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News Patient Care Network receives US FDA approval

St Jude Medical : 19 April, 2007  (New Product)
US FDA approval has been granted to St Jude Medical's Patient Care Network, (PCN), an internet based central repository for patient device data. PCN enables physicians and clinicians to connect directly to their patients' stored device data at any time, from anywhere, that Internet access is available. PCN collects data from Implant procedures, remote transmissions and in-clinic follow-up sessions.

With immediate access to patient information through the secure 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 PCN from the comfort of their own home via the currently available Housecall Plus portable transmitter. PCN supports all currently marketed Atlas and Epic family implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy (CRT-D) device families in the USA.

In addition, PCN is a centralised 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 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 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 PCN, St Jude Medical offers a comprehensive patient care network that can be made available to any of our US 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'.
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