For many patients with an implanted heart device, frequent doctor visits to have device performance checked are a thing of the past. Now, a growing number of transmitters have been developed capable of downloading and sending device data over telephone or Internet channels so that many of these follow-ups can be done from the patient's home, importantly providing early notice of a problem and potentially quicker clinical intervention, if necessary.

Doing this automatically, without frequent or complex action required of the patient, is also seen as important for those with heart problems.

St. Jude Medical (St. Paul, Minnesota) yesterday reported FDA approval of its Merlin home transmitter, an RF wireless technology designed to remotely monitor patients' implantable cardiac devices (ICDs). The transmitter supports the St. Jude Current RF and Promote RF family of devices and works in conjunction with the St. Jude data management system, Patient Care Network (PCN).

Kathleen Janasz, a St. Jude spokeswoman, told Medical Device Daily that the patient would keep the Merlin@home transmitter — about the size of a clock radio — at home, typically by the bedside. Then, the transmitter remotely and wirelessly sends information to the data management network, the PCN, and is stored for the doctor to review.

What sets St. Jude's remote monitoring system apart from others on the market, she said, is that the data management network not only stores the information for the physician but also sends the data directly to the patient's electronic health record.

"We're the only company that has that system," she said.

Physicians also can program the system to provide an alert if the monitored data reveals an episode they need to know about immediately and take any needed action in reponse.

"By directly alerting physicians, the Merlin@home transmitter and PCN can help reduce risks associated with cardiac episodes that physicians would want to know about right away," said Eric Fain, MD, president of St. Jude's Cardiac Rhythm Management Division. "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."

St. Jude said the Merlin@home transmitter would be available in the U.S. early this fall and internationally in the fourth quarter.

The transmitter's wireless technology gives patients the additional comfort of having devices automatically checked, St. Jude said. 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 action needed. The patient only needs to stay within range of the transmitter in order for the implanted device to be read.

Patients also have the option to initiate data transmissions as instructed by their doctors.

Because the transmitter is transportable, Janasz said patients can take the device with them, for instance, on a vacation, so that they don't have to worry about missing a scheduled follow-up. All they need to set it up is a standard phone line, she said.

"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," Fain said. "The simplicity of the system reduces the chance of patients missing follow-up transmissions."

The system also offers flexibility, Janasz said. For example, if the patient is having symptoms that concern them, they can contact a doctor who can then provide instructions to initiate a data transmission outside of a programmed follow-up.

Another distinguishing feature of the PCN, Janasz said, is DirectCall Message, which uses an interactive voice recognition system to call patients to remind them of upcoming scheduled follow-ups, inform them if they have missed a follow-up, confirm that their transmitted data has been reviewed, or ask them to call their doctor's office for more information.

Remote patient monitoring of ICDs is important, Janasz said, because it helps get information to physicians quickly — in some cases, immediately — so they can get the patient into the office sooner if there is a problem.

St. Jude said the PCN supports all currently marketed Atlas and Epic implantable cardioverter defibrillators and cardiac resynchronization therapy devices in the U.S, as well as Current RF and Promote RF devices. The PCN system also 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, the company noted.

St. Jude has five major areas of focus: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation.