FDA approves CardioMEMS HF System to monitor Heart Failure patients - CardioMems Inc.
The FDA on 28 May 2014 approved the CardioMEMS HF System from CardioMems Inc. that measures the pulmonary artery (PA) pressures and heart rates of patients with New York Heart Association (NYHA) Class III Heart Failure who have been hospitalized for Heart Failure in the previous year. The device allows health care professionals to monitor the condition of their patients remotely.
The FDA believes that there is reasonable assurance that the device is safe and effective for Heart Failure management with the goal of reducing the rate of heart failure-related hospitalizations in certain patients. The FDA is requiring a thorough Post-Approval Study to continue to learn about the device�s performance when used outside the context of a clinical study.
In September 2010, St. Jude Medical invested $60 million for 19 percent ownership of CardioMEMS, with an exclusive option to purchase the remaining 81 percent of the company for $375 million. St. Jude Medical now intends to immediately exercise its exclusive option to acquire CardioMEMS, and expects to complete the acquisition in the second quarter of 2014.
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