Vascular Prostheses Testing
for Cardiovascular Devices
Vascular prostheses — including synthetic grafts and stent-grafts — are vital implants used to restore or replace damaged blood vessels. They provide life-saving solutions for patients with aneurysms, arterial disease, or traumatic vascular injury. Because they directly interact with the circulatory system, vascular prostheses must undergo rigorous validation to ensure long-term safety, durability, and biocompatibility.
At our laboratory, we deliver comprehensive testing services for vascular prostheses, helping manufacturers demonstrate performance and compliance with international standards and regulatory guidance.
- Mechanical Integrity: Evaluation of tensile strength, burst pressure, and fatigue resistance under physiologically relevant conditions.
- Hemocompatibility: Assessment of blood-material interactions to minimize hemolysis, platelet activation, and thrombogenicity.
- Flow Performance: Measurement of hydraulic resistance, compliance, and lumen patency to ensure stable circulation.
- Durability & Aging Studies: Long-term testing to confirm structural stability and material resilience over extended implantation periods.
- Regulatory Documentation: Comprehensive reporting aligned with ISO and FDA requirements to support CE and global approvals.
- Advanced Instrumentation: High-resolution flow visualization and monitoring (sensor-based bubble counting) for precise cavitation detection.
- Performance Assurance: Rigorous testing confirms vascular prostheses meet clinical demands in diverse operating environments.
- Design Optimization: Data-driven insights guide improvements in graft materials, coatings, and structural design.
- Accelerated Market Access: Compliance-driven testing streamlines regulatory pathways and builds confidence with clinicians and stakeholders.
By combining advanced instrumentation, expert analysis, and strict adherence to international standards, we help manufacturers validate the safety and performance of their vascular prostheses. Partnering with us means confidence in compliance, innovation, and patient protection.