St Jude Medical gains EU approval for remote care system for implantable cardiac devices

7 May 2009

St Jude Medical, Inc. (NYSE:STJ) has received European CE Mark approval of its Patient Care Network (PCN). PCN is a secure, Internet-based remote care system that gathers and stores data from the implant procedure, a clinic follow-up visit or from remote follow-up transmissions of patients with implanted cardiac devices.

The system includes a range of features designed to improve clinic efficiency and to enhance patient care by giving physicians better and more immediate access to information. With its open architecture and standards-based interface, PCN can be fully integrated with all standard electronic health record (EHR) systems in hospital or clinic settings.

Until recently, the only way for physicians to check on their patients’ devices was for a patient to come to their clinic in person. Now, information from a patient’s implanted device can be transmitted remotely from the comfort of a patient’s home. St Jude Medical patients with compatible devices can use the Merlin@home transmitter to send data directly from their devices to PCN. Physicians can even use PCN to schedule the remote follow-up to take place at night, while the patient is sleeping.

Remote monitoring provides daily checks on the patient’s device. If the check reveals an event that may require timely intervention, an alert will be posted on PCN and transmitted to the physician via email, fax or SMS text. PCN offers a set of flexible tools that allow the physician to choose when, where and how alerts are communicated during off-clinic hours, including the transfer of alerts to after hours support services.

Alert-triggering events are not restricted to device performance, but also include clinical episodes such as atrial tachycardia (AT), atrial fibrillation (AF), and ST segment change notifications for remote disease management.

A key exclusive feature of PCN is DirectCall Message, an automated calling system that the clinic staff can use to call patients with up to four pre-recorded messages in any of approximately 20 languages.

The system can be used to remind patients of an up-coming scheduled follow-up, notify them that they have missed a scheduled follow-up, inform them that their remote transmission has been received and everything looks normal, or ask them to call the clinic to discuss the results of the follow-up.

These are all routine calls that are regularly made by clinic staff. With this new technology, clinics can quickly and efficiently provide information to patients regarding their device status for enhanced assurance.

Anticipating the rapid adoption of EHRs for storing patient data in the healthcare industry, PCN was built on an open architecture platform, which allows for the seamless transfer of data to major EHR suppliers’ systems. Other efficiency features include a unique online scheduling tool that allows clinics to create schedules that are automatically adjusted for clinic holidays, and data management options such as batch reviewing, printing and storing multiple patient files.

The system has been adopted widely into clinics and hospitals in the United States since it was released in 2008. PCN will be launched in Europe this spring.

“The success of PCN in the United States has been built through a combination of tools that offer physicians more control over their patients’ device monitoring and features that help their clinics run more efficiently,” said Eric S Fain, MD, president of the St Jude Medical Cardiac Rhythm Management Division. "We are delighted to now offer these benefits to our customers and to patients in Europe.”

About Patient Care Network (PCN)

Implantable cardiac devices are designed to capture and record large volumes of data on device performance and patient heart rhythms vital to patient care. PCN is a secure information network that stores this information for a minimum of seven years, allows data to be viewed over the internet by select users, and sends data directly to a clinic's or a hospital's electronic health records (EHR) system as part of a patient’s comprehensive personal health record.

With rapid access to patient information through the secure PCN Web site, physicians can remotely monitor and assess patient device data to determine their required level of care. Alert notification delivery times can be customized to fit clinic hours, including potential after-hours notifications based on the clinics’ preferences. PCN supports the Current RF implantable cardioverter defibrillators (ICDs) and Promote RF cardiac resynchronization therapy defibrillator (CRT-D) family of devices and all currently marketed Atlas ICD and Epic CRT-D device families. The PCN system adheres to 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).

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