Transcatheter heart valve company Direct Flow Medical®, Inc., has 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.
Our readers will probably be familiar with it by now, but for those who aren’t, the Direct Flow Medical Transcatheter Aortic Valve System is designed to minimize the risk of aortic regurgitation following transcatheter aortic valve implantation (TAVI). 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 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. Study results, presented at this weeks EuroPCR event in Paris, showed 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 Direct Flow Medical system received the CE Mark in January 2013 and is currently available commercially in Europe.