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Medtronic’s Vision 3D Wireless ICD received FDA approval

Medtronic : 14 May, 2008  (New Product)
Medtronic has announced US FDA approval of the first wave of cardiac rhythm disease management therapies under the new Vision 3D portfolio.
The new product range comprises a full line of implantable cardioverter­defibrillators (ICDs), cardiac resynchronization therapy­defibrillators (CRT­Ds), pacemakers and cardiac resynchronization therapy­pacemakers (CRT­Ps) to address the needs of patients with arrhythmias, heart failure and those at risk of sudden cardiac arrest (SCA).

The portfolio’s first ICD and CRT­D devices will be commercially available in the coming months. “Our customers prefer wireless devices and want choices for different clinical situations,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business at Medtronic. “The new Vision 3D wireless ICD and CRT­D therapies offer unparalleled depth and breadth of unique clinical options that are built on our industry­leading, exclusive technologies.”

In addition to other Medtronic proprietary features, Vision 3D introduces automaticity with Complete Capture Management, which provides confidence in patients’ safety by continuously and automatically adjusting to changing patient needs. Complete automaticity provides physicians flexibility during in­office device checks and may also reduce battery drain.

“For the first time, we have access to sophisticated defibrillators with complete automaticity to capture what’s happening in three chambers of the heart and adjust the device’s stimulation to the body’s physiologic needs,” said Anne Curtis, MD, FHRS, FACC, FAHA, chief of the Division of Cardiology and director of Cardiovascular Services at the University of South Florida. “This also gives us insight into key trend data to help better manage the patient’s condition, rather than simply inform us how the implanted device is operating.”

Other state­of­the art Medtronic innovations available in the Vision 3D portfolio include:

- Conexus Wireless Telemetry, the industry’s most­used system serving more than 100,000 patients globally, is available on all Vision 3D ICDs and CRT­Ds. Through Conexus, patients’ device and condition data are automatically transmitted to clinicians and accessible remotely and electronically via the secure Medtronic CareLink Network. More than 250,000 patients at nearly 2,400 clinics in 20 countries are followed remotely on the Medtronic CareLink Network.

- Medtronic’s PainFREE strategy for shock reduction, including ATP (anti­tachycardia pacing) During Charging. Integrated into all Vision 3D ICDs and CRT­Ds, ATP During Charging is a Medtronic exclusive feature that automatically uses pacing pulses to painlessly stop fast, dangerous heartbeats, while concurrently preparing to deliver a shock if needed, with no delay. The PainFREE strategy to stop fast heartbeats has been clinically proven to eliminate three out of four shocks with painless therapy, potentially improving patient quality of life . Clinical studies have shown that 90 percent of fast heart rhythms have the potential to be terminated by pacing alone.

- Medtronic’s MVP mode, or Managed Ventricular Pacing, allows doctors to dramatically reduce unnecessary pacing to the right ventricle (RV, or the heart’s lower right chamber). Medtronic is the only company with proven benefits of minimizing unnecessary RV pacing: the Medtronic­sponsored SAVE PACe trial, which was published in The New England Journal of Medicine, showed the benefits of Medtronic’s technology in reducing the risk of developing persistent atrial fibrillation (AF) .

- OptiVol Fluid Status Monitoring, a Medtronic feature that measures intrathoracic impedance in heart failure patients. Using very low electrical pulses that travel across the thoracic cavity (the chest area encompassing the heart and lungs), the system can measure the level of resistance to the electrical pulses, which indicates fluid levels. Used in combination with the company’s Heart Failure Management Report, OptiVol’s ability to manage fluid status over time can provide physicians with important insights in conjunction with ongoing monitoring of other patient symptoms, which may lead to timely clinical intervention. Currently there are more than 125,000 patients implanted with this exclusive technology, globally.
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