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News

New CardioMEMS device helps aneurysm patients

Georgia Institute Of Technology : 03 February, 2006  (New Product)
Winning a thumbs-up from the U.S. 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 from the Georgia Institute of Technology, EndoSure is the first implantable pressure sensor that combines wireless and microelectromechanical system technology to receive FDA clearance.
Winning a thumbs-up from the U.S. 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 from the Georgia Institute of Technology, EndoSure is the first implantable pressure sensor that combines wireless and microelectromechanical system 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 as well as Brazil, Argentina and Canada.

Officially known as the EndoSure Wireless AAA Pressure Measurement System, CardioMEMs' innovative device measures blood pressure in people who have 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.

Yet traditional testing methods, such as 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.

CardioMEMS also makes testing easier for both 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.

In addition to FDA clearance, CardioMEMS achieved another milestone when it closed on $16 million in financing in December. Leading this Series C round was new investor Medtronic, a Minneapolis-based manufacturer of implantable biomedical devices. Several previous investors also participated in the financing: Boston Millennia Partners, Foundation Medical Partners, Arboretum Ventures, Guidant Corp. and Johnson & Johnson Development Corp.

Outside investment in CardioMEMS now totals about $32 million, no small achievement. In fact, the company was tapped as one of the Georgia Biomedical Partnership's 'Deal of the Year' winners for 2006, an award recognizing companies that have advanced the state's bioscience industry.

Observers link CardioMEMS' success partly to its approach to commercialization. 'Instead of a technology looking for a home, CardioMEMS clearly identified a market need that required a technology solution,' points out Lee Herron, general manager of biosciences at the Advanced Technology Development Center, Georgia Tech's incubator for high-tech startups. 'When it comes to tech transfer at universities, it's often the other way around,' he explains.

CardioMEMS traces its roots to an unlikely duo: Dr. Jay Yadav, a cardiologist at the Cleveland Clinic Foundation and chairman of CCF Innovations, and Mark Allen, a professor in Georgia Tech's School of Electrical and Computer Engineering and director of the school's MEMS research group.

Having previously founded AngioGuard, a company that developed the first filter to prevent emboli during surgery, Yadav was interested in applying MEMS technology to medical devices. (MEMS uses micro-machining 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.)

Intrigued by several of Allen's published papers on MEMS, Yadav traveled to Georgia Tech to meet the engineer. Allen had already developed microsensors that could monitor the performance of turbine engines in military aircraft, but he and Yadav believed that the technology could be adapted to measure heart and blood pressure in people.

Although Allen had been involved in a previous startup, Redeon, a pioneer in micro-needle technology, CardioMEMS marked his first experience commercializing a biocompatible medical device. 'Developing an implantable sensor for humans has been very exciting,' Allen says. 'It's opened a whole new application area for me to think about where MEMS technology could go.'

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.
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