FDA Approves the CardioMEMS HF System for Remote Monitoring of Pulmonary Artery Pressure

May 28, 2014—The US Food and Drug Administration (FDA) announced that it has approved the CardioMEMS HF system (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.

In related news, St. Jude Medical announced that it intends to immediately exercise its exclusive option to acquire CardioMEMS and expects to complete the acquisition in the second quarter of 2014. St. Jude Medical will begin a strategic launch of the CardioMEMS system in the United States. In September 2010, St. Jude Medical invested $60 million for 19% ownership of CardioMEMS with an exclusive option to purchase the remaining 81% of the company for $375 million.

According to the FDA, the CardioMEMS HF system is used by the patient in the home or other remote location. This is the first permanently implantable wireless system intended to provide PA pressure measurements, including systolic, diastolic, and mean PA pressures. The PA pressure data are reviewed by physicians who can make decisions regarding the status of the patient and, if necessary, initiate changes in medical therapy, with the goal of reducing hospitalization due to heart failure.

The FDA advised that the CardioMEMS HF system is composed of three parts: a battery-free implantable sensor/monitor that is implanted permanently in the PA; a delivery system that is a transvenous catheter designed to deploy the implantable sensor within the distal PA; and the CardioMEMS hospital and patient electronics systems, in which the electronics system acquires and processes signals from the implantable sensor/monitor and transfers PA pressure measurements to a secure database.

In the FDA press release, Christy Foreman, Director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, commented, “Heart failure is one of the most common reasons for hospitalizations for people aged 65 years and older. The goal of this first-of-its-kind implantable wireless device with remote monitoring of PA pressure is to reduce heart failure-related hospitalizations.”

To support the approval, CardioMEMS submitted data from its CHAMPION pivotal clinical study. In February 2011, CardioMEMS announced the publication of the CHAMPION results by William T. Abraham, MD, et al in The Lancet (2011;377:658–666).

The FDA noted that concerns about the clinical study were discussed at the December 8, 2011, meeting of the Circulatory System Devices Panel of FDA’s Medical Devices Advisory Committee. The company provided additional follow-up data and analyses that were discussed at the October 9, 2013, meeting of the Circulatory System Devices Panel to address these concerns.

As summarized by the FDA, the CHAMPION clinical study randomized 550 patients to the control group or investigational group. The results showed a clinically and statistically significant reduction in heart failure-related hospitalizations for the participants whose doctors had access to PA pressure data. Of the participants who had the device implanted (or in whom there was an attempt to implant the device), 98.6% were free from device/system-related complications at 6 months. Of the devices implanted, 100% were operational at 6 months, and there were no device explantations or repeat implantations during this time period.

The FDA stated that the agency 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 postapproval study to continue to learn about the device’s performance when used outside the context of a clinical study.

Headquartered in Atlanta, Georgia, CardioMEMS was founded and is led by interventional cardiologist and Chief Executive Officer Jay Yadav, MD. In a press release from the company, Dr. Yadav commented, “We want to thank the patients and clinicians who worked with us to prove the benefit of the CardioMEMS HF system. We also want to thank FDA for making this technology available to heart failure patients in the United States. The CardioMEMS system creates a new paradigm for proactive management of heart failure and will greatly benefit patients and their families.”

In the press release, the company noted that the CardioMEMS HF management system has been proven to significantly reduce heart failure-related hospitalizations and improve the quality of life for the more than 6 million Americans with heart failure. The CardioMEMS wireless sensing and communication technology is designed to improve the management of severe chronic cardiovascular diseases such as heart failure, aneurysms, and hypertension. The sensors can be permanently implanted into the heart and blood vessels due to their small size, durability, and lack of wires and batteries.

CardioMEMS stated that this technology was developed with the belief that frequent, on-demand, real-time monitoring of vital information enables proactive patient management leading to fewer hospitalizations, improved patient quality of life, and more efficient and cost-effective health care.

St. Jude Medical group president Eric S. Fain, MD, commented in a company press release, “The CardioMEMS HF system will not only improve the lives of patients, but will also reduce the economic burden of this epidemic disease, and we are delighted to have CardioMEMS become a part of St. Jude Medical.” Referring to the CHAMPION results, Dr. Fain added, “Unlike telemonitoring of weight and blood pressure, transthoracic impedance, or intensified clinic follow-up, the CardioMEMS HF system is the only FDA-approved monitoring technology that has demonstrated the ability to significantly reduce heart failure hospitalizations in a large-scale clinical trial. This one-time implant, delivered using a catheter-based procedure, will allow physicians to proactively manage pressures to an individually tailored target rather than reacting to symptoms once a patient’s heart failure has worsened.”

St. Jude Medical also advised that the US Centers for Medicare & Medicaid Services have implemented initiatives to promote better outcomes, patient safety, and effective care by requiring hospitals to collect data on various quality metrics, most notably heart failure readmission rates. The company noted that these data are publicly available with the purpose of increasing hospitals’ accountability for quality outcomes in order to preserve reimbursement for patient care. The CHAMPION trial demonstrates that the CardioMEMS HF System provides both clinical and economic benefits for the health care community, stated St. Jude Medical.

“I believe this strategy has the potential over time to change heart failure. Not just to lighten the burdens every day or to decrease the number of hospitalizations, but to decrease the grim progression of the disease,” commented Lynne Warner Stevenson, MD, in the St. Jude Medical press release. Dr. Stevenson is director of the Heart Failure Program at Brigham and Women’s Hospital in Boston, Massachusetts.