AZUR

Expanding TERUMO Territory.

™

Watch this little coil

become the biggest thing

in peripheral embolization (It will only take a few minutes)

TERUMO INTERVENTIONAL SYSTEMS

The Technology of Expansion 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.

AZUR’s hydrogel coating expands by 80% within 3 minutes and by 100% 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 0.035" coil (versus platinum coils of the same size). In other words, AZUR works harder so you don’t have to.

Once expanded, the hydrogel remains soft and compliant. The hydrogel is an inert substance that:5,6

Does not contain or produce biologics

Is not associated with any known toxicity, in-vivo material hypersensitivity, or interaction with other embolic agents

Will not degrade or break down

AZUR’s unique overcoil (detachable system only) is designed to enhance trackability, deliverability, and repositioning ability.

The AZUR Peripheral HydroCoil Embolization System is not just a new product; it is the next generation of embolic coils.

Once you’ve tried it, you’ll agree that it renders all other coils obsolete.

TERUMO INTERVENTIONAL SYSTEMS

Expanding on Anything That’s Come Before The challenge of occluding vascular lesions calls for volume, safety, stability, and control.

The AZUR Peripheral HydroCoil Embolization System meets all of these requirements with unprecedented efficacy and efficiency.

Thanks to a unique hydrogel polymer coating that expands when introduced into the bloodstream, AZUR delivers superior mechanical occlusion and provides a scaffolding for stability through increased filling with fewer coils than previously required.1,2 The hydrogel polymer technology featured in the AZUR Peripheral HydroCoil Embolization System has been:

Demonstrated to lower vascular recurrence rates versus platinum and PGLA coils3,4

Validated through 5 years of global experience in the endovascular treatment of cerebral aneurysms and other peripheral vascular lesions such as GI bleeds, pulmonary AVMs, and trauma

Analyzed in more than 200 laboratory studies, 20 peer-reviewed published journal articles, and 100 oral and poster presentations

AZUR detachable coil in its unexpanded state

The bottom line is clear and compelling—AZUR will empower you to approach even the most challenging anatomies with new capability and confidence.

Endothelial formation. This image illustrates the growth of neointima at the neck of an aneurysm in a rabbit model.

Hydrogel facilitates this process.

Hydrogel

Artery lumen

Expanding in the direction of least resistance. As this image illustrates, hydrogel expands in the direction of the flow—not in the direction of the vessel below.

Hydrogel

Artery lumen

A Whole New Measure of Control Compared with conventional platinum or stainless steel coils, AZUR delivers superior performance across the board:

Superior volume filling, packing density, and occlusion efficacy1,2

Superior mechanical stability

Permanent mechanical occlusion without the need to wait for thrombus formation

Increased delivery control

Increased long-term durability

Enhanced reconstruction of the artery wall (versus platinum coils)7

No wonder AZUR’s hydrogel polymer technology has demonstrated lower recurrence rates versus both platinum and PGLA coils.3,8 Considering these proven advantages, there is no reason to use anything else.

AZUR detachable coil showing expansion of hydrogel polymer

Magnified image of unexpanded hydrogel showing porous structure.

Magnified image of expanded hydrogel.

Expanded porous hydrogel provides excellent substrate for healing (neointima formation, smooth muscle cell migration).4,9,10

Detachable or Pushable Two distinct options.

Same expanding technology.

The AZUR detachable system is the first product in the industry to offer detachment in less than a second at the push of a button. An LED confirms that the detachment mechanism has been activated.

Ideal for high-flow areas and challenging anatomies, the AZUR detachable system provides a whole new level of control.

Using the AZUR Detachment Controller, you detach the coil only when it is properly in place.

By empowering you to retract and reposition the coil until you are thoroughly satisfied with the placement, the detachable system minimizes the risk of coil migration.

The AZUR pushable system works like traditional pushable coils with the added advantage of greater filling volume.

