The FDA announced today that it had approved the CardioMEMS Champion HF System. The small implantable device provides daily pulmonary artery pressure measurements to guide physicians in their treatment of NYHA Class III heart failure patients who have been hospitalized for heart failure in the previous year. The system consists of three parts: a small permanent sensor implanted in the pulmonary artery, a catheter-based delivery system, and a system that acquires and processes PA pressure measurements from the implanted monitor and transfers the data to a secure database.
CardioMems had a rocky road to approval. Two separate times, in 2011 and in 2013, the FDA's Circulatory System Devices Panel agreed that the device was safe but that it had not been shown to be effective or that the benefits of the device outweighed the risks. Most of the discussion revolved around the pivotal CHAMPION trial which enrolled 550 heart failure patients. The FDA said today that it "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 said that it would require CardioMems to conduct "a thorough Post-Approval Study to continue to learn about the device’s performance when used outside the context of a clinical study."
CardioMEMS was founded by cardiologist Jay Yadav, who is also the company's CEO. The company is partly owned by St. Jude Medical, which said today that it would shortly complete the acquisition.
“Heart failure is one of the most common reasons for hospitalizations for people aged 65 and older,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, in an FDA press release. “The goal of this first-of-its-kind implantable wireless device with remote monitoring of pulmonary artery pressure is to reduce heart failure-related hospitalizations.”
There is widespread agreement that heart failure represent an enormous and growing burden on the health care system. CardioMems cites American Heart Association estimates that direct and indirect costs of heart failure in 2012 equalled $31 billion. However, it is unclear whether the device will be able to fulfill the high expectations suggested in this statement from a CardioMems representative:
Not only is this FDA approval going to impact the quality of life for patients, it will also save up to 40% in Medicare expenditures related to heart failure, which is the largest part of the Medicare budget.
