Biomaterials and Tissue Engineering CIC

Koehler Medical is the only UK-based heart valve manufacturing company. Having noted the increasing age profile of heart valve replacement patients, Koehler saw the need to develop a new type of valvular prosthesis. This would address both the aortic stenosis and sclerosis common in older patients; estimated to affect 150,000 patients by 2020.

Koehler's solution was to propose a world first: to supply a stentless biological valve in an artificial conduit. A stentless biological valve is generally porcine, similar in every important way to our own and completely free of artificial parts. The man-made conduit came from a partnership with Vascutek Terumo, and is malleable yet retains its shape when fitted.

The need to ensure that this prosthesis would perform properly is obvious. The wet material of the biological valve had to attach to the dry material of the conduit to leave a functioning prosthesis opening and closing 40 million times a year without causing harm or reaction. Koehler approached the Biomaterials and Tissue Engineering CIC (BITECIC) for help. The aim was to refine the device design and quantify the function of the prosthesis, in order to gain CE marking to show conformity with European health and safety requirements.

The BITECIC combines state-of-the-art facilities and commercial know-how with the world-class expertise of over 100 researchers. This also includes the active involvement of clinical collaborators at university hospitals. The centre tested the product against the competition and found its performance to be far superior.

The findings were fed back into the design process to further refine the product into a marketable form. Today, the new BioValsava has already been implanted into patients with excellent results, with the main product launch scheduled for September 2007. It is already provoking intense interest in the worldwide surgical community, and helping to enhance Koehler's reputation as innovative and technologically advanced. Future collaborative work is planned to expand use of the product into specialist markets such as paediatrics.

For further information visit:
www.koehler-medical.com
www.bitecic.com

Benefits of Koehler Medical's collaboration with the Biomaterials and Tissue Engineering CIC:

• CE marking approval received
• Confidence gained with development partners and surgeons
• Increased share in existing, high-growth market
• Reduced R&D timescales ensuring first to market