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Indications, safety, and warnings Concerto Helix and 3D detachable coil systems

Note: Safety information provided is for the United States. Please refer to your region’s Instructions for Use for specific details.

Reference Statement

Important Information: Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: The Concerto™ detachable coil system is indicated for arterial and venous embolizations in the peripheral vasculature. Results may vary. Not all patients achieve the same results.

Caution: Federal (USA) law restricts these devices to sale, distribution, and use 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.

Potential Complications

Potential complications include, but are not limited to:

  • Puncture site hematoma
  • Thromboembolic episodes
  • Vessel perforation
  • Neurological deficits including stroke and death
  • Vasospasms
  • Vascular thrombosis
  • Hemorrhage
  • Ischemia

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