AZUR™ Peripheral Hydrocoil Embolization System

AZUR Peripheral HydroCoil Embolization System

PRODUCT OVERVIEW

SUPERIOR FILLING VOLUME AND PACKING DENSITY


AZUR Peripheral Hydrocoil has superior mechanical stability2-5 and offers the potential to use less coils which may provide cost saving per procedure.5

SUPERIOR FILLING VOLUME AND PACKING DENSITY COMPARED TO BARE PLATINUM COILS4

The AZUR Peripheral HydroCoil Embolization System combines a platinum coil and an expandable hydrogel polymer. In concert, these elements provide a uniquely stable and permanent platform for blood stasis, thrombus organization, and neointima formation.1, 2, 3

AZUR’s hydrogel coating undergoes limited expansion within the first 3 minutes, and fully expands within 20 minutes*. The result is greater filling and mechanical stability with fewer coils – nearly 5 times more filling volume for the 0.018" coil and 4 times more filling volume for the .035" coil (versus platinum coils of the same size). In other words, AZUR works harder so you don’t have to.

IN-SERVICE VIDEO

AZUR Detachable HydroCoil Inservice Guide (Video)

AZUR Pushable HydroCoil Inservice Guide (Video)

PRODUCT CODES DETACHABLE

AZUR HydroCoil Detachable .018"

Product Code Description 1/BX
45-480202 AZUR 18D System 2mm x 2cm
45-480204 AZUR 18D System 2mm x 4cm
45-480302 AZUR 18D System 3mm x 2cm
45-480305 AZUR 18D System 3mm x 5cm
45-480310 AZUR 18D System 3mm x 10cm
45-480405 AZUR 18D System 4mm x 5cm
45-480410 AZUR 18D System 4mm x 10cm
45-480415 AZUR 18D System 4mm x 15cm
45-480420 AZUR 18D System 4mm x 20cm
45-480505 AZUR 18D System 5mm x 5cm
45-480510 AZUR 18D System 5mm x 10cm
45-480515 AZUR 18D System 5mm x 15cm
45-480520 AZUR 18D System 5mm x 20cm
45-480610 AZUR 18D System 6mm x 10cm
45-480615 AZUR 18D System 6mm x 15cm
45-480620 AZUR 18D System 6mm x 20cm
45-480810 AZUR 18D System 8mm x 10cm
45-480815 AZUR 18D System 8mm x 15cm
45-480820 AZUR 18D System 8mm x 20cm
45-481010 AZUR 18D System 10mm x 10cm
45-481015 AZUR 18D System 10mm x 15cm
45-481020 AZUR 18D System 10mm x 20cm
45-481215 AZUR 18D System 12mm x 15cm
45-481220 AZUR 18D System 12mm x 20cm
45-481515 AZUR 18D System 15mm x 15cm
45-481520 AZUR 18D System 15mm x 20cm
45-481530 AZUR 18D System 15mm x 30cm
45-482020 AZUR 18D System 20mm x 20cm
45-482030 AZUR 18D System 20mm x 30cm

PRODUCT CODES PUSHABLE

AZUR HydroCoil Detachable .035"

Product Code Description 1/BX
45-450405 AZUR 35D System 4mm x 5cm
45-450410 AZUR 35D System 4mm x 10cm
45-450415 AZUR 35D System 4mm x 15cm
45-450610 AZUR 35D System 6mm x 10cm
45-450615 AZUR 35D System 6mm x 15cm
45-450620 AZUR 35D System 6mm x 20cm
45-450815 AZUR 35D System 8mm x 15cm
45-450820 AZUR 35D System 8mm x 20cm
45-451015 AZUR 35D System 10mm x 15cm
45-451020 AZUR 35D System 10mm x 20cm
45-451215 AZUR 35D System 12mm x 15cm
45-451220 AZUR 35D System 12mm x 20cm
45-451230 AZUR 35D System 12mm x 30cm
45-451520 AZUR 35D System 15mm x 20cm
45-451530 AZUR 35D System 15mm x 30cm
45-452020 AZUR 35D System 20mm x 20cm
45-452030 AZUR 35D System 20mm x 30cm

