Direct Flow Valve IDE Study to Start

Compared with the cardiovascular leviathons, Direct Flow Medical®, Inc., is a comparative minnow. That said, we like the concept behind its novel transcatheter aortic valve implant (TAVI) and have covered its progress a lot on our pages. Now Direct Flow has received Investigational Device Exemption (IDE) approval from the U.S. FDA to initiate the pivotal phase of its SALUS Trial, which is an important stepping stone towards U.S. approval.

Background

Regular visitors will know that the design of Direct Flow’s TAVI device differs from all the rest by featuring a distinctive, metal-free frame. Expansion of the device is achieved using  pressurized saline and contrast which fills the twin rings of the valve and allows for placement, assessment and repositioning. Once in position the saline/contrast solution is exchanged for a quick-curing polymer that solidifies and secures the valve in place. The unique double-ring design of the valve creates a tight seal around the annulus. The system is fully repositionable and retrievable up until polymer exchange, optimal positioning theoretically reducing the risk of post-procedural aortic regurgitation, a strong predictor of long-term mortality.  The metal-free design enables a low-profile (18 French), fully sheathed delivery system for all valve sizes that minimizes vascular complications and improves hemodynamic outcomes.

The SALUS Trial is a prospective, non-randomized, multi-center, core lab adjudicated clinical trial, evaluating the Direct Flow system at up to 30 sites. The primary endpoint of the trial is a composite of all-cause mortality and disabling stroke at 12 months. 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.

An earlier feasibility phase of the SALUS Trial conducted in 2013 evaluated the system in 30 patients. The 30 day outcomes were presented today by Dr. Tuzcu at the EuroPCR conference, demonstrating a survival rate of 97 percent, low procedural complications, no incidence of stroke, a three percent rate of permanent pacing and 100 percent of patients with mild or less aortic regurgitation. The mean aortic gradient decreased from 44.5 mmHg to 12.7 mmHg at 30 days.

Company comments

“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 approval to start the pivotal phase of the SALUS trial. The technology has shown outstanding performance in clinical trial and commercial settings, significantly reducing the risk of aortic regurgitation and improving patient 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 Charles Davidson, M.D., Direct Flow Medical Chief Medical Officer.

Regulatory status

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

Source: Direct Flow Medical, Inc.

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