The Forleo, et al. single-site study was the first systematic fluoroscopic and electrical assessment of Optim™ insulation coated leads (n=413 overall: 225 high voltage, 188 low voltage).
An analysis of more than 4,400 leads with Optim™ lead insulation with up to seven years of follow-up from the VA National Cardiac Device Surveillance Program2 shows:
Data on 445 Durata and Riata ST Optim leads from an independent review of 2,653 patients implanted with contemporary ICD leads at four United States clinical centers after a median of 3.2 years of follow-up.3
|Number of leads at risk each year after implant.|
|St. Jude Medical Durata and Riata™ ST Optim™||445||417||362||262||156||80||31||2|
|Medtronic Sprint Quattro Secure‡||1821||1737||1545||1177||838||500||232||42||8|
|Boston Scientific Endotak Endurance‡ / Endotak Reliance‡||389||365||331||257||194||132||79||31||15|
The Durata lead uses Optim lead insulation, which is supported by evidence from approximately 11,130 leads actively monitored in prospective registries, more than 40,000 patient years of data and multiple third-party publications.4 Postmarket surveillance of these leads demonstrated that there were ZERO reported instances of externalized conductors in the study.5