|By Business Wire||
|May 8, 2014 05:31 PM EDT||
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, announced that data presented during a Late Breaking Clinical Trial Session during Heart Rhythm 2014, the Heart Rhythm Society’s Annual Scientific Sessions, found an association between adherence to remote monitoring with the St. Jude Medical Merlin™ Remote Monitoring System and a reduction in patient mortality. Results from more than 260,000 patients implanted with either pacemakers or defibrillators demonstrated that patients with high adherence to remote monitoring had more than twice (2.4x) the probability of survival than that of patients without remote monitoring.
The prospective, observational study of U.S. patients also found that the greater adherence to remote monitoring, the better the patient fared. Patients with high adherence to remote monitoring – measured as weekly transmission of patient data from the Merlin@Home System to the Merlin.net™ Patient Care Network at least 75 percent of the time – overall had a 58 percent reduced likelihood of mortality than patients not using remote monitoring and a 35 percent reduced likelihood of mortality than patients with low remote monitoring. Though there was geographic variability, socioeconomic factors were not associated with remote monitoring use.
“This study is the first of its kind to find increased survival when remote monitoring is utilized in pacemaker patients,” said Dr. Suneet Mittal, director of EP at the Valley Hospital Health System of NY and NJ. “Furthermore, our data suggest that, irrespective of whether a patient has a pacemaker or defibrillator, higher use of remote monitoring is associated with better survival. Although these associations require further investigation, these important observations should have significant implications for individual patient care and best-practice guidelines.”
All St. Jude Medical FDA-approved implantable cardiac devices capable of radiofrequency (RF) remote monitoring were included in the study, which had a cohort of 262,564. This is the largest study to-date of remote monitoring pacemaker patients, and one of the largest for remote monitoring overall.
“Patients with implanted cardiac devices are typically required to visit doctors’ offices several times per year to have their device performance checked, which for many can be impractical. This new research demonstrates that the Merlin Patient Care System not only adds convenience for physicians and patients, it helps patients to live longer,” said Dr. Mark D. Carlson, chief medical officer for St. Jude Medical.
About the Merlin Patient Care System
The Merlin Patient Care System supports St. Jude Medical cardiac resynchronization therapy (CRT) devices, implantable cardioverter defibrillators (ICDs) and pacemakers. The system was designed to help physicians efficiently analyze therapeutic and diagnostic data.
Once a supported device is implanted, the Merlin.net Patient Care Network gathers and stores data from the implant procedure, in-clinic follow-up visits and from remote device transmissions sent from a patient’s home. Remote transmissions are sent via the Merlin@home™ Transmitter, a system that allows patient data from an implanted cardiac device to be wirelessly downloaded and securely transmitted for clinician review. Patients using a Merlin@home transmitter are able to transmit data to their physician via a broadband Internet connection, cellular network and standard phone line.
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 December 28, 2013 and Quarterly Report on Form 10-Q for the fiscal quarter ended March 29, 2014. 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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