Preclinical Trials Generate Critical Improvements to St. Jude Medical’s CardioMEMS HF System

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“Our experience with T3 Labs for the CardioMEMS device created new knowledge and refinements to the device that resulted in a product that was highly mature at the time we started our clinical trials in humans.” Jason White, Senior Director of Product Development, St. Jude Medical.

St. Jude Medical turns to T3 Labs to recreate real world operating conditions for preclinical trials of CardioMEMS HF system

For arguably the most important stage in the medical product development lifecycle, St. Jude Medical called upon T3 Labs to conduct preclinical trials for the first wireless device implanted in the pulmonary artery to monitor pulmonary artery pressures. The goal for the CardioMEMS HF sensor: reduce heart failure readmissions and improve quality of life for the 1.4 million Americans suffering from NYHA class III heart failure.

During preclinical research, T3 helped St. Jude refine the system’s sensor from being attached to the right ventricular septum with an anchor coil to being placed in the distal pulmonary artery passively anchored by wire loops. The new attachment site made the sensor easier to use during the implant procedure and provided improvements in long-term safety.

“Our experience with T3 Labs for the CardioMEMS device created new knowledge and refinements to the device that resulted in a product that was highly mature at the time we started our clinical trials in humans,” said Jason White, St. Jude Medical senior director of product development.

“The T3 Labs team possesses high levels of capability with vascular procedures and state-of-the-art equipment and facilities providing solid, real world operating conditions.”

T3 has invested in 7 state-of-the-art procedure areas including 3 operating rooms on par with the top hospitals in the country.

Read the full case study of T3 Labs’ preclinical work with St. Jude Medical’s CardioMEMS HF system here.

For more information about how T3 Labs can maximize your investment in preclinical trials for medical device development, contact info@t3labs.org or call 404-894-5227.