Medtronic initiates 50-site study of defibrillator with wireless
9 February 2006
Minneapolis, USA. Medtronic, Inc., (NYSE:MDT) has begun the first
implants in a trial of its Concerto cardiac resynchronization therapy
defibrillator (CRT-D) with atrial therapies (AT).
The clinical study is a prospective, non-randomized, multi-centre, global
clinical trial involving up to 425 patients at approximately 50 sites in
Europe, the United States and Japan. The purpose of the study is to assess
the safety and efficacy of atrial defibrillation therapy in patients with a
current indication for CRT and ICD.
CRT devices send tiny electrical impulses to the heart muscle to
resynchronize the contractions of the heart's lower chambers, helping the
heart pump blood throughout the body more efficiently and reducing patients'
heart failure symptoms. CRT-D devices also can deliver a shock to terminate
a dangerously abnormal heart rhythm.
The Concerto/Virtuoso line of implantable devices, which includes the
Concerto CRT-D and Virtuoso implantable cardioverter-defibrillator (ICD),
will be Medtronic's first cardiac rhythm management products with Conexus
Wireless Telemetry. Conexus Telemetry will enhance efficiencies at device
implant and during in-office follow-up visits, as well as enable automatic,
wireless data transmission from the patient's device to a home monitor.
Device data then is transmitted to the clinician using the Medtronic
CareLink Network, the first Internet-based system to help physicians and
patients better manage chronic cardiovascular disease treated by implantable
"Wireless transmission of data on how the device and patient's heart are
operating, coupled with the device's therapeutic and monitoring features,
hold promise for better patient care and more effective device management,"
said Dr. David Schwartzman, associate professor of medicine and director of
the Atrial Arrhythmia Center at the University of Pittsburgh Medical Center,
and principal investigator for the Concerto AT study.
Offering an array of Medtronic-exclusive features to help improve the
care of heart failure patients, the Concerto AT CRT-D device includes:
- Conexus Wireless Telemetry: Utilizing the Medical Implant
Communication Service (MICS) radio frequency band, 402-405 MHz,
Medtronic Conexus Telemetry enables communication between the patient's
implanted device and home monitor or clinician programmer at a range of
two to five meters (approximately six to 16 feet). Communication between
device and monitor can be initiated by the physician based on programmed
device parameters, to occur at pre-scheduled dates and times, or
pre-programmed via the Medtronic CareLink Network. The MICS band is a
dedicated frequency designated by global telecommunications regulatory
authorities, such as the Federal Communications Commission (FCC) in the
United States, for implantable medical device communication. Use of the
MICS band protects Medtronic wireless devices from interference caused
by cell phones and other common electronic devices.
- OptiVol(R) Fluid Status Monitoring: 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 insights that are used in conjunction
with ongoing monitoring of other patient symptoms.
- Left Ventricular Capture Management: LVCM is intended to
automatically sense and adjust impulses for optimal stimulation of the
heart's lower left chamber (ventricle).
- ATP During Charging(TM): Automatically uses pacing pulses to
painlessly stop fast, dangerous heartbeats, while concurrently preparing
to deliver a shock if needed, with no delay. Anti-tachycardia pacing
(ATP) has been clinically proven to eliminate three out of four shocks
with painless pacing therapy.
"The Concerto AT device, with Conexus Wireless Telemetry, represents a
technological turning point for Medtronic and our industry. This system
makes full use of the Medtronic CareLink Network as the cornerstone of our
platform for wireless communication, and transforms CareLink from a device
management tool to a disease management tool," said Steve Mahle, president
of Medtronic Cardiac Rhythm Management.