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The pre-market design process generates projected failure rates. Our lead modeling is independently validated1.
Occurs for all products through Returned Product Analysis (RPA). Leads aren’t typically returned and therefore quality issues may be underreported with passive surveillance alone.
Prospective product monitoring through the Product Surveillance Registry (PSR), which is an active multicenter clinical study
Cable design secures the tip assembly all the way to the connector and provides greater lead strength, which may aid in the lead extraction.4-7
The coil electrode connected at both ends facilitates more uniform energy distribution, adds mechanical integrity, and stabilizes coil during extraction.3
Wilkoff BL, Donnellan E, Himes A, et al. In vitro modeling accurately predicts cardiac lead fracture at 10 years. Heart Rhythm. September 2021;18(9):1605-1612.
Medtronic data on file. August 7, 1997; August 7, 2006; August 2007;April 9, 2012; August 3, 2012.
Cuvillier E – Handbook of leads for pacing, defibrillation & cardiac resynchronization, Fourth Edition, 2021May 2022.
Medtronic data on file. October 17, 2008.
Medtronic data on file. October 4, 2000.
Smith MC, Love CJ. Extraction of Transvenous Pacing and ICD Leads. Pacing Clin Electrophysiol. June 2008;31(6):736-752.
Wilkoff BL, Al-Khadra AS. The Technique of Transvenous Lead Extraction. Nonpharmachological Therapy of Arrhythmias for the 21st Century: The State of the Art. Futura Publishing Co, Inc., Armonk, NY, 1998.
Medtronic Product Performance Report, May 2022 https://wwwp.medtronic.com/productperformance/past-reports.html
See the device manual for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. If using an MRI SureScan™ device, see the MRI SureScan™ technical manual before performing an MRI. For further information, contact your local Medtronic representative and/or consult the Medtronic website at www.medtronic.eu (opens new window).
For applicable products, consult instructions for use on manuals.medtronic.com. Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser.