MKW01Z128 Package Information Ordering Information Device Device
ORDERING INFORMATION - Surefire Medical, Inc. · To order product or for more information, ......
Transcript of ORDERING INFORMATION - Surefire Medical, Inc. · To order product or for more information, ......
To order product or for more information, contact Customer Service at 888.321.5212 or fax to +1.303.426.1223
© 2015 Surefire Medical, Inc. All rights reserved.
6272 W. 91st Avenue • Westminster, CO 80031 • 888.321.5212 TOLL-FREE • +1.303.426.1222 OFFICE • +1.303.426.1223 FAX • www.surefiremedical.com
MKT-SRF-0001-R07
ORDERING INFORMATION
Surefire Infusion SystemsCatalog Number Description
SHF-38120-mT Surefire Infusion System mT
SHF-38120-LT Surefire Infusion System LT
Intended Use: The Surefire Infusion System is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.
Contraindications: The Surefire Infusion System is not intended for use in the central nervous system or central circulatory system.
Product Specifications Useable Length Outer Diameter Inner Diameter Recommended Vessel Size
SHF-38120-mT 120 cm 3.8F 0.027” 2mm - 4mm
SHF-38120-LT 120 cm 3.8F 0.027” 4mm - 6mm
Prior to use, please see the complete ‘Instructions for Use’ for the product’s Indications, Contraindications, Warnings, Precautions,
Adverse Events, and Operator’s Instructions at www.surefiremedical.com or in the insert provided with the product.
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This drawing is the confidential property of Surefire Medical Inc.Neither it nor the information it contains may be reproduced,disclosed, or given to any third party without expressed written permission from Surefire Medical Inc.
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FOR RELEASE STICKER ONLY
The Surefire Infusion System
>> WE DELIVER.
Designed to Minimize RefluxThe Surefire expandable tip is designed to expand in reverse flow, which is essential in reducing reflux of diagnostic and therapeutic agents to non-target vessels and minimizing potential damage to healthy tissue.
Go with the FlowSurefire’s unique expandable tip is designed to dynamically collapse in forward flow and expand to the vessel wall in reverse flow. The Surefire Infusion System LT allows 84.4% of endogenous forward blood flow even in worst case conditions (2.7mm vessel and flow rates less than 60 mL/min).4
Animal Study ResultsIn animal studies, the Surefire Infusion System was compared to a standard microcatheter in
embolization efficiency, also known as targeted delivery. The Surefire Infusion System achieved
targeted delivery of 99.9% compared to 72% for a standard microcatheter (p<0.05).3
4 Data on file at Surefire Medical, Inc. 5 Courtesy of Daniel Sze, MD, PhD at Stanford Medical Center, Palo Alto, California.
Case StudyClinical Diagnosis: HCC
Anatomy: Mildly hypervascular focal lesion in segment 2/3 requiring Infusion System placement on
a curve in a second order branch of the Left Hepatic Artery (LHA).
Treatment Plan: The Surefire Infusion System was advanced into a second order branch of the LHA
which infused segments 2 and 3, then the Surefire expandable tip was deployed. Tumor was only
mildly hypervascular by angiography, DynaCT, and CT. Doxorubicin-eluting spheres, 100-300 micron
diameter, suspended in two-thirds iohexol 300 were administered until near-stasis. Despite only
subtle hypervascularity, the tumor retained iodinated contrast given with the DEBs. At the three
week follow-up after the procedure, alpha-fetoprotein (AFP) level dropped from 3468 to 345 ng/mL
(90% decrease).5
Standard microcatheter fails to achieve full coverage due to embolic agents
re-routing to non-target zones.
With the Surefire Infusion System, 99.9% of the embolic agent is delivered to the target zone.
The Surefire® Infusion SystemTargeted DeliveryThe suite of Surefire Infusion Systems is designed to deliver therapy with higher embolization efficiency1 than a standard microcatheter, allowing physicians to maximize targeted delivery during infusion procedures. In a recent retrospective study of 29 patients, the Surefire Infusion System showed no angiographic evidence of reflux and no clinical evidence of non-target embolization. Additionally, in chemoembolization patients, CT imaging suggested a pattern of increased microsphere tumor penetration and contrast retention.2
.
REFERENCES: 1 Embolization efficiency is defined as the percentage of infusate that is delivered to the target vessel.
2 J. D. Louie, E. A. Wang, S. Broadwell, B. C. Wible, A. Arepally, C. Nutting, L. Bester, D. Y. Sze. First in Man Experience with the Surefire Infusion System – A dedicated microcatheter system to eliminate reflux during embolotherapy. Presented during Society of Interventional Radiology Annual Scientific Meeting, March 2012.
3 A. Arepally, J. Chomas, D. Kraitchman, and K. Hong. Quantification and Reduction of Reflux during Embolotherapy Using an Antireflux Catheter and Tantalum Microspheres: Ex Vivo Analysis. JVIR, 2013.
>> DELIVERS THE DOSE.
>> INCREASES INFUSION CONTROL.
>> REDUCES REFLUX.
Targeted Delivery
100%
80%
60%
40%
20%
0%Standard
MicrocatheterSurefireInfusionSystem
Sub-selective Left Hepatic Artery Infusion
The Surefire expandable tip is located at the target location in a second order branch of the LHA. Angiography showed only subtle enhancement of the tumor.
Full Dose Administered
The tumor exhibited significant staining (arrows) by retained iodinated contrast. No reflux was observed during infusion.
Standard Microcatheter
SUREFIRE MEDICAL IS CREATING A NEW CLASS OF INFUSION SYSTEMS.