Direct Flow Medical, a developer of transcatheter heart valve technologies, has met its primary endpoint in the Discover CE Mark Trial by achieving 99% freedom from all-cause mortality at 30 days.
The prospective, multicentre trial, which was conducted at nine European sites, enrolled 100 patients with severe aortic valve stenosis who require replacement of their aortic valve but are considered extreme risk for open surgery.
The average age of patients enrolled in the trial was 83.1 years, with a mean logistic euroSCORE of 22.5%.
For the trial, patients were treated with the Direct Flow Medical Transcatheter Aortic Valve System, and it showed positive results with regard to 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).
In the trial, 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.
The hemodynamic results were then reviewed and reported by an independent imaging core laboratory.
VARC stated that the combined safety rate was 89% and the device success rate was 91%.
During the 30 day-period, cases of two strokes were reported - major or minor, and one patient suffered with myocardial infarction.
Further, there were only two major vascular complications, even with accessing vessels as small as 5.2mm, and none of the patients required rapid pacing during deployment or post-dilatation following deployment, reducing the risk of hemodynamic stress.
At the end of 30 days, 83% of patients had improved by more than one New York Heart Association (NYHA) functional class, while 68% were categorised as NYHA Class I.
Hamburg-located Medical Care Centre 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.
Professor Schofer presented the results at EuroPCR.
The Transcatheter Aortic Valve System, which received the CE Mark in January 2013, is available commercially in Europe.