St Jude Medical : CardioMEMS Data Shows Pulmonary Artery Pressure Monitoring Significantly Reduces Heart Failure Hospitalizations in Patients with Chronic Kidney Disease

Data presented at HFSA 2014 showed PA pressure monitoring did not adversely affect kidney function

ST. PAUL, Minn.--(BUSINESS WIRE)-- St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced a new data analysis from the CHAMPION clinical trial that evaluated outcomes in a subgroup of patients with renal dysfunction (kidney failure). The CHAMPION trial looked at the safety and effectiveness of the CardioMEMS™ HF System for patients with New York Heart Association (NYHA) Class III heart failure (HF) who had been hospitalized for HF in the previous 12 months.

The CardioMEMS system uses a miniaturized, wireless monitoring sensor that is implanted in the pulmonary artery (PA) during a minimally invasive procedure to directly measure PA pressure. Measuring PA pressure allows clinicians to proactively manage treatment for patients with worsening HF before visible symptoms, such as weight and blood pressure changes, occur. The system allows patients to transmit PA pressure data from their homes to their health care providers, who then manage appropriate medication changes to reduce the likelihood of hospitalization.

The subgroup data analysis of 297 patients followed for 18 months, presented during the Heart Failure Society of America (HFSA) 18th annual scientific meeting in Las Vegas, looked at the potential benefit for patients with NYHA Class III HF and chronic kidney disease (CKD) using the CardioMEMS system to measure PA pressure without adversely affecting renal function. These data show that management based on PA pressure reduced HF hospitalization in this patient population by 42 percent compared to the control group and did not adversely affect renal function.

"Patients who have heart failure often also suffer from chronic kidney disease and the worry is that medical therapies to avoid hospitalization will adversely affect renal function," said Dr. William Abraham, chief of cardiovascular medicine at The Ohio State University Wexner Medical Center and primary investigator for the CHAMPION trial. "Our goal in analyzing this group of patients was to demonstrate that monitoring pulmonary artery pressure with the CardioMEMS HF System can reduce hospitalizations without adversely affecting renal function and the data shows this to be true."

The Center for Disease Control and Prevention reports that more than 5 million Americans suffer from HF with 670,000 new cases diagnosed each year. Roughly 1.4 million patients in the U.S. have NYHA Class III HF, and historically these patients account for nearly half of all HF hospitalizations. According to the American Heart Association, the estimated direct and indirect cost of HF in the U.S. for 2012 was $31 billion and that number is expected to more than double by 2030.

"The CardioMEMS HF System is an innovative technology that helps physicians proactively manage their heart failure patients without adversely affecting the kidneys," said Dr. Mark D. Carlson, chief medical officer for St. Jude Medical. "This analysis and others demonstrate our commitment to investing in clinical research that provides physicians with data to improve patient care."

Heart failure occurs when the heart is unable to pump enough blood to meet the body's demands and blood pressure within the heart is elevated. Significant HF progression over a period of days is known as acute decompensation and leads to hospitalization. Increased PA pressures often precede indirect measures of worsening HF such as weight and blood pressure changes. The CardioMEMS HF System, approved by the U.S. Food and Drug Administration in May, 2014, allows clinicians to stabilize PA pressures by proactively managing medications and other treatment options while also providing an early indication of worsening HF.

About St. Jude Medical
St. Jude Medical is a global medical device manufacturer dedicated to transforming the treatment of some of the world's most expensive epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. Headquartered in St. Paul, Minn., St. Jude Medical has four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com or follow us on Twitter @SJM_Media.

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Source: St. Jude Medical, Inc.