Whichever option you choose, you’ll benefit from AZUR’s unique hydrogel polymer technology. Once the coil is in place, AZUR’s hydrogel coating safely expands in the direction(s) of least resistance— reducing leaks and maximizing mechanical occlusion, while decreasing the number of coils required.3,8,9,10

At the push of a button, the AZUR Detachment Controller detaches the coil in less than 1 second.

An LED confirms that the detachment mechanism has been activated.

Your complete occlusion tool kit.

With the choice of AZUR’s detachable and pushable systems, you can now achieve optimal efficiency and maximum occlusion in a wider range of procedures than ever before, using the fewest coils possible.

The AZUR detachable and pushable systems come in a wide range of sizes. (See pocket insert for sizes and ordering information.)

TERUMO INTERVENTIONAL SYSTEMS

TERUMO — A Global Leader in Medical Devices Terumo Introducers Pinnacle® Introducer Sheaths Pinnacle® Destination® Guiding Sheaths Pinnacle® R/O II Radiopaque Marker Introducer Sheaths Pinnacle® R/O II HiFlo Introducer Sheaths Glidesheath™ Introducer Sheaths Glidewire® Access Micro Accessing Systems GlideAccess™ Micro Accessing Systems Terumo Guidewires Glidewire® Hydrophilic Coated Guidewires Glidewire® GT Hydrophilic Coated Guidewires Glidewire® Gold Hydrophilic Coated Guidewires Runthrough™ NS Coronary Guidewire

Expanding TERUMO Territory.™

Terumo Angiographic Catheters Glidecath® Hydrophilic Coated Catheters Glidecath® XP Hydrophilic Coated Catheters Terumo Microcatheters Progreat™ Hydrophilic Coated Microcatheters Progreat™ Coaxial Microcatheter Systems Terumo Radial Compression Devices TR Band™ Radial Compression Devices Terumo Interventional Products AZUR™ Peripheral HydroCoil® Embolization System Bead Block™ Compressible Microspheres Terumo Accessories Torque Device Obturators

References: 1. 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. 2. Cloft HJ, Kallmes DF. Aneurysm packing with HydroCoil Embolic System versus platinum coils: initial clinical experience. AJNR Am J Neuroradiol. 2004;25(1):60-62.

3. DURABLE Multi-center HES Registry (Albany Medical Center, Beaumont Regional Medical Center, Loyola University Medical Center) of 260 aneurysms with 186 follow-ups treated with HydroCoil.

Presented at ABC/WIN. 2006. 4. Plenk H, Killer M, Richling B. Pathophysiologic considerations on HydroCoil- and platinum coil-occluded retrieved human cerebral aneurysms. Presented at ASITN MicroVention Symposium. 2005. 5. Fujiwara NH, Kallmes DF. Healing response in elastase-induced rabbit aneurysms after embolization with a new platinum coil system. AJNR Am J Neuroradiol.

2002;23(7):1137-1144. 6. Kallmes DF, Fujiwara NH. New expandable hydrogel-platinum coil hybrid device for aneurysm embolization. AJNR Am J Neuroradiol. 2002;23(9):1580-1588. 7. Bavinzski G, Talazoglu V, Killer M, et al. Gross and microscopic histopathological findings in aneurysms of the human brain treated with Guglielmi detachable coils. J Neurosurg. 1999;91(2):284-293. 8. HEAL Registry. MicroVention, Inc. (197 aneurysms; 128 follow-up cases; mean follow-up of 14 months). 9. Virmani R. Healing and inflammation in experimental and clinical aneurysms. Presented at WFITN. 2005. 10. 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;26(7):1757-1763.

For more information, call 800.862.4143 to speak to an Inside Sales Customer Care Representative, or visit www.terumois.com Terumo Interventional Systems 2101 Cottontail Lane Somerset, NJ 08873 Fax: 800.411.5870 ©2007 Terumo Medical Corporation. All rights reserved. All brand names are trademarks or registered trademarks of Terumo. HydroCoil is a registered trademark of MicroVention Inc. Bead Block is a trademark of Biocompatibles UK Ltd. TIS110 12/07

TERUMO INTERVENTIONAL SYSTEMS