A Medical Device Daily

Leman Cardiovascular (LCV; Morges, Switzerland), which is focused on developing a third-generation heart valve, said 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.

The company said results of testing showed increased performance over other products, less energy loss in blood cardiac throughput and a 100% survival rate at 90 days.

LCV said its 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 company said the new data show that animals in which the LCV valve was implanted show an average of 120% increase in hemodynamic studies over existing stented valves.

“The animal study results are really very encouraging and show the product holds strong promise,” said Richard Bianco, head of the experimental surgical department at the University of Minnesota (Minneapolis) and an expert in cardiac valve testing, who has been involved in the development of many other valves on the market today.

The company said the study was conducted according to ISO/FDA 5840:2005 norms and 100% of the animals operated upon survived; moreover, they showed 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 a concept invented by heart surgeon Afksendiyos Kalangos, MD, head of the department of cardiac surgery at University Hospital (Geneva, Switzerland), and developed together with other heart valve experts.

The design is protected by three patents, LCV said, 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 global heart valve replacement market is estimated at $1 billion, Leman Cardiovascular said.

The company was founded in 2004 to develop cardiovascular surgical devices and has raised $20 million in financing to date.

The U.S. subsidiary of Leman Cardiovascular, Hancock Jaffe Laboratories (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 U.S., and is developing other types of biological devices.

Partnership on slide-stainer instruments

bioMérieux (Marcy L’Etoile, France) and Wescor (Logan, Utah) have signed an agreement under which bioMérieux will become Wescor’s exclusive worldwide partner for marketing two customized slide-stainer instruments for Gram bacillus and tuberculosis bacillus under the bioMérieux brand.

The French firm said this OEM agreement, reinforces its leadership position in the microbiology laboratory, “bringing automation to a new step in the analytic process with the unique slide-staining technology, Previ Color Gram and Previ Color TB.

bioMérieux said Gram staining is a critical and mandatory test performed in the microbiology laboratory. It is a preliminary step used to differentiate Gram-positive and Gram-negative bacteria. traditional Gram staining is “a cumbersome and long procedure, [requiring] technical expertise, numerous manual steps and therefore lacks reliability and reproducibility.”

The companies said Wescor’s automated spray technology “saves time and enables standardization and accuracy of results.”

They said the addition of the Cytopro rotor to the slide stainers results in a cytocentrifugation with eight-slide capacity. “The innovative technique also improves laboratory workflow and generates significant savings for laboratories of all sizes,” bioMérieux said. Commercial launch is scheduled for 3Q08.

“This very promising partnership with Wescor further advances bioMérieux’s strategy to enhance microbiology laboratory automation. From having two microbiology instruments [in] mid-2006, bioMérieux will be offering six microbiology instruments to customers in summer 2008,” said CEO Stéphane Bancel. “The Previ Color Gram and Previ Color TB consume less reagents than other current methods, also contributing to our company’s commitment to sustainable development.”

Wescor is part of privately held ELITech (Puteaux, France).

Benelux distribution set for BodyTel system

BodyTel Scientific (Jacksonville, Florida), a maker of wireless telemedical devices, said that it has, through its wholly owned subsidiary, BodyTel Europe, entered into an international distribution agreement with TeleHealth Services, a well-known distributor of medical supplies in the Western European Benelux region.

Beginning in the current quarter, TeleHealth Services will begin offering BodyTel’s blood glucose monitoring and diabetes management system, GlucoTel, as well as the PressureTel blood pressure device and the WeightTel weight scale, once available, in the Benelux region, which consists of Belgium, the Netherlands and Luxembourg.

BodyTel granted TeleHealth Services the right to exclusively market the products of BodyTel in the Netherlands and non-exclusive in Belgium for a term of one year. TeleHealth Services also is responsible for all distribution, compliance and marketing costs relating to the sale of the products in the distribution territory.

“TeleHealth Services has excellent know-how in the targeted markets, as well as extensive experience in selling diabetes products. We’re convinced that our new partner will play a key role for BodyTel in the coverage of the entire Benelux region,” said Michael Berrendorf, sales director EMEA for BodyTel.