The M6 is an accelerated durability tester designed for heart valves, with modular test sections which can be modified for a variety of medical devices and materials. It’s hard to beat the fact that the M6 has at one time or other been used to test nearly every heart valve available for implant in the world today. Pioneer Professor Milton Swanson (our founder), considered by many to be the world’s first true cardiovascular flow dynamicist, introduced this instrument using a combination of a bellows volume drive with tuned fluid oscillation. This allows the heart valves to be opened and closed fully while attaining targeted closing pressures without the need to completely stop a column of liquid.
Another important characteristic is that the systemic pressure of the M6 can be raised to reduce the occurrence of cavitation during high speed testing, a particular problem with mechanical heart valves. In addition to evaluating the durability of heart valves, the M6 can be used to evaluate a variety of films, candidate leaflet materials, septal repair products and LVAD bladders. A recent regulatory requirement pertaining to how heart valves may be tested makes the selection of the right heart valve tester easier for you. Section 18.104.22.168 of ISO/AAMI 5840-3:2013 states: One equivalent size reference valve shall be tested under identical hydrodynamic loading conditions for each valve tested.
The M6, unlike other machines that feature ‘independently tuned’ test valves, is the only commercially available heart valve tester that offers identical hydrodynamic loading conditions for all valves by using tuned fluid oscillation. Tuned fluid oscillation eliminates the need for manual adjustment of individual test sections that is seen in competitive units. To learn more about how the M6 can meet the regulatory requirements of ISO 5840, and why it is still the gold standard in heart valve testers.