First Patient Enrolls in Direct Flow Medical® U.S. Transcatheter Aortic Valve Trial

We rather admire the folk at Direct Flow Medical®, Inc., for their originality in developing a transcatheter heart valve that breaks the mold of requiring a metal stent. Now the company has announced the first patient enrollment in the U.S. SALUS clinical trial.

Background

Post-procedural aortic regurgitation following Transcatheter Aortic Valve Implantation (TAVI) is a well-understood predictor of long-term mortality. It was a feature that dogged early valve designs and remains a concern for physicians. Direct Flow Medical threw away the rule book in developing the concept of a device that possessed a distinctive metal-free frame, possessing a fillable “ring” construct to both aid in imaging and secure in the desired position. Its flexible, low-profile delivery system is designed specifically to eliminate aortic regurgitation and aims to improve the long term survivability of aortic stenosis patients by resolving a number of clinical issues: Direct Flow Medical says its device enables in-situ hemodynamic assessment after the valve is fully deployed in the native valve annulus, as well as repositioning with full distal, proximal and planar control, or retrieval, if required. The system avoids rapid pacing of the heart during deployment, and does not require post-dilatation following placement, minimizing the risk of hemodynamic stress for patients.

The so-called SALUS Trial is a non-randomized, multi-center, core lab-adjudicated, Investigational Device Exempt (IDE) trial of 30 patients being conducted at six U.S. clinical sites. Principal investigators for the SALUS Trial are Murat Tuzcu, M.D., Vice Chairman of the Department of Cardiology, Cleveland Clinic, and Patrick McCarthy, M.D., Director of the Bluhm Cardiovascular Institute and Chief of Cardiac Surgery, Northwestern Memorial Hospital.

Physician/investigator comments 

William O’Neill, M.D., Medical Director of the Center for Structural Heart Disease at Henry Ford Hospital performed the first Direct Flow Medical case in the United States.

“The team at Henry Ford Hospital is pleased to be the first in the U.S. to implant the Direct Flow Medical heart valve,” said Dr. O’Neill. “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. This could help patients who have not been good candidates for earlier TAVR devices.”

“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,” said Dr. McCarthy.

On show in Europe

The Direct Flow Medical System received the CE Mark in January 2013 and is currently available commercially in Europe. The company will be participating in the PCR London Valves scientific programme, including a symposium entitled “Direct Flow Medical Transcatheter Aortic Valve” on Tuesday, September 17 from 13:00 to 14:00 in Room 2 (Whittle), as well as a live case performed from St. Thomas Hospital, London on Monday, September 16 from 11:30 to 12:30 in the Main Arena.

Source: Direct Flow Medical, Inc.