Optim™ Insulation

This device is commercially available for use in the United States and select international markets.

A New Material For a New Generation Of Cardiac Leads

Durata Defibrillation Lead with 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.

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-Pass™ 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.

Improved Flexibility

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

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.

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)

**SPC is an early-development name for Optim insulation.

Products Using Optim Insulation Model Numbers
Riata™ ST Optim™ Defibrillation Lead 7020, 7022, 7070, 7071, 7030, 7031
Tendril™ ST Optim™ Pacing Lead 1888TC, 1882TC
Durata™ True Bipolar, Active-Fixation Defibrillation Leads

7120, 7121, 7122

7120Q, 7121Q, 7122Q

Durata™ Integrated Bipolar, Active-Fixation Defibrillation Leads 7130, 7131 
Durata™ True Bipolar, Passive-Fixation Defibrillation Leads

7170, 7171 

7170Q, 7171Q, 7172Q

IsoFlex™ Optim™ Passive-Fixation Leads 1944, 1948 

Low Magnification of SEM Images of Worst-Case ESC (Environmental Stress Cracking) Bench Testing Results

 

References

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.

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