Artificial heart valves must remain durable and biocompatible throughout years of continuous operation. One of the most critical long-term risks is calcification — the deposition of calcium salts on valve leaflets and supporting structures. Calcification can impair valve flexibility, increase regurgitation, and ultimately lead to device failure. Rigorous testing is therefore essential to validate valve durability and patient safety.
At our laboratory, we conduct calcification testing under internationally recognized protocols, providing manufacturers with the data needed to demonstrate reliability and compliance.
- Accelerated In Vitro Models:
Simulation of physiological conditions to evaluate calcium deposition over time. - Quantitative Analysis:
Measurement of mineral accumulation, leaflet stiffening, and changes in hydrodynamic performance. - Material Evaluation:
Assessment of biomaterials, coatings, and design features that influence calcification resistance. - Regulatory Documentation:
Comprehensive reporting aligned with ISO 5840 and related standards to support FDA, CE, and global approvals.
- Patient Safety:
Preventing calcification ensures valves maintain proper function and reduce risks of reoperation. - Performance Assurance:
Long-term durability testing confirms valves deliver consistent hydrodynamic performance. - Design Optimization:
Data-driven insights guide improvements in biomaterials and anti-calcification strategies. - Accelerated Market Access:
Compliance with international standards streamlines regulatory pathways and builds confidence with clinicians.
By combining advanced test systems, precision analytics, and strict adherence to global standards, we help manufacturers validate the long-term safety and reliability of their artificial heart valve prostheses. Partnering with us means confidence in compliance, innovation, and patient protection.