ClearWay™ Peripheral Solutions - Atrium Medical Corporation
ClearWay™ Peripheral Solutions - Atrium Medical Corporation
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>.