Optim® Insulation

Position with the Best

Optim insulation—the first silicone-polyurethane co-polymer insulation created specifically for cardiac lead use—combines the flexibility and biostability of silicone with the lubricity and durability of polyurethane.

Optim Insulation 

Features & Benefits

Innovative Insulation

A new material for a new generation of products: After 12 years of focused study, St. Jude Medical has introduced Optim lead insulation - proven to be dramatically more flexible, lubricious and abrasion-resistant than current insulations.

Improved Handling

  • Improved lubricity: In bench testing, Optim insulation with Fast-Pass® coating showed less frictional value than silicone or polyurethane. This test shows that a lead with Optim insulation potentially provides a smoother implant—especially with multiple leads in one vein—than a silicone or polyurethane lead.
  • Improved flexibility: In bench testing, Optim lead tip stiffness was considerably less stiff than 55D polyurethane (Pellethane) and similar to silicone rubber.

Increased Durability

  • Improved abrasion-resistance: In bench testing, Optim insulation with Fast-Pass® coating was more resistant to abrasion in lead-on-lead contact testing than silicone rubber.
  • Proven biostability: After two years of implantation, Optim insulation has shown biostability at least as good as 55D polyurethane (Pellethane).

1 Jenney C, Tan J, Karicherla A, Burke J, Helland J. A new insulation material for cardiac leads with potential for improved performance, HRS 2005, Heart Rhythm, 2, S318-S319 (2005).

2 SPC is an early development name for Optim insulation.

Clinical Information

Safety & Indications

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Please see the physician’s manual for appropriate devices for indications, contraindications, warnings, precautions and potential adverse events.

Product Comparison

Reimbursement Information

Related Materials

 Optim Lead Insulation - Physician Presentation

 

Published Clinical Articles

After 12 years of design and testing, the following clinical articles featuring Optim insulation have been published:

  • Society for Biomaterials 2004 Tan J, Jenney CR. Effects of Polysiloxane Soft Segment Content on Biostability of Polyurethanes. 7th Biomaterials Congress, p 1876, Sydney, Australia, May 2004.
  • Karicherla A, Jenney CR. 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.

Product Components

Demonstration Video

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