NV-3-8-HELIX

Concerto™ Helix and 3D detachable coil systems

Indications, Safety, and WarningsMRI Safety InformationIndications (or Intended Use)The Concerto™ detachable coil system is indicated for arterial and venous embolizations in the peripheral vasculature.ContraindicationsThere are no known contraindications.Potential Adverse Events (or Potential Complications)The potential complications include, but are not limited to, the following: puncture site hematoma, thromboembolic episodes, vessel perforation, neurological deficits including stroke and death, vasospasms, vascular thrombosis, hemorrhage, and ischemia.CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device, at www.medtronic.com/manuals, or contact a Medtronic representative.FTSOP113326-42c
UC202113743-01a ENMRI safety and compatibilityNon-clinical testing has demonstrated that Concerto™ Detachable Coils are MR Conditional. Concerto™ Detachable Coils can be scanned safely under the following conditions:

Static magnetic field of 3-Tesla or less

Spatial gradient field of 720 Gauss/cm or less

Maximum averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of scanning.

In non-clinical testing, Concerto™ Detachable Coils produced a temperature rise of less than 0.3°C at a maximum averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of MR scanning in a 3-Tesla MR scanner system.UC202504116 EN

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