Direct Flow Medical, a developer of novel transcatheter heart valve technologies, has announced that it has been able to meet its primary endpoint in the Discover CE Mark Trial by achieving 99% freedom from all-cause mortality at 30 days.
The trial had enrolled 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 trial was conducted at conducted at nine European locations.
For the trial, patients were treated with the Direct Flow Medical Transcatheter Aortic Valve System. The trial showed tremendous results in overall patient hemodynamics and avoidance of post-procedural aortic regurgitation and adverse events.
The Transcatheter Aortic Valve System has been developed to minimise the risk of aortic regurgitation following transcatheter aortic heart valve implantation (TAVI).
During the trial, it was found that 99% of the patients experienced mild or less aortic regurgitation, while 73% reported 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, showed that the system has been able to significantly lessen, and maintain, low gradients over time.
Hamburg-located Medical Care Center MD and trial investigator Joachim Schofer said these results are unprecedented for a TAVI device.
"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," professor Schofer added.
The Transcatheter Aortic Valve System received the CE Mark in January 2013 and is commercially available in Europe now.