Durata

Minimizes Lead Abrasion

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

Clinical Intel: Excellent Long-Term Performance of Abbott ICD Leads Reinforced by ESC Presentation⁵

• This multi-center prospective study evaluated long-term performance of Durata ICD leads
• A total of 11,132 patients were followed over a period of 11 years – reflecting three prospective registries (beginning in 2006)
• Potential instances of lead failure were adjudicated by an electrophysiologist: There were ZERO reported instances of externalized conductors in the study
  • The all-cause mechanical failure rate (0.29%/yr.) reported in this study exceeds industry benchmarks
  • Furthermore, the data also includes returned products and non-returns, resulting in an incidence rate that is a true reflection of real-world performance
• This study builds on the earlier publications from HRS, and reinforces our excellent record of long-term ICD lead survival

References

1. Forleo GB, Di Biase L, Panattoni G, et al. Systematic fluoroscopic and electrical assessment of implantable cardioverter-defibrillator patients implanted with silicone-polyurethane copolymer (Optim™) coated leads. EP Europace. 2014;16(2):265-270. doi.10.1093/europace/eut236.
2. Heart Rhythm Society. Electrical survival analysis of St. Jude Medical Durata and Riata ST Optim high-voltage leads from the VA National Cardiac Surveillance Program. 2016. https://www.abstractsonline.com/pp8/#!/3934/presentation/14474. Accessed November 6, 2018.
3. Kramer DB, et al. Transvenous Implantable Cardioverter-Defibrillator Lead Reliability. Journal of the American Heart Association. 2015;4e001672. doi 10.1161/JAHA.114.001672.
4. Abbott. Product Performance Report. 2020. 1st edition. SJM-ELP-90624466 REV A.
5. Cairns J, Balasubramanian K, Ellison T, Epstein A, Healey J, Connolly S. Low rates of mechanical failures of silicone-polyurethane copolymer- coated ICD leads: 11 years prospective follow-up. Presented at ESC 2019.