Pericarbon More Mitral Stented Pericardial Valve

The Pericarbon More mitral stented pericardial valve is the result of LivaNova ceaseless commitment to achieving superior levels of quality and reliability in medical technology. The long-term proven design1-6 of the first generation of CarbofilmTM coated Pericarbon mitral valves combined with improved implantability and exclusive tissue treatment aimed at detoxifying the valve and mitigating the calcification process are proof of the success of LivaNova’s mission:

 to improve the quality of life for patients

 • Proven clinical performance

• Robust and safe design

 • Low profile scalloped stent

• Soft, compliant sewing cuff

• Anti-looping protection

 • Ready for use, no rinsing required

• Detoxified valve

The currently available pericaldial valves, particularly the Carpentier-Edwards pericardial and the LivaNova Pericarbon, appear to provide an attractive option for the mitral valve replacement in older patients because they often out-live the patient and the need for reoperation is low. Pericardial mitral valve can also be used in younger patients but frequent monitoring of valve performance is necessary because they may become stenotic with time and require years after operation

These results show that over a period of up to 10 years, the Pericarbon pericardial bioprosthesisis an excellent and safe valve substitute.

AORTOTOMY AND NATIVE VALVE EXCISION

The exclusive detoxification treatment with homocysteic acid14, 15, neutralizes the residues of unbound glutaraldehyde groups (GA) left after the tissue fixation process. Both sheets are made of the same pericardium material, hence, the detoxification treatment acts on the leaflets and wall in exactly the same manner.

 The prosthesis is then stored in a sterile, aldehyde-free solution. The final product does not contain glutaraldehyde residues, thus the valve is ready to implant and does not require washing.

Comparative studies between detoxified and non-detoxified pericardial tissue samples show that the process maintains unchanged the tissue stability and the mechanical properties provided by the glutaraldehyde cross-linking 8 .

 In-animal testings have been conducted in order to evaluate the anticalcification effects of the detoxification treatment. Both subcutaneous implants in rats of pericardial patches and valve replacements in sheep have shown a significant reduction in calcium contents of detoxified patches and valves vs non-detoxified (glutaraldehyde treated only) patches and valves.

UNIQUE PROVEN DESIGN

 Unique two-sheet design  

The bioprosthesis is attained by the unique two-sheet design: a tricusp shaped pericardium sheet is sutured to a second flat sheet using thread coated with a thin film of turbostratic carbon (Carbofilm™). The commissural areas, designed to absorb and distribute the mechanical stress during leaflet motion, present a unique cross-stitch suturing pattern. The two sheets are superimposed in a flat position so when the leaflets open they recover their original cylindrical configuration, hence, they are completelystress-free.

The elastic chain

The unique design creates a chain of smooth linkages with decreasing elasticity and represents theideal condition for minimizing the concentration of tensional stress, especially during the closurephase. The presence of the second pericardium sheet (pericardial lining) is significant and makes the

valve unique in that:

• its use contributes to the elastic chain
• it avoids contact and abrasion between the three leaflets and the fabric covered stent(syntheticmaterial).

The fixation process

The bioprosthesis is constructed from glutaraldehyde-treated bovine pericardium. Simultaneous in-depth tissue fixation and shaping are achieved by means of a fluidic, hence atraumatic system at low pressure. The detoxification process is then applied to the valve.