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US FDA approves software updates for Patient Care Network

St Jude Medical : 23 January, 2008  (New Product)
The US Food and Drug Administration (FDA) has approved software and firmware updates to St Jude Medical’s Patient Care Network (PCN).
The new PCN 2.5 will expand availability of the system nationwide and provide physicians with improved options for remotely monitoring their patients with the most commonly used St Jude Medical implantable cardiac devices.

The upgraded system includes enhancements to the Housecall Plus transmitter which patients use to convey data from their devices over phone lines to the central PCN data repository.

The new modifications offer improved ease of use for patients and physicians, a simple, one-step procedure for data transmission, expansion of services to include the entire USA, and the ability to accommodate patients with devices who travel out of the USA by allowing them to transmit data from overseas.

The US Veterans Health Administration (VA) has been using PCN since August 2007 (through its National ICD Surveillance Programme). Currently, 20 VA Medical Centers have enrolled to provide remote monitoring service to veterans with St Jude Medical defibrillators. Several special enhancements have been made in PCN to facilitate patient registration, transfer important device data to the VA National ICD Surveillance Programme web site, and electronically paste text-rich reports into the VA Computerised Patient Records System.

In addition, St Jude Medical is the first and only cardiac rhythm management company to satisfy the requirements established by the IHE (Integrating the Healthcare Enterprise), which promotes the adoption of standards for sharing healthcare information seamlessly across clinical settings. Compliance with IHE standards supports the compatibility of PCN with electronic health record (EHR) systems.

By designing in an open architecture, St Jude Medical allows clinics and physicians to utilise with their choice of EHR system. PCN already has successfully integrated into major EHR systems, including GEMMS, Lumedx and NextGen (through eMedApps), and is expanding its integration with other systems.

'The integration between GEMMS and PCN represents two market leaders moving beyond just interfacing data. These two, integrated products give users - in this case hospitals and clinics - a seamless clinical workflow,' said Rodger P Pinto, PhD, chief executive officer of GEMMS.

'Remote management of patients with implanted devices is critical to optimising the value of these therapies,' said Steve Compton, MD, chief of electrophysiology at Alaska Heart Institute. 'The ability to merge information captured by the device into the patient's electronic health record would ensure that we have a complete patient history from which to make clinical decisions. This can improve the quality of care and efficiency of patient management, especially for patients who are seen at more than one facility.' PCN is an internet-based central repository for patient device data that gives physicians immediate access to detailed information about the performance of the patient's device, allowing them to assess the patient and determine the level of care needed.

Patients with implantable cardiac devices use the Housecall Plus transmitter to send data from their devices directly to PCN from the comfort of their own homes. The system gives patients the freedom to send data, and physicians the ability to review it (during or outside of regular office hours), which may contribute to better early detection and care for patients with abnormal heart rhythms. PCN provides storage for important data that is captured in a patient's implantable cardiac device - from the Implant procedure, in-office follow-up visits and remote follow-up transmissions. Transmitted data includes reports of any episodes of irregular heart rhythms as well as a real time electrogram (EGM) that shows the patient's heartbeat at the time of transmission.

Data transmitted to the central repository is available to physicians via a secure log-in, and can also be integrated into existing patient electronic health records (EHRs) to ensure a comprehensive patient history is generated and accessible.

'The enhancements to our PCN system will enable better efficiency for both physicians and patients,' said Eric S Fain, president of the St Jude Medical Cardiac Rhythm Management Division. 'Seamless integration of patient data into electronic medical records is key to delivering and improving quality of care. We have developed PCN to be compatible with existing EHR systems, so physicians can use it with the clinic- and hospital-based systems they already have in use.'
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