MSI has partnered with Protomed SA to provide heart valve testing services. Tests are performed within a quality system that complies with ISO 9001 and ISO 13485 standards as well as GLP requirements.
Hydrodynamic testing and assessment of heart valve hydrodynamic performance is available for cardiovascular implants that are covered under ISO 5840 (Cardiovascular implants – Cardiac valve prostheses). Heart valves are tested under steady and pulsatile flow conditions to determine flow characteristics across the valve with blood analog.
Accelerated Wear and Tear (AWT) testers can be used to assess valve durability under various pressure conditions. Each fatigue tester can test up to six samples in separate chambers, using a swash plate drive system. As the swash plate rotates, the bellows compress and extend, causing fluid to flow through the test chamber. Blood-analog fluid is dispersed into separate chambers, which enables independent pressure tuning. Tests are run under controlled, stabilized temperature.