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 Merlin.net Patient Care Network (PCN). Merlin.net 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, Merlin.net PCN can be fully integrated with
all standard electronic health record (EHR) systems in hospital or
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 Merlin.net PCN. Physicians can even use
Merlin.net 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 Merlin.net PCN and transmitted to the physician
via email, fax or SMS text. Merlin.net 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
A key exclusive feature of Merlin.net 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
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
Anticipating the rapid adoption of EHRs for storing patient data in
the healthcare industry, Merlin.net 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. Merlin.net PCN will be
launched in Europe this spring.
“The success of Merlin.net 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 Merlin.net 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. Merlin.net 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
Merlin.net 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’
Merlin.net 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 Merlin.net 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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