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Medical Product Manufacturing News, September/October 2015

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Q M E D . C O M / M P M N M E D I C A L P R O D U C T M A N U F A C T U R I N G N E W S S E P T E M B E R / O C T O B E R 2 0 1 5 1 5 outweighed the risks, says Jason White, senior director, product development engineering for CardioMEMS. "For devices such as a pacemaker or implantable defibrillator, the benefit is more straightforward to measure because therapy is the direct effect of the device," he says. "For the CardioMEMS HF system, the benefit is observed when the data provided by the system is incorporated by the physician into the care of the patient." "The Champion trial results were pretty profound: patients for whom there had been no therapeutic sequence or strategy or medicine to help them, this was the first time that a strategy helped them stay well and out of the hospital. There was about a 50% reduction in hospitalizations, and it was statistically sound. They represented about 25% of the population in the trial," says Adamson, who helped design the trial along with Abraham, now at the Ohio State University Wexner Medical Center. The Champion clinical trial was able to demonstrate a 37% reduction in heart failure hospitalizations over a 15 month average follow-up timeframe when physicians used the device to guide patient care. "The unique challenge was demonstrating that the benefits were achieved only as a result of the data provided by the system," White says. Now that that the benefit of the technology is supported by strong clinical evidence, St. Jude may consider exploring other cardiology applications for it. The technology could be useful for monitoring chronic diseases that have a hemodynamic progression, such as hypertension, pulmonary arterial hypertension, respiratory disease, and portal hypertension, White says. There could be applications within the congenital heart disease space. "We think this technology will also be useful to optimize settings for therapeutic implants such as cardiac resynchronization therapy and ventricular assist devices." Making a Brand New Type of Cardiology Device Innovating within the cardiology device space is a complicated affair. The regulatory constraints inherent in niche medical device categories mean that many new cardiology devices never reach the U.S. market; the cost to commercialize them in the United States often outweighs the potential upswing. But developing the CardioMEMS device was made more difficult in that it was so unique from a technological perspective. For instance, the technology is powered by a RF electromagnetic field rather than a battery. The RF field is "generated by an antenna positioned in a pillow that the patient lays on each time they take a reading," White says. "This powering method means the sensor does not require a battery and the approach to gathering the data does not require precise antenna alignment with the implanted sensor. The RF energy transfers effectively through air, clothing, and the patient's body to the depth of the implanted sensor." When asked to provide words of wisdom to other device firms that are exploring using MEMS technology in their products, White says: "A medical device with MEMS technology needs to be designed with the system in mind; there are significant requirements that are not specific to MEMS technology." White explains that St. Jude's goal for future iterations of CardioMEMS technology is to continue to improve its use in helping to manage heart failure. "We expect technology advancement for heart failure patients could allow the measurement of additional parameters and improvement in monitoring capabilities," he says. Just the ability to monitor aortic pressure remotely is already transformitive in cardiology, Adamson says. "I think we will look back 10 years ago wondering how we ever managed healthcare without it. It is like the first EKG." T e current version of St. Jude Medical's CardioMEMS HF device is about the size of a paper clip.

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