Wednesday, May 14, 2008

Medtronic 3D Vision Line Gets First FDA Approvals

Filed under: Cardiac Surgery , Cardiology , Radiology

Medtronic received FDA approval for the company's wireless implantable defibrillators, the first devices in a product line that also includes pacemakers and resynchronization therapy pacemakers.

Leading into Heart Rhythm 2008, the pre-eminent worldwide gathering of cardiologists specializing in electrophysiology, Medtronic, Inc... announced U.S. Food and Drug Administration (FDA) approval of 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 provides confidence in patients’ safety by continuously and automatically adjusting to changing patient needs. Complete automaticity provides physicians flexibility during in-office 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, M.D., 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 state-of-the art Medtronic innovations available in the Vision 3D portfolio include:

Automaticity with Complete Capture Management™, which provides confidence in patients’ safety by continuously and automatically adjusting to changing patient needs.

Conexus® Wireless Telemetry, the industry’s most-used system, is available on all Vision 3D ICDs and CRT-Ds.

Medtronic’s PainFREE™ strategy to stop fast heartbeats, which has been clinically proven to eliminate three out of four shocks with painless therapy, potentially improving patient quality of life.

Medtronic’s MVP® mode, or Managed Ventricular Pacing, which allows doctors to dramatically 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.

The following "backgrounder" about its Vision 3D portfolio was distributed by Medtronic to the media:

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