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Medtronic Announces CE Mark of Viva/Brava Cardiac Resynchronization Therapy Devices

New Devices Automatically Adapt to Patient Needs and Continuously Optimize CRT, Improving Response Rate to Lifesaving Therapy

MINNEAPOLIS – August 20, 2012 – Medtronic, Inc. today announced it has received CE (Conformité Européenne) Mark of its Viva®/Brava® portfolio of cardiac resynchronization therapy with defibrillation (CRT-D) devices. The family of CRT-Ds features a new algorithm, called AdaptivCRT®, which significantly improves heart failure patients’ response rate to CRT-D therapy, as compared to historical CRT trials, by preserving the patients’ normal heart rhythms and by continuously adapting to individual patient needs. AdaptivCRT is only available in the United States for investigational use.

Findings from a new study, which will be presented next week at the European Society of Cardiology’s ESC Congress 2012 in Munich, show that patients’ response to therapy with AdaptivCRT was 12 percent (absolute) higher than in historical CRT trials. In historical trials, heart failure patients had their CRT pacing parameters optimized using time-consuming, echocardiography-guided AV programming, and experienced an average response rate of 66 percent.

“CRT is a highly effective therapy providing significant survival benefit and reducing hospitalization rates for patients suffering from heart failure. However, treatment is not a one-size-fits-all approach, as traditionally one-third of these patients don’t experience symptomatic improvement,” said Jagmeet P. Singh, M.D., Ph.D., director of the cardiac resynchronization program at Massachusetts General Hospital in Boston. “The new AdaptivCRT technology is designed to improve CRT response by automatically providing a new way to deliver and dynamically optimize therapy, offering each patient individualized treatment.”

Until now, attempts to improve patients’ response rates with device timing optimization (echocardiographic-based or device-based) have resulted in modest incremental clinical benefits. These optimization methods are known to be complicated, time-consuming and expensive, and they only measure one point in time rather than continually adjusting to patient needs.

AdaptivCRT optimizes simply and automatically as the algorithm continually adjusts to the patient’s dynamic intrinsic conduction, and enables more natural contractions as it synchronizes ventricular contraction. In addition, patients in the AdaptivCRT study with the algorithm experienced a reduction in right ventricular pacing by 44 percent, thus reducing unnecessary right ventricular pacing and extending the longevity of CRT-D devices.

“The Viva/Brava family of devices offers clinicians and their patients a new approach to CRT treatment, providing therapeutic benefit and individualized care for patients,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. “AdaptivCRT enables us to deliver CRT differently, allowing for greater efficiency and ensuring maximum treatment response.”

The Viva/Brava CRT devices are designed to promote patient comfort by reducing skin pressure by 30 percent compared to most other CRT devices.1 The design also provides additional longevity for the devices. Other features of the new CRT portfolio include:

  • Ensure CRT suite with Cardiosync® In-Office Optimization, which works to maximize CRT treatment, even during atrial fibrillation.
  • SmartShock™ Technology, which includes six Medtronic-exclusive algorithms that recognize life-threatening arrhythmias but deliver therapeutic shocks only when appropriate.
  • OptiVol® 2.0 Fluid Status Monitoring, which measures changes in fluid build-up in heart failure patients to identify patients at risk of worsening heart failure.

In a randomized Medtronic study, which was published online this month in Heart Rhythm, AdaptivCRT met its pre-specified safety and efficacy endpoints of non-inferiority as compared to the gold-standard comprehensive echocardiography-guided biventricular pacing. These results are part of the PMA submission for AdaptivCRT that is under regulatory review by the U.S. Food and Drug Administration (FDA).

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias.

About Medtronic
Medtronic, Inc. (www.medtronic.com), 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 periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

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1 CRT-D DF4 Device Shape Analysis. April 2012. Medtronic Data on File.
Medtronic Media Contacts:
Kathleen Janasz, Public Relations, 763-526-3676
Jeff Warren, Investor Relations, 763-505-2696
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