Morges, Switzerland, and Irvine, California, 7 February 2008 – Leman Cardiovascular (“LCV”), a Swiss biomedical device company focused on developing the third generation of heart valve, announced today that 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 maximize 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 Pr. R. Bianco, Head of the world-renowned Experimental Surgical Department of the University of Minnesota and expert in cardiac valve testing, who has been involved in the development of many other valves still on the market today. “LCV has a great valve.” Professor Bianco has no conflict of interest with Leman Cardiovascular SA.
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.”
The valve design is based on an innovative concept invented by a heart surgeon – Professor A. Kalangos, Head of the Department of Cardiac Surgery at University Hospital of Geneva, Switzerland - and developed together with heart valve experts. The design is protected by three patents and combines all the advantages of biological stented and stentless valves without their disadvantages, providing ease of implantation with high performance.
Some half a million patients suffer from heart valve disease worldwide and it is expected that by 2010 the number of patients will exceed 600,000. The cardiovascular market worldwide is estimated at USD 20 billion; of this, the heart valve replacement market represents USD 1 billion.
Leman Cardiovascular, a biomedical device company with offices in Switzerland and in the United States, was founded in 2004 to develop, manufacture, and market cardiovascular surgical devices. The Company has raised 20 million US$ to fund the project. The US subsidiary of the company – Hancock Jaffe Laboratories Inc., Irvine, California - markets the ProCol® Vascular Bioprosthesis for the creation of a bridge graft in patients with end-stage renal disease requiring vascular access for dialysis in the US and develops different types of biological devices. For more information see www.lemancardiovascular.com and www.hancockjaffe.com.
For further information, please contact:
Europe Genevensis Healthcare Communications Danièle Letoré-Castle Tel. +41 22 779 0620 Mail: info@genevensis.com
USA Wilder Communications Inc Lisa Wilder Tel. +1 919 349 3357 Mail :lisa@wildercommunications.com
