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Advanced Integrity Preservation Technology Reduces Bioprosthesis Calcification While Preserving Performance and
The Journal of Heart Valve Disease
|July 18, 2015
Summary
Edwards Integrity-Preservation (EIP™) technology significantly reduced tissue calcification in bioprosthetic heart valves. Preclinical studies show EIP technology preserves valve performance and safety compared to current standards.
Area of Science:
- Biomaterials Science
- Cardiovascular Research
- Medical Device Technology
Background:
- Structural valve deterioration (SVD) is the primary failure mode for bioprosthetic heart valves.
- Edwards Integrity-Preservation (EIP™) technology aims to prevent SVD by blocking calcium-binding sites and enabling non-aqueous storage.
- This study evaluates the anti-calcification efficacy, performance, durability, and safety of EIP™ technology.
Purpose of the Study:
- To assess the anti-calcification effectiveness of EIP™ technology in bovine pericardial tissue.
- To evaluate the in-vivo and in-vitro performance and durability of valves treated with EIP™ technology.
- To determine the biocompatibility and safety of EIP™ technology for implantable devices.
Main Methods:
- Comparison of EIP™ treated tissue with industry standards (ThermaFix®, Xenologix®) using a rabbit calcification model (60 days).
- Quantification of tissue calcium content via atomic absorption spectrophotometry.
- In-vivo assessment in a 20-week ovine model and in-vitro hydrodynamic testing (effective orifice area, regurgitation).
- Accelerated wear testing (200 million cycles) and ISO-compliant biocompatibility testing.
Main Results:
- EIP™ technology significantly reduced median tissue calcium content from 81.15 to 0.43 µg/mg dry tissue (p < 0.0001).
- Valve performance, in-vitro hydrodynamics, and durability were comparable between EIP™ treated and control groups across all sizes.
- EIP™ technology demonstrated biocompatibility meeting ISO requirements for implantable devices.
Conclusions:
- Preclinical evaluations indicate EIP™ technology substantially reduces tissue calcification while maintaining valve function and safety.
- EIP™ technology shows promise as an advancement over current standards of care for bioprosthetic heart valves.
- Further human studies are warranted to confirm these preclinical findings.
