CROSSING CHRONIC TOTAL OCCLUSIONS Safe, reliable, guaranteed treatment

Always Reaching Farther

Vascular Intervention

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CHRONIC TOTAL OCCLUSIONS: THE CROSSING CHALLENGE

Chronic Total Occlusions (CTOs) are a leading cause of amputation and the most

common reason patients are sent to surgery. Effective revascularization of CTOs

begins with successful crossing. However, this process can be complex and

frustrating. In fact, 20% to 30%1-4 of CTOs cannot be crossed with a guidewire

and support catheter alone. Having the right tools on hand to meet any crossing

challenge is essential to success. Spectranetics offers a complete portfolio

of products that enable you to safely and efficiently cross CTOs, and only

Spectranetics offers a written guarantee.

OUR WINNING SOLUTION FOR CROSSING CTOs

STEP 1

Wires

Traditional Crossing Wires • Turbo-Elite™ with 0.035” wire (ATK)

• Turbo-Elite™ with 0.014” wire (BTK)

88% SUCCESSafter failed

guidewire crossing5,6

97/100 CTOs Crossed

• Quick-Cross™

• Quick-Cross™ Extreme™

• Quick-Cross™ Select

80% SUCCESSStandard antegrade

recanalization1-4

80/100 CTOs Crossed

STEP 3

Step-by-Step

STEP 2

Catheters

94% SUCCESSafter failed antegrade

recanalization4,7-9

99/100 CTOs Crossed

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A Complete PortfolioSpectranetics’ portfolio of products includes support

catheters, lasers, and retrograde access products for

safely and reliably solving any CTO challenge.

Reliability Built InWhen used as part of the Spectranetics five-step

process for crossing and treating CTOs, our tools are

nearly 100 percent effective.

Safe. Period.The Spectranetics laser softens and vaporizes even the most

stubborn total occlusions into particles smaller than a red

blood cell, reducing the embolization risk. Support and laser

catheters help physicians stay true lumen from the start,

minimizing the risk of vessel damage. The Quick-Access™

Needle Holder and Quick-Cross Capture™ Guidewire Retriever

reduce radiation exposure during retrograde procedures.

GuaranteedOnly Spectranetics backs up its promises with a written

guarantee that you’ll never pay for a product that does

not cross a CTO. When you attempt to cross a CTO with

Spectranetics products from the start, you’ll only pay for

the product that is ultimately successful.

• Turbo-Elite™ with 0.035” wire (ATK)

• Turbo-Elite™ with 0.014” wire (BTK)

If you can cross ityou can treat it.

• Quick-Access™ Needle Holder

• Quick-Cross™ Capture™ Guidewire Retriever

STEP 5

Treat

STEP 4

Retrograde

A SOLUTION FOR EVERY CROSSING CHALLENGE

Spectranetics’ complete portfolio of products to cross and treat CTOs reliably and safely comes with a written guarantee of success.

Safe, effective vessel access during retrograde procedures:• Keeps hands away from peak radiation zone• Precise control over needle trajectory• Wire lock for preloading and anchoring of guidewire

The #1 selling support catheter:• Translucent shaft to confirm luminal access• Hydrophilic coating to allow for smooth passage

through CTOs• Low-profile tip hugs the wire to provide a low

crossing profile for challenging CTOs• Guidewire support to ensure CTO engagement and

to avoid collaterals

Designed for tougher lesions:• Stainless steel braid for increased pushability

in difficult CTOs• Hydrophilic coating to allow for smooth passage

through the CTO• Low-profile tip hugs the wire to provide a low

crossing profile for challenging CTOs

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The innovative, safe and versatile solution for crossing and treating CTOs above and below the knee:• Versatile performance• Cross and debulk with one device• Reliably simple• Strong clinical support

Designed for branched anatomy:• 45-degree angled tip to navigate difficult anatomy• Stainless steel braid for increased support and pushability• Hydrophilic coating to allow for smooth passage

through the CTO• Low-profile tip hugs the wire to provide a low crossing

profile for challenging CTOs

Easy, reliable and safe guidewire capture and exchange during retrograde procedures:• Funnel shape directs guidewire into lumen for quick

exchange• Low-pressure balloon automatically centers the device

within the vessel• Captures prolapsed or damaged wires• Helps shorten procedure time• Can be used in diseased vessels without dangers

inherent in manipulating a snare

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When a physician attempts to cross a CTO with Spectranetics products, they only pay for the product that is ultimately successful.

For more information, visit www.ctocrossing.com.

