Healthcare Industry News: neuromodulation
News Release - April 18, 2007
St. Jude Medical Announces FDA Approval of Internet-Based Data Management System For Implantable Cardiac DevicesMerlin(TM).net Patient Care Network is First Cardiac Rhythm Management Remote Monitoring System to Comply with Industry Standards for Patient Electronic Health Records
ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced U.S. Food and Drug Administration (FDA) approval of the Merlin.net Patient Care Network, (PCN), an Internet-based central repository for patient device data that enables physicians and clinicians to connect directly to their patients' stored device data at any time, from anywhere, that Internet access is available.
Merlin.net PCN collects data from implant procedures, remote transmissions and in-clinic follow-up sessions. With immediate access to patient information through the secure Merlin.net PCN website, physicians can monitor and assess patient device data and determine the level of care needed remotely. Patients can send data directly to physicians using Merlin.net PCN from the comfort of their own home via the currently available Housecall Plus(TM) portable transmitter. Merlin.net PCN supports all currently marketed AtlasŪ and EpicŪ family implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT-D) device families in the United States.
In addition, Merlin.net PCN is a centralized storage system that allows data to be sent directly to a clinic's or hospital's electronic health records (EHR) system. The ability to transfer device data from Merlin.net PCN to an EHR system, where a patient's comprehensive medical history is stored, may enhance patient safety by providing physicians with all pertinent medical information in one location to aid their decision making.
The Merlin.net system adheres to the patient privacy standards and requirements for the electronic transmission of health information, as set forth by the Health Insurance Portability and Accountability Act of 1996 (HIPAA). At the clinic, only assigned users have access to password-protected patient data, which is encrypted during transmission and backing-up of data.
St. Jude Medical is the first cardiac rhythm management company to complete a testing process established by the IHE (Integrating the Healthcare Enterprise), an initiative promoting the adoption of standards that enable healthcare information to be shared seamlessly across clinical settings.
"With Merlin.net PCN, St. Jude Medical offers a comprehensive patient care network that can be made available to any of our U.S.-based Atlas and Epic family ICD and CRT-D patients and their physicians," said Michael J. Coyle, president of St. Jude Medical's Cardiac Rhythm Management Division. "Our adherence to industry connectivity standards for remote monitoring and data sharing provides an efficient environment that will advance the management of patient care both in and out of the hospital setting."
IHE (www.ihe.net) is a global initiative, now in its ninth year, that creates the framework for exchanging health information seamlessly - from application to application, system to system, and setting to setting - across healthcare enterprises. IHE brings together clinicians and other healthcare information technology stakeholders to implement standards for communicating patient information efficiently. Because of its proven success for collaboration, testing, demonstration and real world implementation of interoperable solutions, IHE is in a unique position to accelerate deployment of interoperable electronic health records systems.
About St. Jude Medical
St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The Company has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 11,000 people worldwide. For more information, please visit www.sjm.com.
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 Company's Annual Report on Form 10-K filed on February 28, 2007 (see Item 1A on pages 13-20, and page 20 of Exhibit 13 to the Company's Form 10-K). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
Source: St. Jude Medical
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