British Columbia-based Neovasc is developing a new transcatheter mitral valve with which they aim to overcome some of the challenges of existing prostheses. The new Tiara device is already going through animal trials and the company has announced positive results regarding ease of implantation, confidence of fixation, and overall positive hemodynamics at this week’s Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
The Tiara was developed to address the specific anatomy of the mitral valve rather than being a modified aortic valve. It is made to continuously conform to its surroundings with every heartbeat, preserving the natural shape of the valve.
From the company press release:
They reported that during these acute animal studies, the Tiara valves were implanted successfully in 81% of the test animals, with total procedure times ranging from 17 to 26 minutes. In the successful implantations, angiographic and echo imaging demonstrated excellent function of the Tiara device, with no obstruction of the left ventricular outflow tract, no pericardial effusion, no encroachment on the aortic valve,no transvalvular gradients and most importantly, no significant paravalvular leak. Researchers also reported early results from the first long-term animal implantations of the Tiara device, including echocardiogram images of Tiara valves obtained
approximately three months after implant, which demonstrated continuing good function and integrity of the valve. These chronic animal studies are ongoing.
Additionally, Neovasc reported clinical results on its Reducer implant for treating refractory angina. The Reducer actually restricts the outflow of coronary blood, effectively increasing perfusion pressure.
The Neovasc researchers reported on the experience of the first 11 patients who were implanted with the Reducer and followed for six months or more as part of the REDUCE-1 and REDUCE-2 Registries. No complications or cardiac adverse events were recorded in these patients. Clinical parameters including the patients’ angina scores and their daily consumption of nitroglycerin were diminished significantly six months after Reducer implantation. Additionally, exercise stress test parameters improved, and functional imaging of myocardial perfusion showed that blood flow in the heart improved significantly. Measures of left ventricular ejection fraction, considered a key indicator of cardiac function, alsoimproved after Reducer implantation.
Device info page: Neovasc Tiara…
Press release: Neovasc’s Tiara™ Transcatheter Mitral Valve Selected as a “Best” New Device Concept at TCT 2012 Scientific Symposium
Flashbacks: Neovasc Coronary Sinus Reducer: A Novel Stent for Ischemic Heart Disease; Neovasc Reducer Gets European Clearance as Refractory Angina Treatment