Medtronic launches implantable cardiac devices with wireless telemetry
in Europe
19 June 2006 Nice, France. Medtronic, Inc., (NYSE:MDT) has announced
European approval and market availability of its Concerto and Virtuoso line
of implantable cardiac defibrillators. These are Medtronic's first cardiac
rhythm disease management devices with wireless telemetry, enabling
communication remotely between the implanted device and programmers in a
clinician's office and at implant, or between the device and a patient home
monitor.
The newly available products include the Concerto cardiac
resynchronisation therapy-defibrillator (CRT-D) and Virtuoso single- and
dual-chamber implantable cardioverter-defibrillators (ICDs). They were
launched at Cardiostim 2006, the 15th World Congress in Cardiac
Electrophysiology and Cardiac Techniques in Nice.
The devices allow heart patients to automatically receive visual
notification on a home monitor called the PatientLook Indicator when their
device detects an alert, such as atrial fibrillation, thoracic fluid
accumulation, or a device performance issue. If the PatientLook Indicator
notes an alert condition, patients are instructed to call their physician
with this important health status information. In addition, patients may
also manually initiate a self-check to view the status of their condition,
and get visual notification of their alert status. "With the advent of
wireless communication between implantable cardiac devices and programmers,
as well as home monitors, we see new opportunities for more convenient and
more effective implants, device management and patient care," said Professor
and Dr. of Medicine Christina Unterberg-Buchwald of University Hospital
Gottingen, Germany.
"These devices have the potential to improve patients' quality of life and
the care they receive, because of the availability of the alert
notifications," added Dr. Dieter Zenker, University Hospital Gottingen,
Germany. Professor Unterberg-Buchwald and Dr. Zenker worked together on the
earlier Concerto AT trial. The Virtuoso ICDs and Concerto CRT-D help track
and manage heart failure symptoms. They also will deliver a shock to
terminate a dangerously abnormal heart rhythm. The Concerto CRT-D device
also sends tiny electrical impulses to the heart muscle to resynchronise the
contractions of the heart's lower chambers, helping the heart pump blood
throughout the body more efficiently. These devices were recently approved
by the United States Food and Drug Administration. Other features of the
system include:
- Conexus Wireless Telemetry with SmartRadio Technology: utilising the
Medical Implant Communication Service (MICS) radio frequency band,
402-405 MHz, Medtronic Conexus Telemetry enables reliable communication
between the patient's implanted device and home monitor or clinician
programmer at a range of two to five meters. The MICS band is a
frequency designated by global telecommunications regulatory authorities
for implantable medical device communication. It protects wireless
medical devices from interference caused by cellular or cordless phones
and other common electronic devices, providing a level of protection
that cannot be offered by systems that use other frequencies.
- OptiVol Fluid Status Monitoring: OptiVol measures changes in
impedance in the thoracic cavity, the chest area encompassing the lungs
and heart. Using very low electrical pulses that travel across the
thoracic cavity, the system can measure the level of resistance to the
electrical pulses, which indicates the level of fluid in the thorax.
Since normal fluid levels may vary from patient to patient and fluid
accumulation can be either slow or rapid, OptiVol's ability to measure
fluid status trends over time can provide important patient data to use
in conjunction with ongoing monitoring of other patient symptoms.
- Left Ventricular Capture Management: LVCM, available on the Concerto
CRT-D, is intended to automatically sense and adjust impulses for
stimulation of the heart's lower left chamber (ventricle) and ensure
cardiac resynchronisation therapy.
- ATP During Charging: Automatically uses pacing pulses to painlessly
stop fast, dangerous heartbeats, while concurrently preparing to deliver
a shock if needed, with no delay.
- Managed Ventricular Pacing: MVP Mode, available on the Virtuoso DR
(dual chamber) ICD, promotes intrinsic conduction and reduces right
ventricular pacing by 99% (median), potentially reducing the risk of
heart failure hospitalisations and atrial fibrillation.
"We're raising the level of innovation with the introduction of
wireless telemetry, combined with OptiVol Fluid Status Monitoring and
the most advanced therapies and diagnostics," said Steve Mahle,
president of the Cardiac Rhythm Disease Management business at
Medtronic. To top
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