Direct Flow Medical Transcatheter Aortic Valve System Demonstrates Excellent 30 Day Outcomes Following Full Enrollment of DISCOVER CE Mark Trial
Results Presented in Oral Presentation at EuroPCR
PARIS, France, May 22, 2013 – Direct Flow Medical®, Inc., a transcatheter heart valve innovator focused on improving patient outcomes, today announced that it has met its primary endpoint in the fully-enrolled, 100-patient DISCOVER CE Mark Trial by achieving 99 percent freedom from all-cause mortality at 30 days. Patients were treated with the Direct Flow Medical® Transcatheter Aortic Valve System and demonstrated excellent results relative to overall patient hemodynamics, as well as the avoidance of post-procedural aortic regurgitation and adverse events. The DISCOVER Trial full 30-day outcomes were presented today by trial investigator Joachim Schofer, MD, from the Medical Care Center, Hamburg, Germany.
The Direct Flow Medical Transcatheter Aortic Valve System is designed to minimize the risk of aortic regurgitation following transcatheter aortic heart valve implantation (TAVI). In the DISCOVER Trial, 99 percent of patients experienced mild or less aortic regurgitation, with 73 percent experiencing none/trace aortic regurgitation. The mean gradients pre-procedure, at discharge and out to 30 days of 46mmHg, 14.1mmHg and 12.6mmHg, respectively, demonstrated the system’s ability to significantly reduce, and then maintain, low gradients over time. All hemodynamic outcomes were assessed and reported by an independent imaging core laboratory.
The VARC defined Combined Safety rate was 89 percent. Within 30 days, there were two strokes (major or minor) and one patient experienced a myocardial infarction. There were only two major vascular complications, despite accessing vessels as small as 5.2mm. The VARC defined Device Success rate was 91 percent. No patient required rapid pacing during deployment or post-dilatation following deployment, minimizing the risk of hemodynamic stress for patients.
At 30 days, 83 percent of patients had improved by more than one New York Heart Association (NYHA) functional class, and 68 percent were classified as NYHA Class I. The average age of patients in the trial was 83.1 years, with a mean logistic euroSCORE of 22.5 percent.
“These results are unprecedented for a TAVI device,” said Professor Schofer. “The Direct Flow Medical system is demonstrating in this landmark trial that it can successfully treat aortic stenosis with low mortality, while at the same time addressing the issue of aortic regurgitation in a clinically meaningful way in order to significantly improve patient outcomes.”
The DISCOVER Trial is a prospective, multicenter study conducted at nine European sites in 100 patients with severe aortic valve stenosis who require replacement of their native aortic valve but are at extreme risk for open surgical repair. The device studied was the Direct Flow Medical Transcatheter Aortic Valve System, which includes a distinctive heart valve with a metal-free frame that was delivered transfemorally via a flexible, 18 French delivery system.
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 initially 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.
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 logo are trademarks of Direct Flow Medical, Inc.