Alert Indications, Safety, and Warnings

ConcertoTM Helix and 3D Detachable Coil Systems for peripheral embolization

The Concerto™ Helix and 3D Detachable Coil Systems offer helical and complex options for peripheral embolization, in diameters from 2 to 20 mm.

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Alert Indications, Safety, and Warnings

Overview

ConcertoTM coils controlled delivery animation

Watch the ConcertoTM Detachable Coil Systems in action.

Indications

The ConcertoTM  Detachable Coil System is indicated for arterial and venous embolizations in the peripheral vasculature.

Product details

Treat more patients

  • Treat multiple anatomies with the combination of complex and helical coils.
  • Smoothly reach distal and challenging vessels thanks to the coil softness.1

Treat them safely

  • The detachment system has a 99.7% success rate.1
  • The microcatheter kickback is minimal with a soft distal pusher and 360° rotation of ball-and-socket design.1

Treat them faster

Fibers reduce the occlusion time, enhancing the mechanical action of bare coils.2

  • 80% increase in peak thrombin production.*2
  • 241% higher rate of thrombin.*2
Concerto detachment system close-up with a blue arrow going around the center
Circle statistic stating 80% increase in peak thrombin production
Circle statistic stating a 241% higher rate of thrombin

* Compared to bare coils. Percentages are calculated from the average of PGLA and nylon fibered coils.

Showcase

This interactive collection of cases for peripheral embolization solutions allows you to browse through the anatomy and review real case studies from experienced physicians. Get started and see the Concerto™ Coils in action.

Start the Experience
Human anatomy peripheral vasculature with navy blue squares over certain areas

Manuals and technical guides

The technical manuals include indications, warnings, precautions, MRI information, and directions for use. Find them in the product labeling supplied with each device, or by calling 1-763-526-7890. 

MRI Information

Non-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 (Excite, Software G3.0- 052B, General Electric Healthcare, Milwaukee, WI).

Model specifications

ConcertoTM Helix Detachable Coil System

Soft coil with helical shape for packing

Concerto Helix detachable coil system shown inside the peripheral vasculature

ConcertoTM 3D Detachable Coil System

Conformable and stable coil with complex shape for framing

Concerto 3D detachable coil system shown inside an aneurysm
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References

1

Test data on file at Medtronic with internal reports TR13-067 rev B / TR13-081 Rev A / TR12-054 REV A / TR14-061 Rev A / TR14-062 Rev A / TR14-065 Rev A. Bench test results may not be indicative of clinical performance.

2

Girdhar G, Read M, Sohn J, Shah C, Shrivastava S. In-vitro thrombogenicity assessment of polymer filament modified and native platinum embolic coils. J Neurol Sci. April 15, 2014;339(1-2):97-101.