St Jude Medical wireless transmitter for implanted cardiac devices
gains FDA approval
2 August 2008
St Jude Medical, Inc. (NYSE:STJ) has received US FDA approval for its
wireless system for transmitting data from implanted cardiac devices.
The Merlin@home transmitter enables remote monitoring of patients'
implanted cardiac devices by medical staff.
The transmitter supports the St Jude Medical Current RF and Promote
RF family of devices and works in conjunction with the St Jude Medical
data management system, Merlin.net Patient Care Network (PCN), to
provide complete remote care service for patients and their physicians.
Until recently, patients with implanted cardiac devices were
typically required to visit doctors' offices several times per year to
have their device performance checked. With the advent of transmitters
capable of downloading and transmitting device data over telephone
lines, patients are now able to initiate and perform many of these
follow-ups in their own homes.
The Merlin@home transmitter's wireless technology gives patients the
additional comfort of having devices automatically checked. Since the
transmitter initiates the scheduled follow-up and uses RF wireless
telemetry to download data from the device, the entire follow-up
procedure is conducted without any direct patient involvement. The only
requirement is that each patient remains within range of the transmitter
while it reads his or her device. Patients also may initiate data
transmissions as instructed by their physicians.
The Merlin@home transmitter is transportable and can be set-up
wherever a standard phone line is available, typically by the bedside
for data transmission while the patient sleeps. Data downloaded by the
Merlin@home transmitter is sent to Merlin.net PCN, a secure,
Internet-based data management system, where it is stored for review by
the patient's physician.
"We have simplified remote follow-ups to the extent that they are now
something that can be performed seamlessly without interrupting the
patient's day. Patients simply set-up the Merlin@home transmitter; after
that, the system handles all aspects of patient follow up, including
daily monitoring," said Dr Eric Fain, president of the St Jude Medical
Cardiac Rhythm Management Division. "The simplicity of the system
reduces the chance of patients missing follow-up transmissions."
The Merlin@home transmitter also monitors cardiac devices outside of
regularly scheduled follow-ups. The system can perform daily checks to
monitor for alerts about device performance or about patient heart
rhythms that may have been detected by the implanted device. Merlin.net
PCN can be programmed to alert a physician directly — including an
on-call physician outside normal business hours — in the event that the
monitored data reveals an episode the physician needs to know about as
soon as possible.
"By directly alerting physicians, the Merlin@home transmitter and
Merlin.net PCN can help reduce risks associated with cardiac episodes
that physicians would want to know about right away," said Fain.
"Without this notification, these events might go undetected for
significant amounts of time. Direct notification is one more way to give
physicians more control over their patient's critical health care."
The Merlin@home transmitter will be available both in the US and
internationally later this year.