Cell-free
Human Heart Valves

Regenerative heart valves

Decellularization techniques have created a new generation heart valve, which can overcome the limitations of biological and mechanical heart valves due to remodeling, regeneration and growth potential. A heart valve consists of a stable and elastic connective tissue, which is lined and colonized by cells. The mechanical properties of a valve are achieved by the connective tissue, whereas the cells provide continuous regeneration and adapted growth. Heart valves can be treated with detergents to wash out the cells. The mechanic function of the valve is retained, because the connective tissue is not damaged. The cell-free tissue produces a stable graft which can be easily stored, shipped and handled. While transplanted cells can trigger rejection by the recipient, the connective tissue is well tolerated. The transplanted cell-free tissue is colonized by the cells of the recipient, providing the basis for healing and autologous regeneration.

Process

The ‘Decellularized Human Pulmonary Valve, Espoir PV’ and the ‘Decellularized Human Aortic Valve, Arise AV’ are derived from homografts where somatic cells are completely removed. Our proprietary decellularization process has disinfectant effects. Cell-free homografts have many advantageous characteristics including less immunogenicity, negligible calcification and excellent clinical outcomes.
logos espoir arise

Cell-free heart valves can be delivered exclusively to physicians. The access to and allocation of those valves is subject to very different regulations across Europe. Please contact corlife for further information.

Corlife voluntarily supports surveillance studies to determine the regenerative potential of the heart valve substitutes (www.espoir-clinicaltrial.eu, www.arise-clinicaltrial.eu), which is funded by the European Union (FP 7: #278453, Horizon 2020: #643597). The European institution www.encepp.eu has awarded the seal for robust methodologies, transparency and scientific independence for both studies. So far, clinical outcome in terms of freedom from explantation, maximum gradient and regurgitation has been excellent.

 

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