Tendril MRI™ Pacing Lead
CARDIOVASCULAR
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Tendril MRI

Pacing Lead

Tendril MRI™ Pacing Lead

PRODUCT HIGHLIGHTS

Product Highlights - Pacing Leads

The Tendril MRI™ lead is designed to allow patients to undergo MRI scans.

  • When combined with the Assurity MRI™ pacemaker
    • Allows full-body MRI scans in either normal mode or first level control mode*
  • Utilizes a unique, dual filtering system that has been shown to minimize lead-tip heating1
  • Soft silicone tip offers more compliance at the lead tip-endocardium interface
    • The soft silicone tip on the Tendril MRI lead reduces tip pressure by approximately > 30% over 6 F leads without a soft silicone tip.2,3 Though the soft silicone increases the surface area of the lead tip to 9 F, the Tendril MRI lead still fits through an 8 F introducer due to the material’s soft nature. Four pads on the silicone tip further increase the surface area of the lead tip that is in contact with the tissue
  • Optim™ lead insulation—a chemical co-polymer that blends the best features of polyurethane and silicone—provides improved handling and increased durability
  • Limited lifetime warranty**

ORDERING INFORMATION


Reorder Number Description Insulation Fixation Minimum Introducer (F) Connector Lengths (cm)
LPA1200M/46 Tendril MRI Pacing Leads Optim™ Ext/Ret helix 8 IS-1 bipolar 46
LPA1200M/52 Tendril MRI Pacing Leads Optim™ Ext/Ret helix 8 IS-1 bipolar 52
LPA1200M/58 Tendril MRI Pacing Leads Optim™ Ext/Ret helix 8 IS-1 bipolar 58
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1. Liu Y, Li D, Chen J. RF Lead Heating of MRI-Conditional Pacemaker Systems. Poster session presented at EuroPace. Athens, Greece. June 2013.

2. Mechanical & System Verification Test Report - Tendril 1888. St. Jude Medical. Report No. 50009843.

3. Mechanical & System Verification Test Report - Tendril STS 2088. St. Jude Medical. Report No. 50025428.

* See MRI Conditional Parameters

**Terms and conditions apply. Refer to the warranty for details.


Rx Only                                                                                                                                    Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

 Product is CE marked.

 MP35N is a trademark of SPS Technologies, LLC.

 

Indications: The Tendril MRI™ lead is designed for permanent sensing and pacing in either the right atrium or the right ventricle, in combination with a compatible device.

Active leads such as the Tendril MRI lead may be indicated for patients where permanent fixation of passive leads is suspected to be unstable. In atrial applications, the use of a screw-in lead such as Tendril MRI lead may be indicated in the presence of an abnormal, surgically altered or excised atrial appendage.

This is an MR Conditional lead.

MR Conditional Pacing System: The St. Jude Medical™ MRI conditional lead is part of the St. Jude Medical™ MRI conditional pacing system. Patients with an implanted St. Jude Medical™ MRI conditional pacing system can have an MRI scan if the conditions for use, as described in the MRI Procedure Information document, are met.

Contraindications: The Tendril MRI™ lead is contraindicated in the presence of tricuspid atresia, for patients with mechanical tricuspid valves, and in patients who are expected to be hypersensitive to a single dose of one milligram of dexamethasone sodium phosphate.

Adverse Events: Potential complications associated with the use of Tendril MRI leads are the same as with the use of other active fixation leads and include: perforation of the myocardium, cardiac tamponade, phrenic nerve stimulation, dislodgement of the pacing lead, embolism, temporary or permanent loss of stimulation and/or sensing, infection, valve and/or vessel damage, tissue necrosis.

Refer to the User’s Manual for more detailed indications, contraindications, warnings, precautions and potential adverse events.

SJM-TND-0914-0001(1)

Last Updated: January 02, 2019

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Reorder Number Description Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector
PM1272 Assurity MRI Pacemaker 47 x 50 x 6 20 10.4 (± 0.5) IS-1
PM2272 Assurity MRI Pacemaker 47 x 50 x 6 20 10.4 (± 0.5) IS-1
PM1172 Endurity MRI™ Pacemaker 41 x 50 x 6 19 9,7 (± 0,5) IS-1
PM2172 Endurity MRI™ Pacemaker 46 x 50 x 6 20 10,4 (± 0,5) IS-1