May 22, 2015 — Direct Flow Medical Inc. announced positive two-year data from the DISCOVER CE Mark Trial studying its Direct Flow Medical Transcatheter Aortic Valve System at the EuroPCR conference in Paris, France. Demonstrating excellent patient outcomes with few complications, the two-year data were presented by Antonio Colombo, M.D., Ph.D., from the Ospedale San Raffaele in Milan, Italy.
The DISCOVER CE Mark Trial demonstrated an 80 percent survival rate at 24 months, continuing the positive trend showing 90 percent survival after one year and 99 percent after 30 days. All patients experienced mild or less post-procedural aortic regurgitation (AR), with 85 percent having none or trace AR. The mean gradient remained stable at 12.4mmHg at 24 months, compared to 12.6mmHg at 30 days. At the two-year mark, 92 percent of patients had improved by more than one New York Heart Association (NYHA) functional class, improving upon the 83 percent of patients that had improved by more than one NYHA functional class at 30 days. All hemodynamic outcomes were assessed and reported by an independent imaging core laboratory and were sustained over time.
The fully repositionable and retrievable Direct Flow Medical system is indicated to treat patients with severe aortic stenosis who are at 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 “in situ” repositioning of the valve after full deployment.
“The 24-month DISCOVER results demonstrate that the initial clinical improvements seen with the Direct Flow Medical valve translate into exceptional long-term outcomes,” said Colombo. “This next-generation TAVI device is the first to report such outstanding results treating an extremely sick patient population.”
The DISCOVER CE Mark Trial is a prospective, multi-center 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 Direct Flow Medical system also avoids both rapid pacing of the heart during deployment and post-dilatation following placement, minimizing the risk of hemodynamic instability for patients. It 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 system received CE Mark in January 2013. It is currently available commercially in Europe and enrolling a pivotal investigational device exemption (IDE) trial in the United States.
For more information: www.directflowmedical.com