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Devices Cardiology FDA

 News Release - May 13, 2008

Medtronic Announces FDA Approval of New Vision 3D Wireless Implantable Cardiac Devices

Portfolio Includes the Industry's First Defibrillators with Complete Automaticity

MINNEAPOLIS & SAN FRANCISCO--(HSMN NewsFeed)--Leading into Heart Rhythm 2008, the pre-eminent worldwide gathering of cardiologists specializing in electrophysiology, Medtronic, Inc. (NYSE: MDT ) today 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.

“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 CRT-D therapies offer unparalleled depth and breadth of unique clinical options that are built on our industry-leading, 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 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:

  • Conexus® Wireless Telemetry, the industry’s most-used system serving more than 100,000 patients globally, 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. 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 (anti-tachycardia pacing) During Charging™. Integrated into all Vision 3D ICDs and CRT-Ds, 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 life1. 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 Medtronic-sponsored 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)2.

  • 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.

About Sudden Cardiac Arrest

Every three minutes someone in the U.S. dies from sudden cardiac arrest (SCA)3. ICDs are stopwatch-sized medical devices that are implanted in the chest area with leads (thin wires) extending to the heart, where they administer electrical therapies to stop the dangerous ventricular arrhythmias that can lead to sudden cardiac arrest.

About Heart Failure

Heart failure affects more than 22 million people worldwide, including 5 million Americans, and accounts for nearly $80 billion in cost each year worldwide.4 It is also a leading cause of hospitalization among people aged 65 years and older, and admissions for its symptoms have increased by 15 percent over the last 20 years.5 In cardiac resynchronization therapy, a stopwatch-sized device is implanted in the upper chest in an attempt to resynchronize the contractions of the ventricles (lower chambers of the heart) by sending tiny electrical impulses to the heart muscle. Resynchronizing the contractions of the ventricles can help the heart pump blood throughout the body more efficiently and reduce the symptoms. Cardiac resynchronization therapy, also known as biventricular pacing, is intended to complement standard drug treatment, and dietary and lifestyle modifications.

About Arrhythmias

Arrhythmias are simply irregular heart rhythms in the heart’s atria (upper chambers) or ventricles (lower chambers). They can be dangerously fast heart rhythms, known as tachycardia or tachyarrhyhmias; dangerously slow rhythms, known as bradycardia or bradyarrhythmias; fibrillation, where the heart quivers instead of pumping blood effectively to the body; or asystole, which is the absence of electromechanical activity within the heart.


1 Wathen MS, DeGroot PJ, Sweeney MO, et al, for the PainFREE Rx II Investigators. Prospective randomized multicenter trial of empirical antitachycardia pacing versus shocks for spontaneous rapid ventricular tachycardia in patients with implantable cardioverter defibrillators: Pacing Fast Ventricular Tachycardia Reduces Shock Therapies (PainFREE Rx II) trial results. Circulation. October 26, 2004;110(17):2591-2596.

2 Sweeney MO, Bank AJ, Nsah E, et al. Minimizing ventricular pacing to reduce atrial fibrillation in sinus-node disease. N Engl J Med. September 6, 2007;357(10):1000-1008.

3 Heart disease and stroke statistics--2008 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2008 Jan 29;117(4):e25-146.

4 Medtronic data on file, Jan 2007 (statistics as indicated in the guidelines from the European Society of Cardiology)

5 G Yao, N Freemantle, MJ Calvert, S Bryan, JC Daubert, JGF Cleland, “The long-term cost-effectiveness of cardiac resynchronisation therapy with or without an ICD: European Heart Journal Advance Access published November 16, 2006.

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.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 27, 2007. Actual results may differ materially from anticipated results.

Source: Medtronic

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