St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced a new analysis published in the Journal of the American College of Cardiology: Heart Failure shows pulmonary artery (PA) pressure monitoring with the St. Jude Medical™ CardioMEMS™ HF System can improve medical management and prevent hospitalizations of heart failure patients as compared to the traditional standard of care (weight and blood pressure tracking). The study supports the use of PA pressure monitoring to help clinicians proactively identify the early onset of worsening heart failure and to adjust therapeutic interventions in order to decrease the risk that patients will be hospitalized for congestive heart failure.

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The CardioMEMS HF System features a miniaturized, wireless monitoring sensor. (Photo: Business Wire)

The CardioMEMS HF System features a miniaturized, wireless monitoring sensor. (Photo: Business Wire)

In patients suffering from chronic heart failure, the heart cannot adequately pump blood to meet the body's demands. As heart failure worsens, increased pressures can develop in the heart and pulmonary arteries, which previous research has shown to adversely affect patients' health and increase the risk of hospitalization.

A new analysis of data from the CHAMPION study found that actively monitoring patients with the CardioMEMS HF System was more effective in reducing heart failure hospitalizations than conventional medical management.
  • Improved medication management: The analysis showed using the CardioMEMS HF System led to personalized heart failure medication management including an opportunity to provide the best and most effective dosing of diuretic compared to the current methods used to manage patients with heart failure. (Diuretics are typically used to stimulate kidney function and reduce swelling caused by heart failure.)
  • Reduced heart failure hospitalizations: In turn, the analysis showed that these proactive adjustments to medications based on PA pressure management with the CardioMEMS HF System led to a 37 percent reduction in hospitalizations versus patients managed based on the current standard of care.
  • Repeatable process to reduce hospitalizations: Further, the analysis validates guidance outlined in the CHAMPION protocol and reported in the manuscript for remote medication adjustments, which were directly associated with a reduction in heart failure hospitalizations and improvement in overall patient outcomes.

"This latest analysis of the CHAMPION data shows that individualizing medication dosing in heart failure patients using information from the CardioMEMS device is more effective in keeping them out of the hospital and can be accomplished with remote monitoring in the patient's home environment," said Dr. Philip B. Adamson, medical director and vice president of medical affairs for St. Jude Medical.

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 trial 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.

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, our first-to-market MultiPoint Pacing technology and, in select European markets, the HeartMate 3 left ventricular assist system.

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 or the St. Jude Medical PULSE Blog.

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 leading global medical device manufacturer and is dedicated to transforming the treatment of some of the world's most expensive epidemic diseases. The company has five major areas of focus that include heart failure, atrial fibrillation, neuromodulation, traditional cardiac rhythm management, and cardiovascular. 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, reimbursement strategies, 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 2, 2016. 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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