ISOLINE

ISOLINETM: Defibrillation Leads

The First in a Long Line of Leaders


  • Steroid Eluting

  • Polyurethane overlay:
    Abrasion resistance1

  • Multi-lumen Technology
    Multi-lumen silicone construction
    Redundant insulation2

  • 7.8 F body lead diameter
    Very good lead handling characteristics3
    Fast lead placement time4

ISOLINE TM 2CR-5/6 with Active Fixation
ISOLINE TM 2CT-5/6 with Passive Fixation

Isodiametric structure

7.8F lead body diameter

Dual Coil

Steroid Eluting

Lengths: 58 cm and 65 cm

EasyTurn  System for Quick Placement5 

EasyTurn  is specially designed for use with ISOLINE active fixation leads, providing:

  • Easy Mapping for optimal positioning before helix extension6
  • Quick Handling position and extend the helix with a single stylet
  • Easy Confirmation of helix extension with X Ray Markers7

 

ISOLINETM  2 CR-5/6  -  Electrical Performance

Internal clinical validation Isoline 2CR-6, nominal values at implant 

 

ISOLINETM  2 CR-5/6  - Technical Data

ISOLINETM  2 CT-5/6  -  Electrical Performance

Internal clinical validation Isoline 2CT-6, nominal values at implant 


ISOLINETM  2 CT-5/6  - Technical Data

 Intended uses, warnings and precautions

 


1.Results in an internal study demonstrate that a similar lead with the same polyurethane overlay, UW28D is at least 201 times more resistant to abrasion in this model than the non-polyurethane coated UC28D lead (465179 / 2312 = 201).

2.Redundant Insulation: ETFE coating, Silicone 3.In clinical evaluations, 100% of investigators had a good or very good overall impression of the Isoline 2CT lead handling characteristics.

3.In clinical evaluations, 83.3% of investigators had a good or very good overall impression of the Isoline 2CR lead handling characteristics.

4. In clinical evaluations, 70% of investigators characterized the lead placement time of Isoline 2CR as fast and 64% of investigators characterize the lead placement time of Isoline 2CT as fast.

5. Isoline Implant Manual N923C Pg 7 item 4&5, Single stylet to position the lead and extend the helix

6. Isoline Implant Manual N923C Pg 7 – item 4&5, Electrical measurements can be made with the stylet in place and the helix retracted

7. Isoline Implant Manual N923C Pg 7, item 6 (8 to 10 turns) and 7, two platinum – iridium radio-opaque markers to enable physicians to see that the helix is fully extended or retracted


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