Cardiovascular
Here's what makes cardiovascular testing different. Your transcatheter valve must seal perfectly in heavily calcified tissue while preserving coronary flow. Your LVAD needs to pump continuously for years without forming clots or damaging blood cells. We help you prove your device works safely across the extreme conditions it will face clinically.
Our Cardiovascular Expertise
Your DCB has to deliver drugs while the vessel heals. Each of these devices faces unique testing challenges. Our catheterization labs replicate the conditions your device will encounter clinically.
Our 40 years of cardiology expertise have supported hundreds of studies that give FDA reviewers the evidence they need. We understand what makes cardiovascular testing different. We know what data satisfies regulatory reviewers.
Complete Cardiovascular Portfolio
Select your specific area below, or scroll down to learn more about our cardiovascular expertise and specialized capabilities.
Heart Failure
Your LVAD has to pump blood continuously without causing clots or destroying red blood cells. That's the challenge. We test how your device interacts with the failing heart. We measure pump performance and blood damage. This gives you the safety data FDA needs for life sustaining devices.
Structural Heart
Your transcatheter valve needs to deploy accurately in heavily calcified tissue. It has to seal completely. No leaks. We test deployment precision across different anatomies. We measure how well your valve performs. This shows FDA your device works in the real-world conditions it will face.
Neurovascular
Stroke devices work in the most delicate vessels in the body. Your thrombectomy system has to grab clots quickly without damaging brain tissue. Speed matters. Safety matters more. We test how fast your device restores blood flow and whether it protects fragile cerebral vessels.
Coronary Vascular
Your drug-coated balloon faces a double challenge. The drug must enter the vessel wall and be retained. The drug coating has to prevent restenosis. That means coordinating CDRH and CDER reviews. We test both the device and the drug together, giving you integrated data that satisfies both centers.
Peripheral Vascular
Peripheral devices work in larger vessels under extreme stress. Your femoral stent gets compressed every time the patient walks. Your carotid system has to navigate tortuous anatomy without causing stroke. We test durability under the real biomechanical forces these devices face.
Robotics
Your robotic system promises submillimeter precision. Reduced radiation for operators. Better outcomes. But you have to prove it. We test articulation accuracy, control responsiveness, and how well your platform performs across different procedures.
Ready to Start Your Cardiovascular Program?
Let's talk about your device. What it needs to prove. What regulatory pathway makes sense. We'll design a validation strategy that addresses your specific challenges and gets you to approval faster.
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