INTEGRAL MANUFACTURING PROCESS
The entire manufacturing process of Sorin Group biological valves is the result of different working phases each of which apply a wealth of knowhow and technological expertise, acquired through decades of research and development. Unique design solutions and high technology processes have propelled Sorin Group to the forefront of the market in biological heart valve prostheses.
Bovine Pericardial Tissue Selection
Pericardial sheets are selected by thickness and other key criteria (i.e.: sheets with inflammation, vessels and "trauma" are rejected).
Bovine pericardial tissue is treated with glutaraldehyde at low-pressure fixation.
Stent Application (stented models only)
Polyester fabric is sutured to the resin stent. Pericardial sheets are then assembled and stitched to the covered stent.
Functional inspection is carried out on the valves to check opening and closing characteristics. Film footageand still pictures are shot for every valve and are archived to meet quality requirements.
Detoxification Process (Sorin Biomedica Valves)*
The valve is detoxified by means of Homocysteic Acid (HA). Aldehyde residues (GA) from the fixation process are linked with homocysteic acid to make the pericardial tissue non toxic.
Holder Application and Final Packaging
The valve passes through the final inspection and then the holder is mounted onto the valve. Final Packaging is performed in isolators to protect the valves from possible contamination. After packaging, each valve jar lid is tightened to ascertain the absence of leakage.
* This process does not apply to USA marketed biological valves