Medtronic Launches First Wireless Devices In Japan -Concerto® CRT-D And Virtuoso® ICD Now Available For Japanese Patients

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics
Article Date: 17 Jul 2007 - 1:00 PDT

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Medtronic, Inc. (NYSE: MDT) announced the commercial launch of its latest cardiac resynchronization therapy-defibrillator, the Concerto® CRT-D, and its latest implantable cardioverter-defibrillator, the Virtuoso® ICD. Both devices are the first of their kind in Japan equipped with key features, including wireless telemetry.

ICDs are implanted medical devices used to detect sudden, potentially fatal arrhythmias and automatically deliver therapies to restore the normal rhythm of the heart. CRT-D devices are equipped with the functions of an ICD while also providing cardiac resychronization therapy for patients suffering from heart failure, in which the left and right ventricles (lower chambers) of the heart fail to provide a synchronized beat. In addition to the above functions, the Concerto and Virtuoso are the first devices in Japan with three new features.

Wireless Functionality Reduces Time Needed for Follow-Ups and Procedures

Implanted devices such as pacemakers and ICDs are capable of internally recording the patient's pulse, device therapies delivered, and other similar data over a certain period of time. This information is then obtained by the patient's doctor during in-office follow-up visits every three to four months and used to determine the patient's subsequent treatment and therapies. Conventional devices require an in-office visit where a reader is placed over the implanted device to allow for transfer of this data; the Concerto and Virtuoso provide this information wirelessly, precluding the need for patients to disrobe. Changes to certain device settings can also be performed using the wireless function. Additionally, the initial settings programmed during device implant can be performed wirelessly, avoiding the placement of the programming head in the sterile field ordinarily used for this function, thereby potentially reducing the time for surgical procedures.

Reducing Shocks Minimizes Patient Burden

ICDs detect and provide therapy to terminate dangerous arrhythmias. This therapy may take the form of anti-tachycardia pacing (ATP) or electrical shock (known as defibrillation). ATP is a mild and relatively painless form of therapy compared to a shock, which may be uncomfortable, and can cause the patient to experience apprehension or fear. The Concerto and Virtuoso are capable of delivering ATP while simultaneously charging the capacitor (ATP During Charging™) to provide a shock, if needed. This means that if the arrhythmia is not terminated using ATP, the devices are able to deliver the electrical shock with no delay, giving patients access to the safe, painless ATP therapy while minimizing patient burden.

Measuring Impedance in the Thoracic Cavity and Reporting Symptoms to Physician

Heart failure patients may experience fluid building up in their lungs, leading to a worsening condition. The Concerto and Virtuoso are the first devices in Japan capable of measuring the impedance in the thoracic cavity between the device implanted below the clavicle and the lead implanted in the ventricle, allowing the device to record the level of fluid in the patient's lungs. The OptiVol® Fluid Status Monitoring diagnostic feature allows physicians earlier access to warning signs of deteriorating heart failure, which can then be used for early treatment of the patient's heart failure.

In addition to the regular CRT-D and ICD functions of the Concerto and Virtuoso, the introduction of the above three features in Japan may allow for improved quality-of-life for heart failure and high-risk arrhythmia patients.

"It is significant that today Japanese patients have access to the latest Medtronic devices, the Concerto CRT-D and Virtuoso ICD," said Steve Mahle, president of Medtronic's Cardiac Rhythm Disease Management business. "In the past, Japanese physicians often had to wait extended periods of time before being able to offer their patients the newest device therapies such as wireless telemetry. But in working closely with the Ministry of Health, Law and Welfare, we are able to safely bring these products to market to benefit thousands of Japanese patients with heart failure and arrhythmias."

Concerto and Virtuoso Main Features

First devices in Japan equipped with Medtronic's exclusive Conexus® Wireless Telemetry

-- Feature uses official MICS (Medical Implant Communication Service) bandwidth at 402-405 megahertz, preventing interference from cell phones and other common electronic devices.
-- SmartRadioTM function automatically switches channels when noise interference is detected, allowing for safe wireless data transmission.

First devices in Japan with ATP During Charging™

-- Anti-tachycardia pacing can be performed during charging of the capacitor to provide a shock.

First devices in Japan with Medtronic's proprietary Optivol® Fluid Status Monitoring

-- Thoracic impedance measured 64 times daily; daily average recorded by device.
-- Device stores data for up to 14 months and is capable of providing a report at follow-up.

About Medtronic

Medtronic, Inc. headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.

http://www.medtronic.com

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