May 28, 2013 — Direct Flow Medical Inc. said it met its primary endpoint in the fully-enrolled, 100-patient DISCOVER CE mark clinical 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, M.D., 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 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 46 mmHg, 14.1 mmHg 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 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.
For more information: www.directflowmedical.com