CapSure Sense MRI^TM SureScan^® Leads

Complete MRI Pacing Lead Portfolio

• The CapSure Sense MRI and CapSureFix MRI leads comprise a complete MRI lead portfolio with passive and active fixation options that can be used individually or in combination

World’s Smallest MRI Lead

• The CapSure Sense MRI leads are the world’s smallest MRI leads with a 5.3 French isodiametric lead body

MRI Access for More Patients

• The only passive MRI lead that allows for safe MRI full body scanning
• Expands MRI access to patients currently implanted with CapSure Sense leads (with MR-conditional lengths)

Proven Lead Experience

CapSure Sense Lead Portfolio

• Proven performance and 10 years of implant experience ²
• More than 420,000 leads have been sold worldwide³
• 99% reliability after six years²

MRI Conditions for Use

Non-clinical testing has demonstrated that the SureScan pacing system is safe for use in the MRI environment when used according to the instructions in the technical manual.

The SureScan pacing system can be scanned in patients under the following conditions:

• Do not direct drive lead with fully seated stylet into resistive cardiac structures
• Cylindrical bore magnet, clinical MRI systems with a static magnetic field of 1.5 T (tesla) must be used.
• Whole body averaged specific absorption rate (SAR) as reported by the MRI equipment must be ≤ 2.0 W/kg; head SAR as reported by the MRI equipment must be < 3.2 W/kg.
• Patients and their implanted systems must be screened per the contraindications in Section 4 of the Technical Manual.
• Continuous patient monitoring must be provided as described in Section 6.3 of the Technical Manual.
• The patient must be positioned according to the contraindications described in Section 4 of the Technical Manual.
• There are no patient positioning restrictions relative to the MRI isocenter landmark when using the body coil.
• There are no patient positioning restrictions relative to the use of any receive-only coils.
• The implanted system must consist solely of a SureScan device and SureScan leads as described in Section 7.1 of the Technical Manual.

Implanting the CapSure Sense MRI^® Lead Models 4074 and 4574

General considerations for fixation of passive leads

• Stylet should be at least 2 cm retracted from lead tip as lead approaches heart wall.
• When distal end of lead buckles, heart wall contact is confirmed. Stop forward pressure when this is seen.

  

• Angling RV lead tip slightly toward apical-septum with counter-clockwise turn to stylet will position lead tip in slightly thicker heart tissue (5-10mm) and slightly more natural electrical path than apical- free-wall provides

  

• Confirm appropriate slack

General considerations for fixation of passive leads in the right atrium

• Passive fixation atrial leads are pre-shaped in a J configuration.
• Straight stylets are inserted to introduce the RA lead into the atrium
• As stylet is retracted, apply a clockwise torque to the lead to drive the “J” shape into the appendage trabeculae

  

  Clockwise torque applied to atrial lead as stylet is withdrawn. This allows “J” shape of atrial lead to get positioned in the trabeculae of the appendage. AP view shown.

Manuals for the SureScan^® Pacing Systems can be found at http://manuals.medtronic.com/

References:
1 – Magnetic resonance imaging in patients with a pacemaker system designed for the magnetic resonance environment. Wilkoff BL, Bello D, Taborsky M, et al. Heart Rhythm. January 2011; 8(1): 65 -73.
2 – Medtronic Product Performance Report, 2011 First Edition, Issue 64.
3 – Medtronic Data on File

Product Availability
The SureScan^® Pacing System may not be available in your country. Please contact your local Medtronic sales representative for more information.