First Patient Enrolled in SALUS Trial at Northwestern for Movable, Non-Metallic Heart Valve
CHICAGO – October 9, 2013 — Northwestern’s Bluhm Cardiovascular Institute has enrolled its first participant in SALUS, a clinical trial studying the effectiveness of a prosthetic aortic heart valve that can be placed without open-heart surgery. The heart valve under study, the Direct Flow Medical Transcathether Aortic Valve System manufactured by Direct Flow Medical, Inc., is a non-metallic, investigational device specifically designed to be placed inside the heart using a catheter that is inserted through a blood vessel in the groin and then navigated into the aorta to the heart. The study valve is also designed to have the unique ability to be repositioned or even replaced with a different size after the valve’s initial placement to achieve a better fit if one is needed.
SALUS is the first U.S. clinical trial of the Direct Flow Medical Transcathether Aortic Valve System, and will seek to evaluate how well the test valve can be delivered and its effectiveness once it is in use. Northwestern’s enrollment is the first in Illinois and the fourth institute in the country to enroll subjects.
The only transcatheter heart valve that is commercially available in the United States requires larger catheters than the study valve, sits within a metal ring, and cannot be repositioned or replaced once it is released from the catheter.
Instead of using a metal stent frame, the Direct Flow Medical Transcathether Aortic Valve System’s polymer support structure uses an inflatable, conformable cuff that has the ability to provide a better seal and prevent leaking. The study valve is composed of two inflatable rings at each end that are connected by multiple inflatable bars, all of which are covered with a polyester fabric sleeve and surround the heart valve itself. During a procedure, the study valve’s inflatable rings and connecting bars are filled with a liquid plastic polymer that hardens to a solid after it has been fitted to further help prevent leakage around the valve.
The SALUS clinical trial seeks to enroll up to 30 participants and its expected duration is five and half years, when the last participant finishes his or her follow-up period. To learn more about the SALUS trial, please call the Bluhm Cardiovascular Institute Clinical Trials Unit (CTU) at 312-695- 1806 or email firstname.lastname@example.org.