remember that this is a distinctive device featuring a metal-free frame, expanded in situ using pressurized saline and contrast for placement, assessment and repositioning. The saline/contrast solution is then exchanged for a quick-curing polymer that solidifies and secures the valve in place once optimal positioning is reached. The design is contrived to address the toughest part of transcatheter valve implantation, which is achieving a tight seal around the annulus through optimal placement.
The SALUS Trial is a prospective, randomized, multi-center, core lab adjudicated U.S. clinical trial, evaluating the Direct Flow Medical Transcatheter Aortic Valve System. An earlier feasibility phase of the SALUS Trial conducted in 2013 evaluated the system in 30 patients and demonstrated a survival rate of 97 percent with 100 percent of patients experiencing mild or less aortic regurgitation. The previous protocol of the SALUS Trial has enrolled more than 100 extreme risk patients in a non-randomized fashion and will continued to be followed independently.
The expansion of the SALUS Trial means it now includes high surgical risk patients and continued treatment of extreme risk patients, a 2:1 randomization to Medtronic CoreValve® and a 912 subject pivotal cohort. It extends to up to 45 sites in the U.S. and will yield registries for non-femoral access points and type 2 and 3 bicuspid valves
“We have been working closely with the FDA since the early development of the Direct Flow Medical technology and it has been a collaborative effort with the FDA which has led to an expansion of the SALUS trial. The technology has shown outstanding performance in clinical trials and commercial settings, significantly reducing the risk of aortic regurgitation with excellent survival. We look forward to expanding the clinical use to additional centers in the U.S. and continuing to obtain the same strong outcomes in the pivotal trial,” said Dr. Tuzcu.
Source: Direct Flow Medical, Inc.