Reduced regurgitation with transcatheter aortic valve system

SANTA ROSA, CA – Direct Flow Medical, Inc. has announced the results of its DISCOVER CE Mark Trial for its Transcatheter Aortic Valve System. The company announced that the device met its primary mortality endpoint and that greater than 95% of the patients had mild or less aortic regurgitation. Furthermore, no patients experienced vascular complications.

The DISCOVER Trial is a prospective, multicenter study, which involved up to 100 patients with severe aortic valve stenosis from 10 European sites. The patients required replacement of their native aortic valve, but were at extreme risk for open surgical repair. The transcatheter aortic valve studied is endovascularly delivered via an 18F introducer sheath.

The results of the study were presented at the Transcatehter Cardiovascular Therapeutics (TCT) Conference in Miami Florida by co-principal investogator Joachim Schofer, M.D., Medical Care Center, Hamburg, Germany. All patients were successfully treated via a transfemoral approach using the low profile, flexible Direct Flow Delivery System. The freedom from all-cause mortality after 30 days was 97%, while the freedom from cardiovascular mortality after 30 days was 100 percent.