Swiss biomedical device company Leman Cardiovascular (LCV), has announced that it has successfully completed animal studies to evaluate the in vivo safety, performance, healing and handling characteristics in both the aortic and mitral positions of its heart valve.
Testing was carried out in compliance with ISO/FDA standards. Results showed increased performance over other products, less energy loss in blood cardiac throughput and a 100% survival rate at 90 days.
The LCV heart valve is designed to maximise blood flow and requires less work to accommodate any given cardiac output. The internal supports are placed in a manner to achieve a restoration of the native anatomy at the inflow of the valve; this allows the stress-free preserved leaflets to function in a manner mimetic of a natural valve.
The new data show that animals in which the LCV valve was implanted show an average of 120% increase in haemodynamic studies over existing stented valves.
“The animal study results are really very encouraging and show the product holds strong promise,” said Professor R Bianco, Head of the Experimental Surgical Department of the University of Minnesota and a specialist in cardiac valve testing. “LCV has a great valve.”
The study was conducted according to ISO/FDA 5840:2005 norms and 100% of the animals operated upon survived, moreover showing a faster recovery than usually observed.
“In this study we demonstrated that LCV’s third generation heart valve delivers in terms of performance, flow characteristics and durability,” said Benedict Broennimann, CEO of Leman Cardiovascular.
“The procedure with our valve is shorter than average. The next step will be first in man, which we plan to do by the end of the first semester 2008.”