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Process of decellularization

Using a proprietary glutaraldehyde-free process, the heart valves are decellularized and sterilized. This technique reduces the residual DNA content to a minimum and RNA is no longer detectable. Therefore a transmission of pathogenic germs, like the porcine endogenous retrovirus (PERV), is impossible. The complete removal of the xenogenic cells guarantees no immunoreaction against the tissue.

The source material is of animal origin with xenogenic cells. During decellularization these cells are eliminated from the extracellular matrix in several steps. This process does not affect the extracellular matrix, which preserves the excellent mechanical properties of the tissue. Continuous quality controls accompany the complete process. 

After the process, the cell-free connective tissue structures, the extracellular matrix, remain. These are processed in further strictly controlled steps, and are prepared for clinical use and sterilized.

Immediately after implantation the autotissue implants are reseeded with the patient’s own cells. Over time, a new heart valve consisting of the patient’s own cells developes.

TÜV Zertifikat

TÜV Rheinland LGA Products GmbH certifies the admission for Matrix P plus N™, Matrix P™ as well as Matrix Patches in all sizes. Furthermore autotissue is licensed as manufacturer in accordance with EN ISO 9001:2008 as weil as EN ISO 13485:2003 + AC:2009.