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Clinical Evidence

Clinical Evidence

PROVEN RELIABILITY AND PERFORMANCE FOR OPTIM

The Optim™ Insulation Lead Technology Clinical Compendium shares long-term survival rates reported from multiple independent and prospective registries confirming the strength of high-voltage ICD leads with Optim insulation in clinical use.*

99.1% FREEDOM

FROM ALL-CAUSE MECHANICAL FAILURE.¹
Line graph showing event free survival rates for all-cause insulation abrasion in Optim ICD leads from 0 to 9 years.

96.1% FREEDOM

FROM ALL-CAUSE MECHANICAL FAILURE.¹

Data on 11,083 Optim leads from three actively monitored prospective registry studies with 9 years follow-up.

Calculated by Population Health Research 0.90 Institute (PHRI), an independent third party.

Line graph showing event free survival rates for all-cause mechanical failure in Optim ICD leads from 0 to 9 years.

>99% 5-YEAR SURVIVAL PROBABILITY

FOR ICD LEADS WITH OPTIM LEAD INSULATION.²

Data on over 4,400 ICD leads with Optim lead insualtion with up to 7 years of follow-up from the VA National Cardiac Device Surveillance Program, based on independent analysis of national device registry data from over 120 VA medical facilities.

Presented at HRS 2016 by Dr. Seema Pursnani.

Line graph showing Durata and Riata ST Optim lead survival analysis from 0 to 7 years.

References

*Clinical Data for Optim Lead Insulation was gathered in studies using ICD leads. Abbott uses Optim Lead Insulation as an insulator for both High Voltage and Low Voltage leads

  1. Abbott Implantable Electronic Systems Product Performance Report, 2017 First Edition. (2017). Retrieved from https://professional.sjm.com/professional/resources/product-performance/product-performance-reports/current.
  2. Pursnani, S. (2016). Electrical survival analysis of St. Jude Medical Durata and Riata ST Optim high-voltage leads from the VA National Cardiac Device Surveillance Program [abstract]. Presented at Heart Rhythm 2016. San Francisco, California.
Indications, Safety & Warnings

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