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St Jude Medical : New CHAMPION Data Show Significant Improvement in Survival Rates for Heart Failure Patients with Reduced Ejection Fraction

03/15/2015 | 10:22am EDT

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced a new data analysis from the CHAMPION trial showing that heart failure (HF) patients with reduced ejection fraction on optimal doses of guideline directed medical therapy (GDMT) managed by pulmonary artery (PA) pressure monitoring with the CardioMEMS HF System had a 57 percent reduction in mortality and a 43 percent reduction in HF hospitalizations compared with patients on GDMT managed by the standard of care (SOC). These data show a strong improvement for patients managed by optimal GDMT and the CardioMEMS HF System in both mortality and hospitalizations over currently defined best practices.

The CardioMEMS HF System uses a miniaturized, wireless monitoring sensor that is implanted in the pu ...

The CardioMEMS HF System uses a miniaturized, wireless monitoring sensor that is implanted in the pulmonary artery. (Photo: Business Wire)

The analysis looked at patients with HF and reduced ejection fraction (HFrEF) (when the heart muscle does not contract effectively and less oxygen-rich blood is pumped out to the body) over an average of 17 months who were on optimal GDMT and compared those managed by PA pressure monitoring with the CardioMEMS HF System to those managed by SOC. The CHAMPION trial retrospective analysis demonstrated that PA pressure monitoring, in addition to GDMT, significantly reduced HF hospitalizations and mortality in patients with reduced ejection fraction.

This new retrospective data analysis entitled “Pulmonary Artery Pressure Management in Heart Failure Patients with Reduced Ejection Fraction Significantly Reduces Heart Failure Hospitalizations and Mortality Above and Beyond Background Guide-Directed Medical Therapy” was presented today during the American College of Cardiology 64th Annual Scientific Sessions.

“For heart failure patients whose heart does not contract effectively, the risk for hospitalization and mortality is very high, even with appropriate evidence-based medical therapy. The findings from this analysis show us that use of the CardioMEMS HF System in addition to guideline directed medical therapy can significantly reduce hospital admissions for these heart failure patients and for the first time, we also see a significant improvement in survival,” said Dr. William Abraham, chief of cardiovascular medicine at The Ohio State University Wexner Medical Center and presenter of these data.

The CardioMEMS HF System uses a miniaturized, wireless monitoring sensor that is implanted in the pulmonary artery (the artery that delivers blood from the heart to the lungs) 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 and improve survival.

“The positive data based on pulmonary artery pressure management we see from the CHAMPION trial continue to demonstrate groundbreaking ways our physician partners manage their heart failure patients within the realities of the changing health care landscape,” said Dr. Mark D. Carlson, chief medical officer for St. Jude Medical. “St. Jude Medical is pioneering a new standard of care for heart failure management and the CardioMEMS HF System is the cornerstone of our heart failure portfolio.”

The CardioMEMS HF System is supported by strong clinical evidence, including data from the CHAMPION (“CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients”) trial published in The Lancet. The CHAMPION trial evaluated the overall safety and effectiveness of the CardioMEMS HF System for New York Heart Association (NYHA) Class III HF patients who had been hospitalized for HF in the previous 12 months. The CHAMPION trial demonstrated a 37 percent reduction in HF hospitalizations during an average follow-up duration of 15 months.

About Heart Failure
The Center for Disease Control and Prevention reports that more than 5 million Americans suffer from heart failure with 825,000 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.

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 and non-specific 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, may allow clinicians to stabilize PA pressures by proactively managing medications and other treatment options while also providing an early indication of worsening HF.

Learn more about the CardioMEMS HF System.

About St. Jude Medical’s Heart Failure Business
Approximately 26 million people worldwide suffer from heart failure. St. Jude Medical is pioneering heart failure disease management with innovative solutions like the CardioMEMS HF System, market-leading, ground-breaking quadripolar technology and, in select European markets, 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.

For more information about St. Jude Medical’s focus on heart failure, visit the St. Jude Medical Heart Failure Media Kit.

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.

Forward-Looking Statements
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. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

© Business Wire 2015
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