Diagnostics & Imaging Week

The FDA has approved what Boston Scientific (Natick, Massachusetts) calls the first remote monitoring system to provide clinicians with direct device data integration capability into the Centricity Electronic Medical Record (EMR) from GE Healthcare (Waukesha, Wisconsin).

Boston Scientific and GE Healthcare recently reported the first integration of remote device information direct to EMRs. The FDA approved the Latitude Patient Management software — a remote monitoring system for cardiac device patients — with integration capabilities into the Centricity EMR.

The system works with patients implanted with a Contak Renewal 3RF device, a combination pacemaker and defibrillator with radio frequency, Dave Knutson, a Boston Scientific spokesman, told Diagnostics & Imaging Week. While the patient is sleeping at night another device — the communicator, which Knutson said resembles a Caller ID box with a short antenna — sits near the bed and collects vital information from the patient's implanted device and sends it to the doctor's office through the phone line to a secure web site. In the morning, a doctor or nurse can access the web site with a password to check the patient's device and vital signs.

"For the patient it offers peace of mind and daily assurance that their device is working every single day," Knutson told D&IW in a phone interview Monday from the American Heart Association (AHA; Dallas) conference in Chicago.

Boston Scientific is giving demonstrations of its Latitude Patient Management System at AHA this week, but Knutson said the company will not be giving any formal presentations or releasing any clinical results yet. He anticipates that next year's AHA conference will likely include a presentation on the device.

Knutson said the system also reduces unscheduled doctor's visits because if a patient thinks something might be wrong he or she can call the doctor who can "simply go online and say, 'you know what, your device is working perfectly — why don't you wait and come in tomorrow for your scheduled visit.'"

Another feature of the system, Knutson said, is the device's ability to send the doctor yellow alerts and red alerts. Yellow might tell the doctor, for example, that the device's battery is getting low and red normally indicates something is wrong with the device or the patient.

Guidant (Indianapolis), owned by Boston Scientific, received FDA approval for the Latitude Communicator and secure data storage system in September 2005.

Being able to use the system with GE's Centricity EMR provides another benefit for the physician, Knutson said.

"Now our doctor who logs on not only gets a device status and the patient's status, but can get the patient's whole medical history," Knutson said.

Vishal Wanchoo, president/CEO of GE Healthcare Integrated IT Solutions, called the GE/Boston Scientific collaboration a "major stepping stone" in GE's effort to provide a comprehensive patient record across the continuum of care.

"The ability to collect patient data remotely using Latitude technology and integrating that data, along with historical medical information, within the patient's electronic medical record should empower physicians to make more accurate decisions at the point of care," Wanchoo said.

The Latitude system could cost up to $33,000, Knutson said, which includes the implanted device, the communicator, the hardware the physician needs to be able to access the information, and 24-hour monitoring to alert the doctor if anything appears to be wrong.

Because the device is portable, Knutson said it also is convenient for the patient to use at home or while traveling and that its operation doesn't depend on patient compliance.

"This asks the patient to do nothing but go to bed at night," Knutson said. "The compliance is there."

The patient is required to be within 8 feet of the communicator for it to work, the company said. It uses the same phone line as the patient's phone, and if the patient is on the phone when the communicator is scheduled to send data, the device will wait until the patient is off the phone to do its job. The doctor could schedule information to be collected as often as every day, or as seldom as once every few months.

According to Boston Scientific, the Latitude system will eventually be available for other types of heart failure devices too, such as pacemakers and implantable cardioverter defibrillators. The company's medical devices are used in a broad range of interventional medical specialties.

Ric Jackson, marketing development manager for GE Healthcare's Integrated IT Solutions, said the integration between the Latitude system and the Centricity EMR adds value to the system because it allows physicians to pull up a patient's entire medical history, including illnesses and treatments, while reviewing other data collected by the Latitude's communicator.

"A cardiovascular patient is a cardio patient for life," Jackson told D&IW. "It's a major milestone in the ability to provide information in the longitudinal format."

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