Medtronic initiates 50-site study of defibrillator with wireless telemetry

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 device therapy.

"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.

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