Cardiovascular

Heart Failure

Here's what makes heart failure devices challenging. Your LVAD must pump continuously for years without forming clots or damaging blood cells. Your bypass system needs to maintain circulation without destroying cells during long procedures. We help you prove your device works reliably when failure isn't an option.

Our Heart Failure Expertise

Heart failure devices have to be reliable. Period. Your LVAD must pump continuously across varying conditions without causing clots, destroying blood cells, or getting infected. Temporary support systems need rapid deployment and stable performance during crises. Bypass circuits require efficient gas exchange without cell damage. Each platform has distinct challenges.

We test pump performance using pressure volume loop analysis. This captures how your device interacts with the struggling ventricle. Our cath labs have mock circulation systems that replicate both normal and failing heart states. We measure cardiac output, ventricular pressure, and echo changes under stress conditions.

Complete Heart Failure Capabilities

LVAD

Your LVAD has to keep pumping for weeks, months, or years without causing blood clots or destroying red blood cells. That's the challenge. We test continuous flow devices in failing heart conditions using pressure-volume analysis to measure device ventricle interaction. We quantify hemolysis, platelet changes, and clotting factor degradation following ISO 10993-4 standards. This gives you the Class III biocompatibility data FDA expects for bridge to transplant or destination therapy approval.

Cardiopulmonary Bypass

Your bypass system contacts blood for hours during surgery through artificial membranes. We evaluate blood cell damage, measuring hemolysis, platelet activation, and inflammatory markers that indicate biocompatibility problems. We also assess membrane surface characteristics that affect blood interaction. Our testing follows ISO 7199 standards for oxygenator biocompatibility aligned with FDA expectations. This demonstrates your system exchanges gases effectively without causing excessive blood trauma or inflammatory responses that complicate patient recovery.

Mechanical Circulatory Support

Temporary support devices deploy quickly during cardiac crises. They maintain hemodynamics while the heart recovers or until definitive treatment. Your device needs consistent performance across varying degrees of heart failure. We test flow rates, pressure support, and blood compatibility during simulated acute decompensation. We measure how quickly support can be initiated and how reliably it sustains circulation across changing patient conditions.

Myocardial Ischemia Models

Our ischemia models create controlled myocardial damage for device testing. We evaluate tissue injury patterns, measuring infarct size, cell death, and scar formation after coronary occlusion. Our pathologists assess healing progression from acute necrosis through chronic scarring using standardized histological grading. Cardiac biomarkers confirm that injury severity matches what's seen in clinical heart attacks. This creates reproducible disease conditions showing how your device performs in hearts with documented tissue damage patterns aligned with real patient pathology.

Ready to Start Your Heart Failure Program?

Let's talk about your device. LVAD. Bypass circuit. Temporary support. What it needs to prove. What pathway makes sense. We'll design a validation strategy that addresses pump performance, blood damage, and durability.

Schedule Consultation