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By AMANDA PEDERSEN

CD&D Staff Writer

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.

Two companies — Bioheart (Sunrise, Florida) and St. Jude Medical (St. Paul, Minnesota) — reported the addition of systems performing such monitoring.

St. Jude received FDA approval for 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, Merlin.net Patient Care Network (PCN).

Bioheart secured worldwide non-exclusive distribution rights to the Bioheart 3370 heart failure monitor, an interactive device designed to improve available healthcare to patients outside hospitals who are suffering from heart failure. The device, made by a Danish firm, is cleared for marketing in both the U.S. and those countries recognizing the European CE mark.

Kathleen Janasz, a St. Jude spokeswoman, told Cardiovascular Devices & Drugs 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 Merlin.net 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 Merlin.net 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 Merlin.net 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 Merlin.net 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 Merlin.net 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.

The Bioheart device is made by RTX Healthcare (Noerresundby, Denmark). Bioheart said it planned to begin commercial distribution immediately.

"What you have is a patient population that really is ill and they do go home and they live their lives and things happen to the patient and oftentimes they go to the emergency room because it's an onset of something," Marty Schildhouse, a spokesman for Bioheart, told CD&D. "Daily monitoring allows for that constant awareness of any potential changes."

The compact Bioheart 3370 heart failure monitor engages patients through personalized daily interactions and questions, while collecting vital signs and transmitting the information directly into a database. It is available in both a wireless configuration and through hook-up to regular telephone lines, the company said. A remotely located medical professional regularly monitors the data for any abnormal readings that may signal a change in the patient's health status. These changes are reported back to the treating physician.

"Remote monitoring of heart failure patients forms a cornerstone of heart failure disease management, enhancing the opportunity to avoid episodes of worsening heart failure and emergency hospitalizations," said William Abraham, MD, a professor of internal medicine and director of the division of cardiovascular medicine at Ohio State University Medical Center (Columbus). "In the long run, our goal is to improve quality of life and keep patients out of the hospital."

Along with St. Jude Medical, Cybernet Medical (Ann Arbor, Michigan), Biotronik (Berlin, Germany), Medtronic (Minneapolis) and Boston Scientific (Natick, Massachusetts) also offer remote monitoring devices for heart patients, though most of these companies' devices are designed for patients with implanted cardiac devices, such as a pacemaker or defibrillator.

The Bioheart 3370 heart failure monitor collects data from a range of vital sign monitoring devices, a weight scale and a voice-activated heart failure status questionnaire, and provides for secure data transmission to an HTTP server on the Internet, the company noted.

"We are very excited about this tremendous opportunity to better serve the congestive heart failure patient population and their physicians," said Howard Leonhardt, Bioheart's CEO and chief technology officer. "This technology is highly synergistic to our work with MyoCell Therapy, an investigational cell therapy for the potential treatment of chronic heart damage, and marks the beginning of our ability to offer new intelligent devices that complement cell transplantation."

On average, Class III heart failure patients are hospitalized on an emergency basis six days of every six months, according to Bioheart. One of the goals of both MyoCell Therapy and the Bioheart 3370 monitor is to significantly reduce the number of emergency hospitalization days, as well as their associated costs, the company said.

"The Bioheart 3370 heart failure monitor is extremely simple and intuitive to use for elderly patients," said Bjarne Flou, CEO of RTX Healthcare. "We believe this partnership will deliver excellent value for patients and physicians."

The Bioheart 3370 monitor will be available through physician prescription.

"This product is going to be good for the patient, it's going to be good for the physician, and it also should be good for our healthcare system because it will help avoid visits to the emergency room," Schildhouse told CD&D.




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