Atlanta, Georgia-based health device maker CardioMEMS received FDA clearance for its CardioMEMS HF System, which monitors pulmonary artery pressure, but for patients who have experienced New York Heart Association (NYHA) Class III heart failure and have been hospitalized for heart failure in the previous year.
After the small sensor is implanted into the pulmonary artery, which is a blood vessel near the heart, users can take readings from a bedside monitor and send them to a physician. They send this information through an antennae embedded in a pillow. Users must lie face up on the pillow to send the data. This system can also help physicians keep track of reactions to medications and dosages and make changes accordingly.
“Heart failure is one of the most common reasons for hospitalizations for people aged 65 and older,” Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health said in a statement. “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.”
This device was cleared two years after the FDA rejected the device when CardioMEMS went through the process for the first time. Although at the time the FDA’s Circulatory Systems Devices Panel voted 9-1 that the implantable monitor was safe, the committee ruled 7-3 that there was no reasonable assurance of the effectiveness of the device and voted 6-4 that risks outweighed potential benefits.
In October 2013, CardioMEMS provided additional follow-up data and analysis from a new study to address the concerns from the initial meeting.
This second study of 550 patients showed an even larger reduction in heart failure-related hospitalizations for the patients who were sharing data with their physicians. Just about 98 percent of patients with the device implanted were free from device-related complications after six months. Of the devices implanted, all of them were operational after 6 months. None of the devices had been replaced in that time.
In 2010, St. Jude invested $60 million in CardioMEMS for 19 percent of the company. They also had an option to purchase the remaining 81 percent of the company for $375 million. With this new FDA clearance, St. Jude Medical said that it now intends to exercise its option to acquire CardioMEMS, and plans on completing the acquisition in the second quarter of 2014.