truFreeze® Liquid Nitrogen Spray Cryotherapy

Only

From Barrett's Esophagus to Cancer

Now with the Rapid AV™ Catheter

What Powers Your Ablation - Only truFreeze

Effective Ablation with Liquid Nitrogen and the Rapid AV™ Catheter

Examples of Benign and Malignant Applications

ECM is Cryo-Resistant due to low water content, but breaks down with heat

Intact ECM enables healing within days with limited scarring or fibrosis2

The non-contact nature of truFreeze spray cryotherapy enables ablation of benign

and malignant tissue of various shapes, nodularities, and sizes allowing for complete coverage of the ablative areas in even the most

difficult anatomical locations.

By taking advantage of liquid nitrogen's unique cryogenic properties, truFreeze is the only device indicated to ablate Barrett's Esophagus with high grade dysplasia and/or low grade dysplasia and also to ablate malignancies, such as esophageal cancers.

- Hemostasis - Stricture management - Stent overgrowth/ingrowth - Radiation proctitis

- Dysphagia - GAVE - Diseases of the high cardia

-196oC flash freeze, re-warm to body temperature causes instant cell death

The New Rapid AV Catheter Makes Ablation Faster and Easier

The Rapid AV Catheter:

- Stainless steel material decreases time to LN2

- Quick LN2 decreases overall ablation time

Ablates Barrett’s Esophagus with high grade dysplasia

and/or low grade dysplasia

The Power ofLiquid Nitrogen

Ablates Cancers

of the esophagus such as Adeno/squamous cell carcinoma1

-20oC Benign

cell death

-50oC Malignant cell death

Frozen Cells

Preserved Extracellular

Matrix

Cell Repopulation

What Powers Your Ablation - Only truFreeze

- Neil R. Sharma, M.D. President, Parkview Cancer Institute; Director, Advanced Interventional Endoscopy & Endoscopic Oncology; Medical Director, GI Oncology Program; Volunteer Assistant Professor – Indiana University

Not All Ablations are Equal... truFreeze - The Clear Choice in the Continuum of Care for your Patients

"We see a clear reduction in post-procedural pain and increased toleration with truFreeze in our large patient population as compared to other modalities of ablation for Barrett’s esophagus and cancer, which allows us to improve the patient experience."

In several peer-reviewed studies, truFreeze was shown to be well-tolerated with a low pain and side-effect profile6, 7, 8

Esophagus Histology: Anticipated depth of injury based on ablation temperature profiles.

*Vertical scale expanded to aid in visualization

• LN2 (blue line) Benign cell kill is 1 mm deep over 2 cm2 area.

• N2O (green line) Benign cell kill is 0.5 mm deep over 0.4 cm2 area.

• RFA (red line) Benign cell kill is 0.7 mm deep over full area.

LN2 Malignant cell kill is 1 mm deep over 2 cm2 area.

**N2O and RFA: Not capable of malignant cell kill.

Epithelium

Lamina Propria

Muscularis Mucosae

Submucosa

Expected Ablation Depth5

0cm 1cm 2cm

Dep

th (

mm

)*

Length (mm)

LN2 at (-196oC)3

Temperature profile after 20 second paint application

-10 -8 -6 -4 -2 0 2 4 6 8

0.25

1.0

2.0

3.0

-50

-20

0

Benign cell kill

Malignant cell kill

RFA4

Simulated Temperature profile of tissue after direct application

Dep

th (

mm

)*

Length (mm)

0.25

1.0

2.0

3.0

Benign cell kill

-10 -8 -6 -4 -2 0 2 4 6 8 10

+50

Dep

th (

mm

)*

Length (mm)

N2O at (-80oC)3

Temperature profile after 14 second dwell application

0.25

1.0

2.0

3.0

-200

Benign cell kill

-10 -8 -6 -4 -2 0 2 4 6 8

20

10

0

-10

-20

-30

-40

-50

-60

-70

20

10

0

-10

-20

-30

-40

-50

-60

-70

70

60

50

40

30

20

10

20

10

0

-10

-20

-30

-40

-50

-60

-70

10 10

0.25

1.0

2.0

3.0 Dep

th (

mm

)*

Length (mm)

0

-70

-8 -6 -4 -2 0 2 4 6 8-10 10

-50

-20

LN2 at (-196oC)3

Temperature profile after 30 second paint application

+50

Benign Disease

Malignant Disease**

Patient Tolerability

Length 213 cm

Outer Diameter 2.1 mm

Minimum Endoscope Working Channel 2.4 mm

MaterialsBiocompatible and latex-free stainless steel hypotube with a polymer coating

truFreeze® System Spray Cryotherapy Console

CC301

• Console• Fill kit

truFreeze® System Rapid AV Spray Catheter Kit 2000177

• Straight Spray Catheter• Catheter introducer• 20 Fr CryoDecompression Tube (CDT)• Connector and suction tubing

Active Venting Cryo Decompression Tube

ACCCC3CDT05

• 20 Fr CDT

Indications for Use

The truFreeze System is intended for cryogenic destruction of tissue using liquid nitrogen spray that has

a boiling point of -196°C, requiring either active or passive venting during surgical procedures.

The truFreeze System is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology,

and general surgery to ablate benign (e.g., Barrett’s esophagus with high grade dysplasia and/or low

grade dysplasia) and malignant lesions.

References1. Tsai et. al., “Safety and efficacy of endoscopic spray cryotherapy for esophageal cancer.” Disease of the Esophagus

2017; Vol. 30 Issue 112. Yiu, et. al., "Cryosurgery: A Review." Int J Angiol 2007; Vol. 16, pp 1-63. Based upon internal test fixture data using tissue mimetic. 4. Based upon internal simulations.5. Shaheen et. al., "ACG Clinical Guideline: Diagnosis and Management of Barrett’s Esophagus." Am J Gastroenterol

2016; 111:30–506. Greenwald et. al., “Endoscopic spray cryotherapy for esophageal cancer; safety and efficacy.” GIE 2010; 71: 86-937. Greenwald et. al., “Safety, tolerability, and efficacy of endoscopic low-pressure liquid nitrogen spray cryotherapy in the

esophagus.” Diseases of the Esophagus 2009; Vol. 23, pp. 1-78. Shaheen et al., “Safety and efficacy of endoscopy spray cryotherapy for Barrett’s esophagus with high-grade

dysplasia.” GIE 2010; 71:680-859. Based upon internal sales data

761750 Rev. A

Liquid Nitrogen Spray Cryotherapy Delivered through the truFreeze® System

Over 30,000 liquid nitrogen spray

cryotherapy procedures performed to date!9

STERIS 5960 Heisley RoadMentor, OH 44060-1834 – USA

Customer Service: +1 800-548-4873Fax: 440-639-4495

www.steris.com

©2020 STERIS Endoscopy or its affiliates. All rights reserved.Unless otherwise indicated, all marks denoted with ® or ™ are registered with the U.S. Patent and Trademark Office, or are trademarks owned by STERIS or its affiliates.

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