SANTA ROSA, Calif. & PARIS--(BUSINESS WIRE)--Direct Flow Medical®, Inc., an innovative structural heart company, today announced 30-day outcomes from the DISCOVER post-market registry that demonstrate excellent real world results for the Direct Flow Medical Transcatheter Aortic Valve System consistent with the ground-breaking results seen in the DISCOVER CE Mark Trial. The data were presented yesterday at the EuroPCR conference in Paris, France by Christoph C. K. Naber, MD, PHD, from the Contilia Heart Center in Essen, Germany.
The 30-day data on 250 all-comer patients from the DISCOVER post-market study showed a 98 percent survival rate, which emulated the 99 percent survival rate previously reported at 30 days from the DISCOVER CE Mark Trial. The average age of patients in the trial was 82.5 years, with a mean logistic euroSCORE of 18.3 percent.
Mild or less post-procedural aortic regurgitation was achieved in 97 percent of patients, with 80 percent of patients experiencing none to trace aortic regurgitation.
The stroke rate and incidence of myocardial infarction within 30 days was low, at two percent and .8 percent, respectively. A low major vascular complications rate of four percent demonstrates the system’s flexibility and trackability even in tortuous anatomy. No patient required rapid pacing during deployment or post-dilatation following deployment, minimizing the risk of hemodynamic stress. In addition, no patient required more than one valve, eliminating the need for a valve-in-valve procedure and the associated negative outcomes observed with non-retrievable transcatheter aortic valves.
"Treating patients with the Direct Flow Medical valve in a real-world setting and getting the same consistent results seen in the clinical trial shows outstanding performance," said Dr. Naber. "In daily practice we are faced with patients that are normally excluded by protocol from clinical studies, but these patients need treatment, as well. It is reassuring to know that we can reproduce the same results in challenging clinical scenarios with this valve."
The DISCOVER Post-Market Study is a prospective, multicenter, all-comers registry of up to 1,000 patients conducted at up to 75 European sites to evaluate the outcomes of the Direct Flow Medical valve on patients with severe aortic stenosis in routine clinical practice.
The fully repositionable and retrievable Direct Flow Medical system is designed to treat patients with severe aortic stenosis, 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 “in situ” repositioning of the valve after full deployment. The system includes a distinctive heart valve with a metal-free frame, delivered transfemorally via the same flexible delivery system for all sizes (23mm, 25mm, 27mm and 29mm).
The Direct Flow Medical system received the CE Mark in January 2013 for the treatment of patients with aortic stenosis who are at extreme surgical risk. The system is currently available commercially in Europe and enrolling a pivotal trial in the United States.
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, initially aimed at aortic valve disease, is applicable to a broad range of structural heart diseases. Direct Flow Medical investors include EDF Ventures, New Leaf Venture Partners, Spray Venture Partners, Foundation Medical Partners, VantagePoint Venture Partners, ePlanet Venture Partners, SV Life Sciences 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 use in the USA, Canada, or Japan.
Direct Flow Medical and the Direct Flow logo are trademarks of Direct Flow Medical, Inc.