IDE Study Green Light For Direct Flow’s Transcatheter Aortic Valve

Direct-Flow-Medical-valveWe’ve covered Direct Flow Medical®’s novel design of transcatheter heart valve quite extensively on these pages. It’s the design in which the metallic stent is replaced by polymer-filled rings for optimal valve seating. Now the company is really able to get the US ball rolling with the news that it has received FDA approval for an Investigational Device Exemption (IDE) to begin the SALUS feasibility trial of its system.

Background

Direct Flow Medical’s transcathetr aortic valve looks like no other such device. It encompasses a distinctive metal-free frame and flexible, low-profile delivery system that virtually eliminates aortic regurgitation. Direct Flow says it’s design aims to improve the long term survivability of patients by resolving the clinical issues associated with current commercial valves.

Read more about the device here.

The Direct Flow Medical Transcatheter Aortic Valve System is designed to address the issue of paravalvular regurgitation by enabling in-situ hemodynamic assessment after the valve is fully deployed in the native valve annulus, coupled with limitless repositioning with full distal, proximal and planar control, or retrieval, if required. The system avoids rapid pacing of the heart during deployment, and post-dilatation following placement, minimizing the risk of hemodynamic stress for patients.

Direct Flow Medical will now commence its U.S. clinical study evaluating the use of the Direct Flow Medical Transcatheter Aortic Heart Valve 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. Murat Tuczu MD, Professor of Medicine, Cleveland Clinic 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.

Physician comments

“Paravalvular leak leading to aortic regurgitation continues to be a clinical complication of TAVR and has been correlated to long term unfavorable outcomes,” said Murat Tuczu, co-principal investigator of the trial. “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.”

Company comments

“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,” said Direct Flow Medical Chief Executive Officer Bernard Lyons. “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.”

Regulatory status

The Direct Flow Medical system received the CE Mark in January 2013 and is currently available commercially in Europe.

Source: Direct Flow Medical Inc.