AZUR HydroCoil Pushable .018"

Product Code Description 3/BX 
45-280202 AZUR 18P System 2mm x 2cm
45-280302 AZUR 18P System 3mm x 2cm
45-280304 AZUR 18P System 3mm x 4cm
45-280402 AZUR 18P System 4mm x 2cm
45-280404 AZUR 18P System 4mm x 4cm
45-280406 AZUR 18P System 4mm x 6cm
45-280504 AZUR 18P System 5mm x 4cm
45-280506 AZUR 18P System 5mm x 6cm
45-280510 AZUR 18P System 5mm x 10cm
45-280514 AZUR 18P System 5mm x 14cm
45-280606 AZUR 18P System 6mm x 6cm
45-280610 AZUR 18P System 6mm x 10cm
45-280614 AZUR 18P System 6mm x 14cm
45-280620 AZUR 18P System 6mm x 20cm
45-280810 AZUR 18P System 8mm x 10cm
45-280814 AZUR 18P System 8mm x 14cm
45-280820 AZUR 18P System 8mm x 20cm
45-281014 AZUR 18P System 10mm x 14cm
45-281020 AZUR 18P System 10mm x 20cm

AZUR HydroCoil Pushable .035"

Product Code Description 3/BX 
45-250404 AZUR 35P System 4mm x 4cm
45-250406 AZUR 35P System 4mm x 6cm
45-250506 AZUR 35P System 5mm x 6cm
45-250510 AZUR 35P System 5mm x 10cm
45-250610 AZUR 35P System 6mm x 10cm
45-250614 AZUR 35P System 6mm x 14cm
45-250810 AZUR 35P System 8mm x 10cm
45-250814 AZUR 35P System 8mm x 14cm
45-250820 AZUR 35P System 8mm x 20cm
45-251014 AZUR 35P System 10mm x 14cm
45-251020 AZUR 35P System 10mm x 20cm
45-251514 AZUR 35P System 15mm x 14cm
45-251520 AZUR 35P System 15mm x 20cm
45-251620 AZUR 35P System 16mm x 20cm

PRODUCT CODES CONTROLLER

Detachment Controller for use with Detachable Systems

Product Code Description - Pack of 5
45-4001 AZUR Detachment Controller

DOCUMENTS

AZUR Volume Advantage Sales Aid
AZUR Family Brochure
Embolization Pocket Guide
AZUR Pushable HydroCoil In-service Guide
AZUR Detachable HydroCoil In-service Guide
AZUR Hydrocoil Detachable IFU
AZUR Hydrocoil Pushable IFU

REFERENCES

RX ONLY. Refer to the product labels and package insert for complete warnings, precautions, potential complications, and instructions for use.

  1. Plenk H, Killer M, Richling B. Pathophysiologic considerations on HydroCoil- and platinum coil-occluded retrieved human cerebral aneurysms. Presented at ASITN MicroVention Symposium. 2005. (in-vivo study)
  2. Ding YH, Dai D, Lewis DA, Cloft HJ, Kallmes DF. Angiographic and histologic analysis of experimental aneurysms embolized with platinum coils, Matrix, and HydroCoil. AJNR Am J Neuroradiol. 2005 Aug;26(7):1757-63. (animal study)
  3. Sluzewski M, van Rooij WJ, Slob MJ, Bescós JO, Slump CH, Wijnalda D. Relation between aneurysm volume, packing, and compaction in 145 cerebral aneurysms treated with coils. Radiology. 2004;231(3):653-658.
  4. www.Angiocalc.com
  5. Data on file, 2014.

*Instructions For Use PD110088 Rev. B Revised 2012-11 and PD110090 Rev. A Revised 2012-11.