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FDA approves first implantable wireless device with remote monitoring for HF patients
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The FDA today announced approval of the CardioMEMS HF System, which measures pulmonary artery pressure and heart rate in patients with NYHA class III HF who have been hospitalized for HF within the previous year. The device allows health care professionals to remotely monitor the condition of their patients, according to a press release.
The CardioMEMS HF System is usable by the patient in the home or any remote location. According to the FDA, this is the first permanently implantable wireless system intended to provide pulmonary artery pressure measurements, including systolic, diastolic and mean pulmonary artery pressures. The pressure data are reviewed by physicians, who can make decisions regarding the status of the patient and, if necessary, initiate changes to medical therapy, according to the 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,” Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, stated in the release.
The system consists of a battery-free implantable sensor/monitor implanted permanently in the pulmonary artery; a transvenous catheter delivery system designed to deploy the implantable sensor/monitor within the distal pulmonary artery; and the CardioMEMS Hospital and Patient Electronics System, which acquires and processes signals from the implantable sensor/monitor and transfers pulmonary artery pressure measurements to a secure database, according to the release.
The CardioMEMS HF System was approved based on data from its pivotal clinical study. Concerns about this study were discussed at a Dec. 8, 2011, meeting of the Circulatory System Devices Panel of the FDA’s Medical Devices Advisory Committee. The company provided additional follow-up data and analyses that were then discussed during an Oct. 9, 2013, meeting of the Circulatory System Devices Panel, according to the release.
The clinical study included 550 participants who had the device implanted and were randomly assigned to a control group or investigational group. Results showed a significant reduction in HF-related hospitalizations among participants whose doctors had access to pulmonary artery pressure data. Of the participants who had the device implanted, or in whom there was an implant attempt, 98.6% were free of device/system-related complications at 6 months. Among implanted devices, 100% were operational at 6 months, with no device explants or repeat implants during the study period, according to the release.
The FDA will require a post-approval study to determine the performance of the device outside the context of a clinical study.
“The CardioMEMS [HF] system creates a new paradigm for proactive management of heart failure and will greatly benefit patients and their families,” Jay S. Yadav, MD, CardioMEMS founder and CEO, stated in a company press release.