New Long-term Data Published in The Lancet Further Demonstrates Superiority of the CardioMEMS HF System over Standard of Care
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the publication of new, prospective data in The Lancet journal further supporting the long-term effectiveness of the CardioMEMS™ HF System at reducing heart failure (HF) hospitalizations for patients with New York Heart Association (NYHA) Class III HF.
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The analysis shows that after moving from standard HF therapy to management based on information from the CardioMEMS HF System, patients from the study’s control group had a 48 percent reduction in HF hospitalizations.
The CardioMEMS HF System was approved by the Food and Drug Administration (FDA) in May 2014 based on clinical data from the landmark CHAMPION clinical study, which had an average follow-up duration of 15 months. The new publication provides results over an extended time period (an average of 31 months) demonstrating the long-term benefit of hemodynamic monitoring in reducing heart failure hospitalization in these high risk patients.
All patients were implanted with the CardioMEMS sensor at the beginning of the study. The treatment group was monitored with the CardioMEMS HF System throughout the study with an average of 31 months of follow up. For the first 18 months, doctors treating patients in the control group were blind to the PA pressure readings and did not take readings into account when determining their treatment plan. Once physicians had access to the sensor readings for patients in the control group (open access period), they made patient management decisions based on pulmonary artery (PA) pressure data received from the CardioMEMS sensor rather than decisions based on signs and symptoms of worsening HF. This portion of the study represented a “real-world” experience since, based on the protocol, the study sponsor no longer provided communication with the study centers.
“This rigorous analysis showed a dramatic long-term impact for high-risk patients who were managed with the CardioMEMS HF System,” said Dr. Philip B. Adamson, medical director and vice president of medical affairs for St. Jude Medical. “During the first 18 months, the control group hospitalization rates remained high but once patient management using pressure data from the CardioMEMS HF system was introduced for the first time, we saw a hospitalization reduction of almost 50 percent, a clinically and highly statistically significant result.”
“Despite advances in medical care, a significant number of heart failure patients are readmitted to the hospital within a relatively short period of time and every hospitalization is very traumatic for those patients and their families,” said Dr. William Abraham, chief of cardiovascular medicine at The Ohio State University Wexner Medical Center. “The longitudinal analysis shows an important reduction in these admission rates when patients are monitored with the CardioMEMS HF System.”
Upon the treating physicians having access to the CardioMEMS PA pressure readings and managing the control group patients based on pressures, patients in the control group of the study experienced a statistically significant 48 percent reduction in HF hospitalizations. In addition, hospitalization rates continued to remain low in the treatment group during the open access period demonstrating the durability of the effect of home hemodynamic monitoring.
The CHAMPION study originally demonstrated a statistically and clinically significant 28 percent reduction in the rate of HF hospitalizations at six months, and a 37 percent reduction in HF hospitalizations during an average follow-up duration of 15 months. This new long-term, prospective data further supports the effectiveness of the CardioMEMS system at reducing HF hospitalizations by demonstrating the system can provide physicians the opportunity to proactively manage their HF patients.
The CardioMEMS HF System uses a miniature wireless monitoring sensor implanted in the PA to directly measure blood pressure and heart rate data. Patients can transmit this data from home to their health care providers, allowing providers to stabilize PA pressure by managing the patient’s medications more effectively.
The CardioMEMS HF System is the first and only FDA-approved HF monitor that, when used by physicians to monitor their HF patients, has been shown to significantly reduce HF hospital admissions and improve the quality of life in NYHA Class III patients.
About Heart Failure
More than five million Americans and about 26 million people worldwide suffer from heart failure, which occurs when the heart is unable to pump enough blood to the body. When this happens, blood pressure eventually rises, leading to shortness of breath, fatigue, swelling and other symptoms.
About St. Jude Medical’s Heart Failure Business
St. Jude Medical is pioneering heart failure disease management with innovative solutions like the CardioMEMS HF System, ground-breaking quadripolar technology and, in select European markets, the HeartMate 3 left ventricular assist system and our first-to-market MultiPoint pacing technology. St. Jude Medical collaborates with heart failure specialists, clinicians and advocacy partners to provide innovative, cost-effective solutions that help reduce hospitalizations and improve patient quality of life for heart failure patients around the world.
Information for patients to learn more about heart failure can be found at www.heartfailureanswers.com .
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 .
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K for the fiscal year ended January 3, 2015 and Quarterly Report on Form 10-Q for the fiscal quarter ended July 4, 2015. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
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