DIRECT FLOW MEDICAL, INC. ANNOUNCES IDE APPROVAL FOR U.S. PIVOTAL TRIAL
SANTA ROSA, Calif. and PARIS, France — May 21, 2014 — Direct Flow Medical®, Inc., a transcatheter heart valve company focused on innovation for improved patient outcomes, has received Investigational Device Exemption (IDE) approval from the Food and Drug Administration (FDA) to initiate the pivotal phase of the SALUS Trial. The SALUS Trial is a prospective, non-randomized, multi-center, core lab adjudicated clinical trial, evaluating the Direct Flow Medical Transcatheter Aortic Valve System at up to 30 sites. This technology is the first in class designed to treat aortic stenosis by replacing the patient’s native aortic valve, while minimizing the degree and frequency of aortic regurgitation.
The fully repositionable and retrievable Direct Flow Medical system is designed to treat patients with severe aortic stenosis who are at extreme surgical risk, while reducing the risk of post-procedural aortic regurgitation, a strong predictor of long-term mortality1. The system addresses this clinical concern by sealing the annulus and enabling complete assessment of hemodynamic performance with unlimited repositioning of the valve after full deployment. The system avoids rapid pacing of the heart during deployment and post-dilatation following placement, minimizing the risk of hemodynamic instability for patients.
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.
“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 Direct Flow Medical Chief Medical Officer Charles Davidson, M.D.
The Direct Flow Medical system received the CE Mark in January 2013 and is currently available commercially in Europe.
The benefits of the Direct Flow Medical Transcatheter Aortic Valve System are enabled by its design, which features a distinctive, metal-free frame. Rather than a metal stent, the Direct Flow Medical System incorporates a polymer frame, which is expanded using pressurized saline and contrast for placement, assessment and repositioning. The saline/contrast solution is easily exchanged for a quick-curing polymer that solidifies and secures the valve in place once optimal positioning is reached. 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. 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.
About Direct Flow Medical, Inc.
Founded in 2004, Direct Flow Medical, Inc. is focused on developing novel transcatheter heart valve technologies that improve patient outcomes while reducing patient complications. The company is headquartered in Santa Rosa, California, with technology and manufacturing facilities in Lake Forest, California. The Company’s proprietary technology is not limited to aortic valve disease, and is readily applicable to mitral and other heart valve anatomical sites. Direct Flow Medical investors include EDF Ventures, New Leaf Venture Partners, Spray Venture Partners, Foundation Medical Partners, VantagePoint Venture Partners, ePlanet Venture Partners and strategic corporate investors. For further information, please visit the Web site at www.directflowmedical.com.
1Kodali S, Williams M Smith C, et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med 2012;366(18):1686-1695.
2Schofer J, Colombo A, Klugman S, et al. Prospective Multicenter Evaluation of the Direct Flow Medical Transcatheter Aortic Valve. J Am Coll Card 2014;63:763-8.
The Direct Flow Medical Transcatheter Aortic Valve System has not been approved for sale in the USA, Canada, or Japan.
Direct Flow Medical and the Direct Flow Medical logo are trademarks of Direct Flow Medical, Inc.