Direct Flow Medical, a US-based developer of transcatheter heart valve technologies, has presented 30-day and six-month outcomes from a prospective, multicentre study of its Direct Flow transcatheter aortic valve system.
The CE-marked Direct Flow System has a distinctive heart valve with a metal-free frame, and is transfemorally delivered using a flexible 18 French delivery system.
The Discover trial, which was conducted at up to 10 European sites, enrolled 100 patients with severe aortic valve stenosis who required replacement of the native aortic valve, and were at extreme risk for open surgical repair.
At 30 days, there was 98% freedom from all-cause mortality in 54 patients.
The pre-specified CE Mark cohort demonstrated 92% freedom from all-cause mortality at six months.
Secondary endpoints had a combined safety rate of 89% and 85% respectively, at 30 days and six months
The valve academic research consortium combined device success was 96.3%, with only one major vascular complication of myocardial infarction.
San Raffaele Scientific Institute interventional cardiologist and trial investigator Dr Azeem Latib said the device is demonstrating very low mortality, sustained improvement in hemodynamics and minimal aortic regurgitation at six months.
"It is also continuing to demonstrate excellent results in a larger patient cohort," Latib said.
"The system enables us to optimise outcomes for our patients by allowing full hemodynamic assessment and the flexibility of repeated repositioning, as well as retrieval, improving the TAVR procedure and minimising risk."