DIRECT FLOW MEDICAL® TRANSCATHETER AORTIC VALVE SYSTEM DEMONSTRATES EXCELLENT 12 MONTH OUTCOMES IN DISCOVER CE MARK TRIAL
SANTA ROSA, Calif. and PARIS, France – May 22, 2014 – Direct Flow Medical®, Inc., a transcatheter heart valve innovator focused on improving patient outcomes, today announced 12 month outcomes from the DISCOVER CE Mark Trial. In the trial, a 90 percent survival rate was reported, continuing the initial positive trend of 99 percent survival after 30 days. Patients were treated with the Direct Flow Medical® Transcatheter Aortic Valve System and experienced excellent overall hemodynamic results, as well as a low rate of procedural complications. At 12 months, 100 percent of patients experienced mild or less aortic regurgitation (AR), with 77 percent having none or trace AR. The DISCOVER Trial 12 month outcomes were presented today by principal investigator Joaquim Schofer, MD, from the Medical Care Center, Hamburg, Germany.
The fully repositionable and retrievable Direct Flow Medical system is designed to treat patients with severe aortic stenosis who are at high or extreme surgical risk, while reducing the risk of post-procedural AR, a strong predictor of long-term mortality. 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. It avoids both rapid pacing of the heart during deployment and post-dilatation following placement, minimizing the risk of hemodynamic instability for patients. The system includes a distinctive heart valve with a metal-free frame, delivered transfemorally via a flexible, 18 French delivery system for all sizes (23mm, 25mm, 27mm and 29mm).
In the DISCOVER Trial, the mean transthoracic echo gradient at 30 days was 12.5mmHg and remained low at 12 months (12.3mmHg). All hemodynamic outcomes were assessed and reported by an independent imaging core laboratory. The VARC Defined Device Success rate was 91 percent. At 30 days, 83 percent of patients had improved by more than one New York Heart Association (NYHA) functional class and this was maintained at 12 months, with 95 percent classified as NYHA Class I/II.
“The 12 month DISCOVER results are unprecedented for a TAVI device,” said Professor Schofer. “The Direct Flow Medical system has demonstrated that it successfully treats aortic stenosis with low mortality, while at the same time addressing the very serious issue of aortic regurgitation in a clinically meaningful way in order to significantly improve patient outcomes.”
The initial DISCOVER Trial was a prospective, multicenter study conducted at nine European sites of 100 patients with severe aortic valve stenosis who required replacement of their native aortic valve but were at extreme risk for open surgical repair. The trial has since expanded to additional sites and patients, enrolling patients in 23mm valve and 29mm valve trial arms. The 29mm valve received CE Mark in December 2013 and the 23mm valve is pending CE Mark approval.
The Direct Flow Medical system received the CE Mark in January 2013 and is currently available commercially in Europe.
About The Direct Flow Medical System
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.
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.About Direct Flow Medical, Inc.
The Direct Flow Medical Transcatheter Aortic Valve System has not been approved for use in the USA, Canada, or Japan.
Direct Flow Medical and the Direct Flow logo are trademarks of Direct Flow Medical, Inc.