Wireless Pressure Sensors Approved, Implanted, Funded
CardioMEMS, Inc. first used its Endosure wireless implants on two human patients at the Cleveland Clinic Foundation in July 2004, and got FDA approval for these devices by the FDA last month. Now the Michael E. DeBakey VA Medical Center started implanting these sensors on patients, something done during endovascular aortic repair (EVAR) procedures (when a stent graft is inserted into the sac). The sensor is implanted in the aneurysm sac where it measures blood pressure information which is then collected by an external machine (aneurysms are weak areas that develop in blood vessels, especially the aorta).
Smaller sensors might be developed in the future, but right now physicians need to check whether there’s enough room for the sensor in the aneurysm during the pre-op CT scan, and sensors can’t be placed at a later time than the stent graft procedure. Since stent grafts tend to fail eventually and aneurysm size does not stay still, patients currently “subscribe” to CTs every 6-12 months for the rest of their life. The EndoSure system still requires visits to the hospital but will prevent the use of the injectable contrast agents necessary for CT scans.
Alternatively, the Endovascular Center at the Malmo University Hospital in Sweden successfully tested tip-pressure sensors mounted on guide wires last year, while vibrometry might offer even an even less intrusive technique. Abdominal aortic aneurysms (AAAs) ruptures alone cause more than 15,000 in the US each year (especially in males aged 55 years and more), so cheap, safe techniques to keep track of aneurysms could make a significant difference. Usually sac growth is monitored by CT or MRI, expensive and time-consuming procedures with side effects such as exposure to radiation.
Back to CardioMEMS, Crain’s Cleveland Business reports that the company just raised $16M from investors including Foundation Medical Partners, itself affiliated with the Cleveland Clinic Foundation. This raises potential conflicts of interest in this three-pronged relationship between a clinic where trials are run, a private company testing its products at the clinic, and a VC fund putting money from the later into the former. The Wall Street Journal recently wrote about (paid registration required) the somewhat similar relationship between the hospital and Atricure, another upstart company that manufactures a device to correct atrial fibrillation.
December 21, 2005 Related topics: Ethics & Scandals, Wireless, Product Approval & Certification, Corporate Financials, Cardiology