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8/14/2019 Vision 3D Backgrounder
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BACKGROUNDER
The Medtronic Vision 3D Portfolio
OverviewThe Vision 3D wireless ICD and CRT-D portfolio offers unparalleled depth and breadth ofunique clinical options that are built on our industry leading pacing and ICD exclusives. It is the
industrys most comprehensive family of wireless implantable heart devices.
The portfolio brings together Medtronics state-of-the-art cardiac rhythm device technology toprovide 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, exclusivetechnologies allow physicians to select the right product with the right features for eachpatients individual health needs.
Enhanced Feature Depth Patients have access to Medtronics proprietary features acrossthe 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 fatalrhythm.
Disease Management data collection and reporting of up to 14 months of clinical deviceinformation, including arrhythmia episodes, therapies delivered, physical activity, pacing
activity and fluid levels, to help better manage the patients 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 withdysynchronous heart.
Remote Patient Care collection and reporting of device data through the secure CareLinkremote monitoring network, which allows information to be sent to patients cardiologist via
a standard phone line, potentially reducing office visits and providing timely alerts to theclinician if a problem arises.
Personalized Care
Medtronics Vision 3D portfolio allows physicians to specify the unique feature options needed to
meet their patients individual needs. These products continue Medtronics legacy of leadership inthe industry by delivering products based on customer feedback and mounting clinical evidence,including:
MVP, or Managed Ventricular Pacing available since 2004, allows doctors to dramaticallyreduce unnecessary pacing to the right ventricle, or the hearts lower right chamber, and is
included in all Vision 3D ICDs.
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OptiVol Fluid Status Monitoring a Medtronic exclusive feature that has been available since2004, 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
8/14/2019 Vision 3D Backgrounder
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companys Heart Failure Management Report, OptiVols 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 industrys most-used system serving more than 100,000patients 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 atnearly 2,400 clinics in 20 countries are followed remotely on the Medtronic CareLink Network.
ATP During Charging available since 2005, this Medtronic exclusive automatically usespacing 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 shownthat 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 tocapture what is happening in the three chambers of the heart, and then adjust the devices
programming to better fit the bodys 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 latestclinical evidence and is available on all Vision 3D ICDs and CRT-Ds.
Detailed EGM Viewer the first diagnostic tool that displays high fidelity electrograms, orEGMs, 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 StatusIn 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 approximately500,000 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 Medtronicpacemaker or defibrillator.
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Medtronic Media Contacts:
Tracy McNulty: 763-514-4553
Catherine Peloquin: 763-526-2494