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Now two generations ahead in pacemakers approved for MRI
The Advisa DR MRI™ SureScan® Model A3DR01 and Advisa SR MRI™ SureScan® Model A3SR01 IPGs are indicated for use as a system. A complete SureScan pacing system, which consists of an approved combination MRI SureScan device with SureScan lead(s), is required for use in the MRI environment.
It is estimated that up to 75% of pacemaker patients will have a medical need for an MRI over the lifetime of their device.3
Convergence of Needs: MRI and Pacemakers
Elderly patients are the primary users of MRI. Individuals over age 65 are twice as likely to need an MRI compared to younger patients.4
The potential need for a pacemaker also increases with age.
Comprehensive Patient Care
Medical and surgical specialties rely on MRI for diagnosis. In fact, MRI is the gold standard diagnostic tool for soft tissue imaging for neurologists, oncologists, and orthopaedic surgeons. Your pacemaker choice today can affect their decisions and diagnostic capabilities tomorrow.
The prevalence of common comorbidities increases over age 65,5-7 often requiring MRI – the same population most likely to require a pacemaker.
The Advisa MRI Pacing System with SureScan® technology has met the rigors of clinical evaluation, regulatory review, and FDA approval.
The Advisa MRI Pacemaker Was Specifically Engineered for the MRI Environment
Multiple safety features were designed and incorporated from the ground up:
Four SureScan Lead Options That Are Proven Safe and Effective in the MRI Environment
The four available SureScan lead options:
Over 3.2 M 5076 leads have been sold worldwide with over 97.6% reliability at 10 years.8
For additional information on SureScan Pacing Systems, please visit www.mrisurescan.com
Managed Ventricular Pacing (MVP) is exclusive to Medtronic devices. It is the only mode-switching technology that reduces unnecessary RV pacing by 99%.1
Multicenter (63 centers) international, randomized single blind study with 3 arms enrolling 1,166 patients with:
49% relative reduction (p = 0.001) in cardioversions
for atrial arrhythmias between DDDRP + MVP and
52% relative reduction (p < 0.0001) in AF-related
hospitalizations and ER visits between DDDRP + MVP
and Control DDDR
Potential Contribution of Reactive ATP®
Risk of AF > 7 days and aATP efficacy
|Inner / Outer Insulator||Silicone||Silicone|
|Body||6.1 Fr||7 Fr|
|Recommended Introducer Size||9 Fr with guidewire
7 Fr without guidewire
|11 Fr with guidewire
8 Fr without guidewire
|Tip-to-Ring Spacing||10 mm||10 mm|
|Standard Lengths||35, 45, 52, 58, 65, 85 cm||45, 52, 58 cm|
|Approved MR Conditional Devices||Advisa DR MRI™ A2DR01, Advisa SR MRI™A3SR01||Advisa DR MRI™ A2DR01, Advisa SR MRI™A3SR01|
IMPORTANT INFORMATION ON INDICATIONS, SAFETY AND WARNINGS
For listing of Indications, Contraindications, Warnings, Precautions, and Potential Adverse Events, please refer to the Instructions For Use .