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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.