Medtronic Gets PMA for 3D Wireless ICDs


May 13, 2008

May 13, 2008 - Medtronic received FDA premarket approval (PMA) for the first wave of cardiac rhythm disease management therapies under the new Vision 3D portfolio, which will comprise a full line of implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy-defibrillators (CRT-Ds), pacemakers and cardiac resynchronization therapy-pacemakers (CRT-Ps) 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 CRT-D devices will be commercially available in the coming months. In addition to other Medtronic proprietary features, Vision 3D introduces automaticity with Complete Capture Management, which continuously and automatically adjusts to changing patient needs. Complete automaticity provides physicians flexibility during in-office device checks and may also reduce battery drain.

Other innovations available in the Vision 3D portfolio include:

Conexus Wireless Telemetry is available on all Vision 3D ICDs and CRT-Ds. Through Conexus, patients’device and condition data are automatically transmitted to clinicians and accessible remotely and electronically via the secure Medtronic CareLink Network.

Integrated into all Vision 3D ICDs and CRT-Ds, ATP (anti-tachycardia pacing) During Charging is a Medtronic feature that automatically uses pacing pulses to painlessly stop fast, dangerous heartbeats, while concurrently preparing to deliver a shock if needed, with no delay.

MVP mode, or Managed Ventricular Pacing, is designed to enable doctors to reduce unnecessary pacing to the right ventricle (RV, or the heart’s lower right chamber).

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.

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