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ClearWay™ Peripheral Solutions - Atrium Medical Corporation

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ClearWay <br />

<strong>Peripheral</strong> <strong>Solutions</strong><br />

The Thrombus<br />

Management Company


Advanced Treatment Strategy for<br />

Thrombus Management & Slow Flow<br />

Effective Clinical Applications<br />

• Iliac/SFA<br />

• Popliteal<br />

• Tibial<br />

• Pulmonary Embolism<br />

• DVT<br />

• AV De-clot


Thrombus<br />

Management Solution<br />

The presence of thrombus is associated with 1 :<br />

• Higher rates of complications including amputation and death<br />

• Higher re-occlusion rates<br />

• Higher emergent revascularizations<br />

• Prolonged hospitalization and procedure times<br />

• Increase in thrombo-embolic events<br />

Thrombus burden<br />

present in vessel<br />

ClearWay balloon controllably<br />

engages vessel wall to occlude<br />

blood flow during local drug<br />

infusion, increasing drug availability<br />

Thrombus dissolution achieved<br />

from local drug delivery to<br />

the treatment zone


<strong>Peripheral</strong> Thrombus Solution<br />

SFA<br />

SFA Thrombotic Lesion<br />

Result After 5mg of tPA Administered<br />

x 2 via ClearWay RX 3.0 x 20mm<br />

Final Result After<br />

Self-Expanding Stent<br />

Placed<br />

Popliteal<br />

Total Occlusion of<br />

Popliteal Artery<br />

Abciximab* Infusion via<br />

ClearWay RX<br />

Flow Re-Established<br />

in Popliteal Artery<br />

Tibial<br />

Total Occlusion of<br />

Posterior Tibial Artery<br />

Result After Atherectomy<br />

and PTA of the SFA.<br />

Total Occlusion of the<br />

Anterior Tibial Artery.<br />

Final Result After<br />

Eptifibatide** Infused<br />

via ClearWay RX.<br />

Flow Restored to<br />

Tibial Vessels.<br />

World’s Most


AV De-clot<br />

Thrombosed<br />

AV Graft<br />

tPA infused via<br />

ClearWay OT W<br />

6mm x 50mm<br />

Restoration of<br />

flow with stenosis<br />

now visible<br />

Final angiogram<br />

following PTA<br />

of stenosis<br />

Effective Drug Infusion Balloon for Treating


Life Saving Applications<br />

Pulmonary Embolism (DVT)<br />

Thrombus Present Throughout<br />

Pulmonary Artery with<br />

No Perfusion to the Right Lung<br />

ClearWay RX 4.0 x 50mm Delivered<br />

Site Specific Boluses of tPA to Multiple<br />

Pulmonary Branches<br />

Resolution of Thrombus with Excellent<br />

Perfusion to the Right Lung<br />

30 day CT Image with<br />

Restored Flow to the Lungs<br />

Thrombus and Slow Flow Conditions


Proven Clinical Performance<br />

Supportive Clinical Literature for Thrombus Management Utilizing ClearWay Local Drug Infusion Catheter<br />

Treatment of Complex Thrombotic Popliteal Chronic Total Occlusion using Pathway PV Jetstream or Laser<br />

Atherectomy, and Localized Delivery of Acbiximab via ClearWay RX Catheter. Dave R. Cath Lab Digest, January 2009.<br />

Successful Revascularization of Re-stenosis of Lower Extremity Arteries with Localized Delivery of Paclitaxel.<br />

Latif et al. Catheterization and Cardiovascular Interventions, 2008. Volume 72. Pages 294-298.<br />

Use of Simultaneous Angioplasty and in Situ Thrombolysis with a Specialized Balloon Catheter for <strong>Peripheral</strong><br />

Interventions. Rathi et al. Journal of Thrombus & Thrombolysis, 2009.<br />

A Novel Technique for the Treatment of Life Threatening Pulmonary Embolus. Edwards P, Goodman J.<br />

Presented at ISET 2011. In press.<br />

New ClearWay OTW Device-Marketing Evaluation Results<br />

• Used in a wide variety of arterial and venous peripheral applications<br />

• Demonstrated good deliverability and performance<br />

• Provided a better outcome after failed treatment options in several cases<br />

• Saved time<br />

• Avoided overnight IV therapy<br />

• Complete thrombus resolution<br />

“ClearWay proved to be fast and effective<br />

for the treatment of peripheral thrombus”


www.atriummed.com<br />

ClearWay Ordering Information<br />

Rapid<br />

Local Therapeutic Infusion Catheter<br />

Exchange .014"<br />

Balloon Diameter Balloon Length* Catheter Length Guidewire Size Code #<br />

1.0 mm 10 mm 134 cm .014" 80200<br />

1.0 mm 20 mm 134 cm .014" 80202<br />

1.5 mm 20 mm 134 cm .014" 80208<br />

2.0 mm 20 mm 134 cm .014" 80214<br />

2.5 mm 20 mm 134 cm .014" 80220<br />

3.0 mm 20 mm 134 cm .014" 80232<br />

3.5 mm 20 mm 134 cm .014" 80244<br />

4.0 mm 20 mm 134 cm .014" 80250<br />

2.0 mm 50 mm 134 cm .014" 80217<br />

3.0 mm 50 mm 134 cm .014" 80235<br />

4.0 mm 50 mm 134 cm .014" 80253<br />

Over<br />

Local Therapeutic Infusion Catheter<br />

the Wire .035"<br />

Balloon Diameter Balloon Length* Catheter Length Guidewire Size Code #<br />

4.0 mm 10 mm 80 cm .035" 85851<br />

5.0 mm 10 mm 80 cm .035" 85853<br />

6.0 mm 10 mm 40 cm .035" 85854<br />

6.0 mm 10 mm 80 cm .035" 85855<br />

7.0 mm 10 mm 40 cm .035" 85856<br />

7.0 mm 10 mm 80 cm .035" 85857<br />

8.0 mm 10 mm 40 cm .035" 85858<br />

8.0 mm 10 mm 80 cm .035" 85859<br />

5.0 mm 50 mm 90 cm .035" 85912<br />

5.0 mm 50 mm 140 cm .035" 85913<br />

6.0 mm 50 mm 90 cm .035" 85914<br />

6.0 mm 50 mm 140 cm .035" 85915<br />

To place an order or request product information, call <strong>Atrium</strong> Customer Service or your local sales professional.<br />

Federal (USA) law restricts this device to sale by or on the order of a physician.<br />

1. An Overview of Pharmacotherapy During Percutaneous <strong>Peripheral</strong> Interventions of Thrombotic Lesions.<br />

Shammas N. Vascular Disease Management. March/April 2007<br />

*Abciximab is not indicated for IC delivery<br />

**Eptifibatide is not indicated for IA delivery<br />

ATRIUM MEDICAL CORPORATION ATRIUM EUROPE B.V. ATRIUM AUSTRALIA-PACIFIC RIM PTY. LTD.<br />

5 Wentworth Drive Rendementsweg 20 B Level 6, 579 Harris Street<br />

Hudson, New Hampshire 03051 U.S.A. 3641 SL Mijdrecht, The Netherlands Ultimo NSW 2007 Australia<br />

603-880-1433 603-880-6718 +31 297 230 420 +31 297 282 653 +61 2 8272 3100 +61 2 8272 3199<br />

© <strong>Atrium</strong> <strong>Medical</strong> <strong>Corporation</strong> 2011. All rights reserved. Printed in U.S.A. 01/11 Part #0329. <strong>Atrium</strong> and ClearWay are trademarks of <strong>Atrium</strong> <strong>Medical</strong> <strong>Corporation</strong>.

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