Healthcare Industry News: CareLink Network
News Release - May 17, 2006
Medtronic Receives FDA Approval for New Cardiac Systems with Distance Wireless Telemetry
Concerto CRT-D and Virtuoso ICD Transmit Patient Data Remotely and Automatically to Physicians, Enabling Better CareMINNEAPOLIS--(HSMN NewsFeed)--May 17, 2006--Medtronic, Inc., (NYSE:MDT ) today announced United States Food and Drug Administration approval of the Medtronic Concerto(TM)/Virtuoso(TM) line of implantable cardiac devices, Medtronic's next generation of cardiac rhythm disease management products. The approval coincides with Heart Rhythm 2006, the Heart Rhythm Society's 27th Annual Scientific Sessions - the pre-eminent gathering of medical professionals from across the globe who specialize in the heart's rhythms and electrical function. Market availability of these devices will follow in June 2006.
The Concerto cardiac resynchronization therapy-defibrillator (CRT-D) and Virtuoso implantable cardioverter defibrillator (ICD) are the first implantable cardiac devices available with Medtronic's proprietary Conexus(TM) Wireless Telemetry, developed using the Medical Implant Communications Service (MICS, 402-405 MHz). Using the MICS band enables reliable communication between the implanted device and clinician programmers and patient home monitoring units.
Conexus Telemetry will enhance efficiencies at device implant and during in-office follow-up visits. At implant, there is no need for the programmer head to enter the sterile implant field, and in-office visits may be simplified when they're needed, as the physician can interrogate patients' devices via wireless telemetry without the need for surface electrodes. As well, Conexus Telemetry will enable automatic, wireless data transmission from the patient's device to a home monitor. Device data then will be 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. Communication between device and monitor will be initiated by physician-programmed device parameters or it can occur on pre-scheduled dates that are pre-programmed via the Medtronic CareLink Network. If the system detects notable changes in the patient's condition or device status, a Medtronic CareAlert(TM) will be sent to the physician, providing the potential for treatment decisions before the condition worsens.
"Implantable device therapy is entering a new era with innovation focused on overall cardiac disease management and enhancing patient quality of life," said Charles Haffajee, M.D., director of Cardiac Electrophysiology, Arrhythmia and Pacing at Caritas St. Elizabeth's Medical Center in Boston. "This system's features, in combination with wireless distance telemetry, offer more convenient, yet equally effective, device management and patient care."
The Virtuoso ICD 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 resynchronize the contractions of the heart's lower chambers, helping the heart pump blood throughout the body more efficiently. Other features include:
- Conexus Wireless Telemetry with SmartRadio(TM): Utilizing the MICS radio frequency band, 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 (approximately six to 16 feet). The MICS band is a frequency designated by global telecommunications regulatory authorities, such as the Federal Communications Commission, for implantable medical device communication. Use of the MICS band protects Medtronic wireless devices from interference caused by cell phones and other common wireless 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 insights used in conjunction with ongoing monitoring of other patient symptoms. Previously available on the Medtronic InSync Sentry(TM) CRT-D device, OptiVol is now available to Virtuoso ICD patients as well as Concerto CRT-D patients.
- Left Ventricular Capture Management: LVCM, available on the Concerto CRT-D, is intended to automatically sense and adjust impulses for optimal stimulation of the heart's lower left chamber (ventricle) and ensure cardiac resynchronization therapy.
- 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. Medtronic PainFREE(TM) Therapy has been clinically proven to eliminate three out of four shocks with painless pacing therapy. ATP During Charging is now available for both CRT-D and ICD patients.
- Managed Ventricular Pacing: MVP(TM) Mode, available on the Virtuoso DR (dual chamber) ICD, promotes intrinsic conduction and reduces right ventricular pacing by 99 percent (median).
"Packaging remote and wireless patient monitoring with several of Medtronic's other market-exclusive features into the Concerto/Virtuoso line of implantable devices represents the best industry has to offer in cardiac rhythm and disease management," said Steve Mahle, president of Medtronic Cardiac Rhythm Disease Management.
Heart failure afflicts 5 million Americans and is the number one cause of hospital admissions, with most of these admissions due to fluid accumulation in the thorax. This fluid buildup often goes undetected until the patient is critically ill, and it is not unusual for patients to require hospitalization or urgent treatment at an emergency room for severe respiratory distress. With approximately 1 million hospitalizations each year for heart failure, heart failure management is a tremendous cost burden to the country's healthcare system.
For more information about the Concerto/Virtuoso line of implantable cardiac devices with Conexus Wireless Telemetry, visit www.MedtronicConexus.com.
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Quarterly Report on Form 10-Q for the quarter ended January 27, 2006. Actual results may differ materially from anticipated results.
Source: Medtronic
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