CardioMEMS (Atlanta, GA), a graduate of Georgia Tech's ATDC startup accelerator, is pioneering a new class of heart monitoring devices, based on a sensor that measures intracardiac pressure in people who suffer from congestive heart failure. The company completed a successful clinical trial in May of 2010 for its second product, which resulted in a $60 million equity investment and purchase option from St. Jude Medical Inc. (St. Paul, MN).
The company grew out of Georgia Tech research, and offers products that combine wireless communications technology with microelectromechanical systems (MEMS) fabrication, providing doctors with more information while making monitoring less invasive for patients.
Launched in 2001, CardioMEMS was co-founded by Dr. Jay Yadav, a cardiologist and director at the Cleveland Clinic Foundation at the time, and Mark Allen, a professor in Georgia Tech's School of Electrical and Computer Engineering and director of the school's MEMS research group. Yadav was interested in Allen’s use of MEMS technology for microsensors that could measure pressure in turbine engines. Although Allen had designed the sensors specifically for military drone aircraft, he and Yadav believed they could adapt the technology to monitor heart and blood pressure in humans.
How it Works
MEMS uses micro-machining fabrication to build electrical and mechanical systems at the micron scale — one-millionth of a meter. Using technology originally developed for the integrated circuit industry, MEMS is an attractive platform for medical devices because mechanical, sensing, and computational functions can be placed on a single chip.
CardioMEMS began marketing its first product in 2006: the EndoSure sensor, which measures blood pressure inside a repaired abdominal aortic aneurysm. Implanted along with a stent graft during endovascular repair, this tiny sensor is designed to allow doctors to monitor post-surgery patients more effectively than the CT scans that had previously been used. The EndoSure™ AAA Wireless Pressure Measurement System measures intrasac pressure during thoracic aortic aneurysm (TAA) repair.
The EndoSure is comprised of an implanted sensor and an external electronics module. The sensor is inserted during the minimally invasive cardiovascular repair of an abdominal aortic aneurysm or thoracic aortic aneurysm via a catheter into a patient’s aneurysm sac and measures and communicates pressure information to an external electronics module from inside the sac. The information is processed in real time and displayed as a pressure waveform. The sensors are designed to measure vital medical parameters such as mean pressure, systolic pressure, diastolic pressure, heart rate, and cardiac output.
Where it Stands
Now, CardioMEMS’s second product is moving closer to FDA approval. The Champion wireless heart failure sensor is a miniature device that is implanted into the patient's pulmonary artery using a simple, catheter-based procedure. The pulmonary artery pressure is then measured and displayed using the proprietary electronic monitoring system. Following the procedure, patients perform wireless measurements of their pulmonary artery pressure from home. The pressure data is immediately transmitted to a secure database and is available for review by the implanting physician on the CardioMEMS proprietary Web site, which enables physicians to monitor patients more effectively and alter medications when necessary. Results from a recent clinical study showed a 40 percent reduction in hospitalizations when doctors used data from CardioMEMS’s system to treat patients.
The heart sensor has faced a longer road to commercialization than the company's first product; however, its market potential is dramatically larger, said David Stern, CardioMEMS’s chief executive, citing a patient population of more than 1.5 million compared to about 30,000 for the EndoSure sensor.
For more information about CardioMEMS, visit http://info.hotims.com/34459-165 .