Leman Cardiovascular ("LCV"), a Swiss biomedical device company
focused on developing the third generation of heart valve, announced
today 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(R) 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.
