St. Jude Medical’s CardioMEMS HF System Shows Positive Clinical Data

St. Paul, Minn.-based St. Jude Medical Inc. has new data from Northwell Health highlighting the center’s experience with the CardioMEMS HF system. The study demonstrated that monitoring pulmonary artery pressure with the CardioMEMS technology leads to significant improvements in quality of life (as measured by the Kansas City Cardiomyopathy Questionnaire [KCCQ]) and ability to exercise (using the six minute walk [6MW] test standard) in patients with chronic heart failure. These data were presented at the American College of Cardiology 65th Annual Scientific Session.

“The data confirms that patients who are monitored using the CardioMEMS HF system are seeing significant improvements in the quality of their lives, including an increase in exercise capacity,” said Dr. Rita Jermyn, director, Congestive Heart Failure Program at North Shore University Hospital, Manhasset, New York, part of Northwell Health.

The analysis evaluated 66 patients with New York Heart Association (NYHA) Class III heart failure; 34 underwent implant of the CardioMEMS device and 32 patients remained on medical management alone. Quality of life (QoL) was assessed based on the KCCQ that measures QoL items such as physical and social function, symptoms and self-efficacy. A 6MW test was conducted to evaluate exercise capacity for each patient. The study found management with the CardioMEMS device led to a: decrease of nearly seven percent in body weight; three-fold increase in quality of life scoring; increase of 38 percent in the distance patients were able to walk within the 6MW test.

“We are excited to see independent data from centers implanting the CardioMEMS device and are very pleased to see such great results from Northwell Health,” said Dr. Philip B. Adamson, medical director and vice president of medical affairs for St. Jude Medical. “The study data confirm benefits originally observed in our landmark Champion study, which show patients who are monitored with the CardioMEMS HF system have a reduction in hospitalizations and an improvement in their quality of life.”

The CardioMEMS HF system uses a miniature wireless monitoring sensor implanted in the pulmonary artery to directly measure pulmonary artery pressure. Patients can transmit these data from home to their health care providers, allowing providers to stabilize pressure by managing the patient’s medications more effectively.

The CardioMEMS HF system is the first and only FDA-approved heart failure monitor that, when used by physicians, has been shown to significantly reduce heart failure hospital admissions and improve the quality of life in New York Heart Association (NYHA) Class III patients. Long-term, prospective data published in The Lancet supports the effectiveness of the CardioMEMS HF system at reducing heart failure hospitalizations by demonstrating the system can provide physicians the opportunity to proactively manage their heart failure patients.

The Champion study originally demonstrated a statistically and clinically significant 28 percent reduction in the rate of heart failure hospitalizations at six months, and a 37 percent reduction in heart failure hospitalizations during an average follow-up duration of 15 months.