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Optim™ Insulation

Optim Insulation, the first co-polymer insulation created specifically for cardiac lead use, combines the flexibility and biostability of silicone with the lubricity and durability of polyurethane.
Durata™ Defibrillation Lead
Overview

Optim Insulation is an innovative co-polymer material that fuses the best attributes of silicone and polyurethane. Cardiac leads with Optim Insulation offer improved cardiac lead lubricity that potentially provides a smoother implant, especially with multiple leads in one vein. It also offers improved handling, increased durability and proven biostability.

Innovative Material

A silicone-polyurethane insulation created specifically for cardiac lead use. This new material blends the biostability and flexibility of silicone with the durability, lubricity and abrasion-resistance of polyurethane.

Improved Lubricity

Bench tests of the Optim Insulation (SPC) with Fast-PassTM coating showed less frictional value than silicone or polyurethane. A cardiac lead with Optim insulation potentially provides a smoother implant than that of a silicone or polyurethane lead, especially with multiple leads in one vein.

Optim Insulation Lubricity

Improved Flexibility

In bench testing, Optim (SPC) lead tip stiffness was considerably less stiff than 55D polyurethane (Pellethane†) and similar to silicone rubber.

Optim Insulation Flexibility

Increased Durability

Bench tests revealed that the new Optim Insulation (SPC) with Fast-Pass coating is more resistant to abrasion in "lead-on-lead" contact testing than silicone rubber and offers increased durability.

Optim Insulation Durability
Jenney C, Tan J, Karicherla A, Burke J, Helland J. A New Insulation Material for Cardiac Leads with Potential for Improved Performance, HRS 2005, HeartRhythm, 2, S318-S319 (2005).

Proven Biostability

After two years of implantation, the Optim (SPC) material has shown biostability at least as good as 55D polyurethane (Pellethane).
Low Magnification of SEM Images of Worst-Case ESC (Environmental Stress Cracking)

Optim Insulation Biostability

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References
**SPC is an early-development name for Optim insulation.
† Pellethane is a trademark of Lubrizol Advanced Materials, Inc.
Society for Biomaterials 2004 Tan J, Jenney C. Effects of Polysiloxane Soft Segment Content on Biostability of Polyurethanes. 7th Biomaterials Congress, p 1876, Sydney, Australia, May 2004.
Karicherla A, Jenney C. Susceptibility of Elast-Eon 2A to Metal Ion Oxidation: Results of an Accelerated in vitro Study. 7th Biomaterials Congress, p 1878, Sydney, Australia, May 2004.
Jenney C, Karicherla A, Troutman T, Salerno A. In Vitro Evaluation of Elast-Eon 2A Susceptibility to Metal Ion Oxidation. 7th Biomaterials Congress, p 632, Sydney, Australia, May 2004.
Jenney C, Karicherla A, Troutman T, Salerno A. In Vivo Evaluation of Elast-Eon 2A Susceptibility to Environmental Stress Cracking. 7th Biomaterials Congress, p 1877, Sydney, Australia, May 2004. HRS 2005.
Jenney C, Tan J, Karicherla A, Burke J, Helland J. A New Insulation Material for Cardiac Leads with Potential for Improved Performance, HRS 2005, HeartRhythm, 2, S318-S319 (2005). Cardiostim 2006.
Tan J, Jenney C. In Vivo Biostability Study of A New Lead Insulation Material, Cardiostim 2006, Europace Supplements, 8, 179PW/9 (2006).
Note: Elast-Eon and SPC are early development names for Optim Insulation.
Tech Specs
Products Using Optim Insulation Model Numbers
RiataTM ST OptimTM Defibrillation Lead 7020, 7022, 7070, 7071, 7030, 7031
TendrilTM ST OptimTM Pacing Lead 1888TC, 1882TC
DurataTM True Bipolar, Active-Fixation Defibrillation Leads 7120, 7121, 7122

7120Q, 7121Q, 7122Q
DurataTM Integrated Bipolar, Active-Fixation Defibrillation Leads 7130, 7131
DurataTM True Bipolar, Passive-Fixation Defibrillation Leads 7170, 7171
IsoFlexTM OptimTM Passive-Fixation Leads 1944, 1948
Quartet™ Quadripolar LV Lead 1458Q
QuickFlex™ μ LV Lead 1258T
Indications, Safety & Warnings
Print

See the appropriate device for indications, contraindications, warnings, precautions and potential adverse events. Select Instructions For Use link for specific device indications:

  • DurataTM Defibrillation Lead
  • IsoFlexTM OptimTM Passive-Fixation Lead
  • TendrilTM ST OptimTM Pacing Lead
  • RiataTM ST OptimTM Defibrillation Lead
  • Quartet™ Quadripolar LV Lead 
  • QuickFlex™ μ LV Lead