Medtronic (Minneapolis) said the FDA has approved its CardioSight Service, a service for cardiologists monitoring heart failure patients to provide better care over time in order to adequately address problems when they arise.

The service works with several Medtronic cardiac re-synchronization therapy defibrillators or implantable cardioverter-defibrillators, the company said.

Valerie Lind, senior corporate communications manager for the Cardiac Rhythm Management business at Medtronic, told Diagnostics & Imaging Week, "Prior to this, the heart failure physicians haven't had access to information that's coming out of the defibrillator, and only the electrophysiologist .... gets a lot of the data and gets more comprehensive data than the heart failure physician."

Lind said that while the cardiologists and heart failure physicians don't implant medical devices, "there is data within the medical devices that could be advantageous to these heart failure clinicians that would allow them to understand what's going on with certain heart rhythm trends."

CardioSight also allows clinicians to identify some of the trends and some of the "unique features that Medtronic has within its own devices." For example, a new algorithm called the OptiVol trend that "identifies in advance if a heart failure patient is experiencing an increase in fluid in the lungs."

Lind said that fluid build-up in the chest is the reason behind most heart failure hospitalizations. Medtronic last December launched the InSync Sentry cardiac resynchronization therapy defibrillator system that it said was the world's first implantable medical therapy offering automatic fluid status monitoring in the thoracic cavity, which is the area encompassing the heart and lungs.

"Currently, it's very challenging for heart failure physicians to reliably, efficiently and regularly monitor their patients' heart rhythm activity or lung fluid levels," said Randall Starling, MD, head, section of heart failure and cardiac transplant medicine in the Department of Cardiovascular Medicine at the Cleveland Clinic Foundation. "Symptom-driven, immediate access to this data will aid the heart failure team" in caring for the patient.

CardioSight is a networked service. That service includes a monitor, which according to Lind looks something like an answering machine and acts like a "reader." That monitor is hooked up to a typical analog phone line.

According to Medtronic, "at the touch of a button, data can be transmitted from the implantable device via the CardioSight Reader. By holding the Reader's antenna (similar size and shape of a computer mouse) over the implantable device, they physician can quickly collect and download 90 days of the patient's cardiac rhythm trends and patients patterns without a device programmer."

The clinician's server then "automatically processes the data and creates a report and sends it via fax to the physician," within minutes, Lind said.

"The ability to diagnose and manage changes in heart rhythm patterns and heart failure symptoms is an important innovation we believe will improve standards of patient care," said Steve Mahle, president of Medtronic Cardiac Rhythm Management, in a statement. "Our devices can monitor and detect a wealth of clinical information, such as fluid buildup in the thoracic cavity with our new InSync Sentry system."

Mahle added, "By pairing these implantables with .... access solutions like CardioSight .... we can help more physicians identify changes in a patient's condition and modify prescribed therapies, which in turn may reduce hospitalizations."

Lind would not say how much the service will cost, but she said the entire network service is included in the cost. "It's definitely something new that's going to give them new insight into managing heart failure patients," she said. "I think at some point they will see it as a standard of care in treating their patients."

Medtronic reported in November that heart failure affects 5 million Americans and is the No. 1 cause of hospital admissions.

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