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Clinical trials move heart sensors one step closer to commercialization

T.J. Becker
Research News

CardioMEMS, a member of Georgia Tech’s Advanced Technology Development Center (ATDC), is pioneering a new breed of testing devices to monitor heart patients. Combining wireless communications technology with microelectromechanical systems (MEMS) fabrication, CardioMEMS’ products provide doctors with more information, while making testing less invasive for patients.

 
 

Deborah McGee of CardioMEMS examines an EndoSensor in the company’s clean room facility in the ATDC Biosciences Center located in the Environmental Science and Technology Building. The sensor is implanted to measure pressure in an aneurysm being treated by a stent graft.

In June, the U.S. Food and Drug Administration (FDA) approved CardioMEMS’ investigational device exemption, which enabled the company to begin clinical trials for its EndoSensor.

The EndoSensor measures blood pressure in people who have an abdominal aortic aneurysm, a weakening in the lower aorta. This condition ranks as the 13th leading cause of death in the United States. If the aneurysm ruptures, a person can bleed to death within minutes.

Doctors can treat the aneurysm with a stent graft, a slender fabric tube placed inside the bulging artery to brace it and relieve pressure by creating a channel for blood flow. Still, the stent can fail, resulting in leakage of blood into the aneurysm, which can cause the aneurysm to burst. For this reason, lifetime monitoring is required.

Safer, easier testing

Up to now, doctors have relied on CT scans for testing, but CT scans have limitations. “One problem is that CT scans only show the size of the aneurysm,” explains David Stern, CardioMEMS’ chief executive. “Yet pressure, which is what our device monitors, is the most important measurement.”

CardioMEMS’ biocompatible sensor, which is implanted along with the stent, monitors the stent more effectively than CT scans. It’s also cheaper and more convenient: the physician waves an electronic wand in front of the patient’s chest to activate the EndoSensor, which takes pressure measurements and relays the information to an external receiver and monitor.

CardioMEMS conducted its first implants at the Cleveland Clinic in July. By the end of December, approximately 100 patients in four countries had received sensors. CardioMEMS will submit resulting trial data to the FDA early this year, and hopes to receive permission to start selling the EndoSensor by mid-2005.

“Our trials show the EndoSensor is safe and producing good data,” reports Stern. “Doctors are enthusiastic because the sensor is very easy to use even though it’s complex technology.”

CardioMEMS was co-founded by Jay Yadav , a cardiologist and director at the Cleveland Clinic Foundation, and Mark Allen, a professor in the 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 that they could adapt the technology to monitor heart and blood pressure in humans.

MEMS technology uses micro-machining fabrication, which was originally developed for the integrated circuit industry to build electrical and mechanical structures at the micron scale (one-millionth of a meter).

Admitted to ATDC in 2001, CardioMEMS has grown to 30 employees. “ATDC has given us access to a range of personnel and facilities that have been instrumental to our success,” Stern says, noting that one-third of the company’s employees are either Georgia Tech graduates or students working part-time.

 

 

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Last Modified: February 21, 2005