CardioExchange Archive

CardioExchange, an NEJM practice community for medical professionals dedicated to improving cardiac patient care, was active from 2009 to 2015. CardioExchange fostered discussion between clinicians from across the globe.

May 28th, 2014

FDA Approves Novel Implanted Sensor to Monitor Heart Failure

The FDA announced today that it has approved the CardioMEMS HF System. The small implantable device provides daily pulmonary artery (PA) 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.”

 

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