Researchers at Northwestern's Bluhm Cardiovascular Institute in Chicago recently completed a successful test of a prosthetic aortic heart valve on their first participant. Direct Flow Medical, Inc. (Santa Rosa, Calif.) developed the non-metallic investigational catheter to be placed in the heart, inserted through a blood vessel in the groin, and then navigated into the heart’s aorta. By undergoing Transcatheter Aortic Valve Replacement (TAVR), individuals afflicted with aortic stenosis--the narrowing of the valve--can avoid the high-risk procedure of open heart surgery.
Using Direct Flow’s polymer device on a patient provides an alternative to a traditional metal stent frame. The catheter’s support structure consists of an inflatable conformable cuff that prevents leaking. Two inflatable rings are at each end of the valve, and are connected by multiple inflatable bars; a polyester fabric sleeve covers the bars, and surrounds the heart valve. The valve’s inflatable rings and adjoining bars are filled with a liquid plastic polymer that hardens once the valve fits into place.
The clinical trial was named SALUS after the Roman goddess of health and prosperity.
Watch the video below for a close-up view of the deployment of the prosthetic aortic heart valve.