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The Medtronic Vision 3D Portfolio
Overview The Vision 3D™ wireless ICD and CRT-D portfolio offers unparalleled depth and breadth of unique clinical options that are built on our industry leading pacing and ICD exclusives. It is the industry’s most comprehensive family of wireless implantable heart devices. The portfolio brings together Medtronic’s state-of-the-art cardiac rhythm device technology to provide physicians and patients the devices, services and remote monitoring needed to meet individual therapy goals: • Increased Choice of Product – Device options built on industry-leading, exclusive technologies allow physicians to select the right product with the right features for each patient’s individual health needs. • Enhanced Feature Depth – Patients have access to Medtronic’s proprietary features across the portfolio of products. Vision 3D Portfolio Fundamentals The portfolio includes key Medtronic-proprietary features, which serve as foundational elements across the group: • Shock Reduction – the devices use pacing pulses to painlessly stop dangerous rhythms, while simultaneously preparing to deliver a shock, if needed, to terminate a potentially fatal rhythm. • Disease Management – data collection and reporting of up to 14 months of clinical device information, including arrhythmia episodes, therapies delivered, physical activity, pacing activity and fluid levels, to help better manage the patient’s heart disease. • Therapy Efficacy – providing effective therapy when needed, whether significantly reducing unnecessary pacing to the right ventricle, or ensuring delivery of CRT for patients with dysynchronous heart. • Remote Patient Care – collection and reporting of device data through the secure CareLink remote monitoring network, which allows information to be sent to patient’s cardiologist via a standard phone line, potentially reducing office visits and providing timely alerts to the clinician if a problem arises. Personalized Care Medtronic’s Vision 3D portfolio allows physicians to specify the unique feature options needed to meet their patients’ individual needs. These products continue Medtronic’s legacy of leadership in the industry by delivering products based on customer feedback and mounting clinical evidence, including: • MVP®, or Managed Ventricular Pacing – available since 2004, allows doctors to dramatically reduce unnecessary pacing to the right ventricle, or the heart’s lower right chamber, and is included in all Vision 3D ICDs. • OptiVol® Fluid Status Monitoring – a Medtronic exclusive feature that has been available since 2004, OptiVol measures intrathoracic impedance in heart failure patients. Using very low electrical pulses that travel across the thoracic cavity, the system can measure the level of resistance to the pulses, which correlates with fluid levels. Used in combination with the 1
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. 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. ATP During Charging™ – available since 2005, this Medtronic exclusive automatically uses pacing pulses to painlessly stop fast, dangerous heartbeats, while simultaneously preparing to deliver a shock if needed to terminate a potentially fatal rhythm. Clinical studies have shown that 90 percent of fast heart rhythms have the potential to be terminated by pacing alone. This feature is available in all Vision 3D ICDs and CRT-Ds.
Some models also will include new industry-first features: • Automaticity with Complete Capture Management™ – provides doctors with the ability to capture what is happening in the three chambers of the heart, and then adjust the device’s programming to better fit the body’s physiologic needs. Complete automaticity also provides physicians flexibility during in-office checks and may enhance device longevity. • Therapy-Guide™ – helps match patient-based programming recommendations against the latest clinical evidence and is available on all Vision 3D ICDs and CRT-Ds. • Detailed EGM Viewer – the first diagnostic tool that displays high fidelity electrograms, or EGMs, of symptomatic events with enhanced morphological quality for classifying arrhythmias and viewing EGM changes such as P-wave and R-wave. • Enhanced Patient Alert™ – this enhanced audible tone is approximately three times lower. Regulatory Status In April 2008, Medtronic received European (CE Mark) and U.S. Food and Drug Administration (FDA) regulatory approval for the first wave of devices under the Vision 3D portfolio, which includes six single and dual chamber implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapy-defibrillators (CRT-Ds). Device Implant Statistics • Approximately 1.5 million Americans have a pacemaker or CRT-P today, and approximately 500,000 Americans have an ICD or CRT-D today (all manufacturers). • We estimate that worldwide, more than 2.4 million people are currently living with a Medtronic pacemaker or defibrillator. ###
Medtronic Media Contacts: Tracy McNulty: 763-514-4553 Catherine Peloquin: 763-526-2494