Medical Transcatheter Aortic Valve Fares Well in Clinical Study
Published date : 06 November 2012
Article date : 06 November 2012
Medgadget reports on promising results arising from a clinical study of Direct Flow Medical's Transcatheter Aortic Valve System. They say that the device achieved its primary mortality endpoint and that over 95% of patients had mild or less aortic regurgitation. No patients experienced vascular complications.
The valve is made of a polymer frame, bovine pericardium leaflets and 2 inflatable rings that sit on both sides of the patient’s own valve. The rings can also deflate and the valve can be repositioned for a better fit or removed if complications occur.
The system is delivered endovascularly via an 18F introducer sheath. Apparently, during the trial, all patients were successfully treated via a transfemoral approach using Direct Flow Delivery System. The primary endpoin - freedom from all-cause mortality from procedure to 30 days - was met at 97%. Freedom from all cause cardiovascular mortality at 30 days was 100%. they say that the valve resulted in 97% mild or less aortic regurgitation.
Source: Medgadget.com, 02 November 2012.
Read the full article here.
