FDA Compliance
Measuring Up
Combining wireless and MEMS technology to monitor blood pressure of aneurysm patients.
Published: Tuesday, July 24, 2007 - 22:00
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CardioMEMS engineer Michael Fonseca uses a laser to separate pressure sensors in the company’s clean room facility in the ATDC Biosciences Center located at Georgia Tech’s Environmental Science and Technology Building.
Photo by Gary Meek |
After winning a thumbs-up from the Food and Drug Administration, CardioMEMS Inc. has launched its EndoSure sensor, which makes testing safer and more convenient for aneurysm patients.
Based on intellectual property of the Georgia Institute of Technology, EndoSure is the first implantable pressure sensor that combines wireless and microelectromechanical system (MEMS) technology to receive FDA clearance.
“This is a significant milestone that validates our product is safe and relevant,” says David Stern, CardioMEMS’ chief executive, noting that the FDA based its 510(k) clearance on results from an international clinical study involving more than 100 hospital patients in the United States, Brazil, Argentina, and Canada.
Better results, less hassle
Officially known as the EndoSure Wireless AAA Pressure Measurement System, CardioMEMS’ device measures blood pressure in people with an abdominal aortic aneurysm. Ruptures from this weakening of the lower aorta rank as the 13th leading cause of death in the United States. Although doctors can treat the bulging artery with a stent graft, stents can fail, so aneurysm patients require lifetime monitoring.
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Deborah McGee of CardioMEMS prepares a batch of the company’s pressure sensors for a final cleaning step. Photo by Gary Meek |
Yet, traditional testing methods such as computed tomography (CT) scans, are expensive and time-consuming. What’s more, CT scans are limited in scope because they only reveal the size of an aneurysm. In contrast, the EndoSure monitors pressure inside the aneurysm sac—the most important measurement for doctors to know.
Easier testing for doctors and patients.
About the size of a paper clip, the EndoSure sensor is implanted along with the stent graft during endovascular repair. During checkups, patients don’t need to remove clothing: Doctors merely wave an antenna in front of the patient’s chest, and low-power radio-frequency waves activate the EndoSure system, relaying pressure measurements to an external receiver and monitor.
“Initial demand is extremely encouraging, and we’re working hard to get the product out to our new customers,” says Stern, noting that EndoSure is compatible with all commercially available stents.
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| CardioMEMS’ EndoSure sensor makes testing safer and easier for aneurysm patients. |
MEMS uses micromachining fabrication to build electrical and mechanical systems at the micron scale—one-millionth of a meter. Although MEMS was originally developed for the integrated-circuit industry, it’s an attractive platform for medical devices because mechanical, sensory, and computational functions can be placed on a single chip.
CardioMEMS is already extending its core technology to other products. In the works are:
- A sensor that measures intracardiac pressure in people who suffer from congestive heart failure. After successful testing on animals, clinical trials began in February with a successful implantation in a patient’s pulmonary artery in Santiago, Chile.
- A sensor that measures blood pressure in patients with thoracic aorta aneurysms.
- Devices to help hypertension patients monitor their condition at home and adjust medication.
Among startups formed from university research, CardioMEMS has been one of Georgia Tech’s biomedical pioneers. “The fact that CardioMEMS is starting to gain traction shows how the school’s investment in bioscience resources and infrastructure is starting to pay off,” says Kevin Wozniak, associate director of Georgia Tech’s Office of Technology Licensing.
This article was originally published in Research Horizons magazine, a publication of the Georgia Institute of Technology.
About the author
T. J. Becker is a former science and technology writer for the Georgia Institute of Technology’s Research News & Publications Office.
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