Medtronic Receives FDA Approval For New Cardiac Systems With Distance Wireless Telemetry
Minneapolis - Medtronic, Inc., announced United States Food and Drug Administration approval of the Medtronic Concerto/Virtuoso 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 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.
"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.
SOURCE: Medtronic, Inc.