Cardiology, patient monitoring  

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.

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