CardioMEMS gets past FDA and into patients
Cardiovascular disease kills vast numbers of people and comprises a large share of America’s healthcare expenditures. As a result, technologies that can solve difficult and expensive issues in cardiac care have a bright future, and CardioMEMS is zeroing in on some of the biggest problems. The Atlanta-based company makes the EndoSure sensor, the first wireless, battery-free, permanently implantable pressure sensor approved for human use in the United States.
In November 2005 the sensor received its first FDA approval - to measure pressure changes within an abdominal aortic aneurysm, a potentially deadly bulge in a major artery that supplies blood to the abdomen.
CardioMEMS’ wireless pressure sensor is implanted along with an arterial stent. Photo courtesy of CardioMEMS
Currently, stents with a fabric coating are implanted within the artery to create a sort of tube-within-a-tube. When functioning correctly, the blood flows through the tube and the pressure on the arterial wall is alleviated. However, leaks appear periodically when blood finds its way around the stent, putting pressure back on the damaged wall.
The sensor is implanted in the artery with the stent in order to make sure no such leaks occur. The physician places an antenna on the patient’s abdomen and activates the sensor using low power radio-frequency energy. The sensor responds with a signal, and a monitor displays a real-time, high-resolution pressure waveform.
Other applications wait in the wings. The sensor has been used in heart transplant patients in Chile to measure heart function and help with post-operative care. Also in Chile, the company is conducting clinical trials to see whether the sensor is useful for managing patients with congestive heart failure, one of the costliest chronic diseases.
Managing congestive heart failure patients means tracking how strongly their hearts are pumping blood; when the heart flags, fluid buildup can quickly put a patient in the hospital. Currently, that tracking is done with clumsy tools like monitoring a patient’s weight and sending a nurse to the home to take vital signs. An implanted pressure sensor would relatively inexpensively provide early warning signs of heart failure, allowing healthcare providers to adjust the patient’s medication and avert a crisis.
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