Always Reaching Farther

Corporate HeadquartersThe Spectranetics Corporation9965 Federal Dr., Colorado Springs, CO 80921Tel: 719-447-2000 • Fax: 719-447-2022 • Customer Service: 800-231-0978

German OfficeSpectranetics Deutschland GmbHSchweinfurter Str. 797080 Würzburg, Germany Phone: +49 931/4520080 • Fax: +49 931/45200811

Spectranetics International B.V.Plesmanstraat 6, 3833 LA LeusdenThe NetherlandsTel: +31 33 4347 050 • Fax: +31 33 4347 051

©2014 Spectranetics. All rights reserved. Approved for external distribution. D022730-00 042014

1 Complex_PA_Intervention_The_Role_of_New_CTO_devices.Laird.0707062 Lancet. 2005 Dec 3;366(9501):1925-343 Shishehbor, Submitted 2013, VIVA 20134 Rogers Rk, et al, Catheter Cardiovasc Interv.2011 May 1;77(6):915-25. doi: 10.1002/

ccd.22796. Epub 2011 Mar 85 H.J. Steinkamp, C. Wissgott, J. Rademaker, D. Scheinert, et al, Cardiovascualar and

Interventional Radiology 2002:25:388-3966 J. Laird, T. Zeller, B. Gray, D. Scheinert, et al, Limb Salvage Following Laser-Assisted

Angioplasty for Critical Limb Ischemia: Results of the LACI Multicenter Trial, J Endovasc Ther., Feb. 2006, Vol. 13, pg. 1-11.

7 Palena L., Manzi M., J Endovasc Ther 2012; 19:805-8118 Elias Noory, MD; Aljoscha Rastan, Thomas Zeller, MD, et al, J ENDOVASC THER

2009;16:619–6239 Fabrizio Fanelli, MD; Pierleone Lucatelli, MD, et al, J Endovasc Ther. 2011;18:503–509

Important Safety InformationISI QUICK CROSS:

Quick-Cross Indications Quick-Cross Support Catheters are guidewire exchange and infusion devices designed for use in the vascular system. The catheters are intended to support a guidewire during access of vasculature, allow for exchange of guidewires and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Contraindications None known.

Warnings Maximum infusion pressure is 300 psi. The catheter is designed and intended for intra-vascular use only. This catheter is designed and intended for one-time use only. Do not re-sterilize and/or reuse. Careful inspection before use should verify that the catheter has not been damaged in shipment and that its condition is suitable for the procedure. The catheter should not be advanced through an area of resistance unless the source of resistance is identified by fluoroscopy and appropriate steps are taken to reduce or remove the obstruction. Catheter manipulation should occur only under fluoroscopy. If the catheter is used for infusion, reference the table of flow rates and ensure infusion pressure does not exceed the recommendations. Avoid introducing air or any other gas through the catheter into the vascular system.

ISI QUICK CROSS CAPTURE

Indications for UseThe Quick-Cross Capture Guidewire Retriever is intended to be used in conjunction with a steerable guidewire to access discrete regions of the vasculature and for guide-wire exchange. The Quick-Cross Capture Guidewire Retriever is not intended for use in the coronary, cerebral or carotid vasculature.

Contraindications None.

Description The Quick-Cross Capture is a coaxial lumen design catheter with a balloon mounted on its distal tip. The outer lumen is for balloon inflation and is accessed through the side female luer at the proximal end of the Y-connector. The inner through lumen permits the use of guidewires to facilitate the advancement of the catheter through and around the stenosis. The wire lumen is accessed through the second port of the Y-connector. The Quick-Cross Capture Catheter is indicated for non-coronary and non-cerebral arteries (e.g., femoral, iliac, tibial, popliteal, and renal arteries).A removable balloon protector is provided. Two radiopaque bands identify the catheter.

WarningsThe devices are intended for one-time use only. Do not resterilize or reuse. Reuse and/or resterilization of the device will result in cross-patient blood contamination and compromised sterilization.

Do not advance the guidewire or the Quick-Cross Capture if resistance is met.

CAUTION: Pressure in excess of 5 ATM can cause balloon rupture.

CAUTION: Use an inflation device with a pressure gauge for balloon inflation/deflation.

Use only appropriate balloon inflation medium. Do not use air or gaseous medium to inflate the balloon.

ISI QUICK ACCESS

Indications for UseThe Quick-Access Needle Holders are intended to facilitate the placement of guidewires into the vascular system.

Contraindications None.

WarningsThe devices are intended for one-time use only. Do not resterilize or reuse. Reuse and/or resterilization of the device will result in cross-patient blood contamination and compromised sterilization.

Do not advance the guidewire or the Quick-Access Needle Holder if resistance is met.

Use only appropriate guidewires of size 0.035” and below.

TURBO-ELITE LASER ATHERECTOMY CATHETERThe Turbo-Elite Laser Catheter is indicated for use in the treatment, including atherec-tomy, of infrainguinal stenoses and occlusions.

Note:  Successful step-by-step passage of guidewires does not necessarily ensure relief of critical limb ischemia.  Additional procedures may be required

Rare but serious potential adverse events include: the need for urgent additional procedures or surgery due to bleeding, vascular damage, loss of blood flow or other complications; decrease or loss of kidney function due to contrast exposure; the need for amputation due to inability to restore blood flow; and infection, stroke, irregular heartbeat, heart attack or death.

This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure to you.

ContraindicationsNo known contraindications.

WarningsFederal (USA) law restricts this device to sale by or on the order of a physician with appropriate training.

SPECTRANETICS’ TURBO ELITE® LASER ATHERECTOMY CATHETERS CVX-300® EXCIMER LASER SOFTWARE REQUIREMENTS:

Software V3.8XX V3.7XX

Catheter Maximum Rep Rate80 Hz40 Hz

When the laser catheter is in the body, it should be manipulated only while it is under fluoroscopic observation with radiographic equipment that provides high quality images.