Heart Valve Device Testing

We test complete heart valve devices, stent struts, support structures, and frames made from nitinol, braided wire, and bioabsorbable polymers. Our testing covers both surgical and transcatheter devices through specialized protocols. For stented valves, we specifically test the stent portion separately from the valve itself, evaluating high-strain portions and support structures through targeted analysis. 

We provide in vitro durability testing through mechanical fatigue, stent strut fatigue testing, heart valve frame fatigue testing, and pulsatile fatigue loading for 400M or 600M cycles. Our testing includes detailed S-N curve generation for stent struts, with specialized protocols for different device components and configurations. 

Tests we offer include: 

• Heart valve durability testing 

• Stent strut fatigue testing (S-N curve generation) 

• Heart valve frame fatigue 

• Device acceptance & failure criteria 

We deploy stents inside mock vessels with physiologically-relevant compliance and hydrodynamic pressure to accurately replicate in vivo conditions. Our testing includes load monitoring and specialized fixturing to accommodate different specimen geometries. We can test 12-15 samples simultaneously while maintaining continuous monitoring of test conditions and specimen performance. 

Heart Valve Durability Testing: 
Element conducts in vitro durability testing for transcatheter heart valves, replicating in vivo conditions with mechanical fatigue to simulate 10–15 years of physiological strain. This is a crucial step in evaluating the implant's long-term performance. 

Stent Strut Fatigue Testing (S-N Curve Generation): 
For stented valves, we test the stent strut separately under high-strain conditions using customized fixturing. Multiple samples are tested simultaneously at different strain levels to generate stress vs. cycle curves (S-N curves), providing a comprehensive assessment of fatigue durability. 

Heart Valve Frame Fatigue: 
We evaluate bioprosthetic valve frames with pulsatile fatigue testing for 400M–600M cycles, simulating real-world conditions inside physiologically-relevant mock vessels. This ensures optimal performance, longevity, and fatigue resistance. 

Device Acceptance & Failure Criteria 
Manufacturers set specific criteria for device failure or acceptance, such as stent strut continuity or absence of visible cracks under 30x magnification after testing. We monitor these criteria throughout testing and provide detailed documentation of the specimens against the predefined criteria.  We use ElectroForce test instruments for stent strut fatigue, along with visual, endoscopic, high-speed video, and strobe light inspections to assess device performance. 

We utilize ElectroForce 3200 and 3300 test instruments for precise control of test conditions, supported by comprehensive inspection capabilities including visual examination, endoscopic analysis, high-speed video capture, and strobe light analysis for detailed performance evaluation. 

Our expert team operates from strategically located medical device industry hubs, giving you convenient access to expert guidance. Find your nearest lab on our Locations Page.

We first conduct testing with physiologically-relevant vessels to determine target strains for a given stent, followed by testing with thick-walled vessels for accelerated fatigue testing. This dual-approach enables higher frequency testing while maintaining appropriate loading conditions, supporting efficient validation of long-term performance.