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ABLATIONYOU CAN COUNT ON

The Emprint™Ablation System with Thermosphere™ Technology

Technology overview

1 Thermosphere™ Technology Overview

EMPRINT™ABLATION SYSTEMWITH THERMOSPHERE™ TECHNOLOGY

▪ 100 W generator with an intuitive user interface and customizable power settings for simplified set-up and operation

▪ 15 cm, 20 cm, and 30 cm antenna lengths

When it comes to procedure results, achieving sufficient ablative margin is a top predictor of local tumor control1

Tumor

Margin

FOR PATIENTS, MARGIN MATTERS


PREDICTABILITY IS THE PROBLEM

Historically, manufacturer ex vivo liver ablation recommendations have not accurately predicted clinical results2,3

Ablation Margins

Radiofrequency

Microwave

Expected Achieved


PREDICTABILITY CHALLENGES ARE OVERCOMEBY CONTROLLING ACTIVE HEATING

All thermal ablation devices affect tissue by means of two distinct heating zones –called the active and passive zones

Controlling the active heating zone and minimizing reliance on the passive zone to grow ablation volume increases predictability.

▪ Active heating occurs where the tissue isabsorbing intense electrical energy deliveredfrom the ablation probe.

▪ Passive heating is transfer of heat by thermal conduction or thermal convection into tissues surrounding the ablation probe.

▪ An ablation zone results where the combination of active and passive heatingexceed thermally toxic tissue temperaturesfor a sufficient period of time.


MICROWAVE TECHNOLOGY HAS EVOLVED

Over time, microwave technology has evolved, gradually delivering better control of the active heating zone

With next generation Thermosphere™ technology, repeatable, spherical results have arrived.4

NO CONTROLS THERMAL AND FIELD CONTROLS WAVELENGTH CONTROL



Thermal Control

As the ablation starts elements in the antenna begin to conduct heat. Thermosphere™ technology has thermal control with advanced antenna cooling. This prevents heat from traveling up the antenna shaft and contributing to the ablation zone.

Field Control

Thermosphere™ technology has advanced antenna geometry that focuses energy at the tip of the device into a precise spherical electromagnetic field.

Wavelength Control

As the tissue properties change over time, Thermosphere™ technology uses wavelength control to prevent the microwaves from elongating down the antenna shaft.

THE FIRST AND ONLY TECHNOLOGYWITH THREE TYPES OF CONTROL

ONLY THERMOSPHERE™TECHNOLOGYHAS WAVELENGTH CONTROL

Variable Active Heating Without Wavelength Control Conventional Microwave.

Stable Active Heating With Wavelength Control Thermosphere™Technology.

Wavelength control is unique to next generation microwave ablation technology

It minimizes microwave energy elongation on the radiator. This allows for field control to effectively create a robust and stable spherical electromagnetic field across a range of tissue types.4

DESSICATED TISSUE

LIVER

KIDNEYLUNG

DESSICATED TISSUE

LIVER

KIDNEYLUNG


ADVANCED ANTENNA DESIGNENABLES WAVELENGTH CONTROL

Ceramic

Cooling fluid

Polymer plastic

Metal

Fiberglass

Composite

Conventional Microwave Technology

Time zero Time zero

1 minute

5 minutes

5 minutes

Conventional Technology with CeramicLoading Dielectric

Thermosphere™

Technology

1 minute

Time zero

1 minute

5 minutes


SO YOU CAN PLAN AND PLACE WITH CONFIDENCE

Conventional Microwave

Probe trajectory planning with elliptical ablations

Thermosphere™Technology

Probe trajectory planning with spherical ablations

Approach option 1

Approach option 1

Approach option 2

Approach option 2


AND ACHIEVE TRULY PREDICTABLE OUTCOMESWITH A SINGLE PROBE

Thermosphere™ Technology

100 W, 5 min5

Single Antenna

3.3 cm

±0.5

Conventional Microwave Technology

65 W, 5 min1

Two Antenna Three Antenna

3.3 cm

±0.68

2.27 cm

±0.79

Maximum inscribed diameter was defined as the maximum circle diameter that fits inside the ablation zone, which is more indicative ofthe area that could be treated with the ablation than minimum or maximum diameter.1


THE DIFFERENCE IS CLINICALLY PROVEN

Ierardi AM et al.Updates in Surgery

Berber E et al.Surgical Endoscopy

Hoffman T et al.WCIO2015

Howk K et al.WCIO2015

Berber E et al.HPB

Zaidi N et al.Journal ofSurgical Oncology

Chetboun M et al.Journal of Surgical Oncology

Park J et al.WCIO2016

Venkat S et al.CIRSE2016

Takahashi H et al.SSO2017

De Cobelli F et al.Medical Onoclogy

Clinical Article –Liver

Clinical Abstract

Pre-clinicalAbstract

Letter to Editor

20162015 2017


REFERENCES

1. Harari CM, Magagna M, Bedoya M, et al. Microwave ablation: Comparison of simultaneous and sequential activation ofmultiple antennas in liver model systems. Radiology. 2015;2:142-151. Data selected from Table 1. Ablation Zone Size,Shape, and Temperature Metrics (In vivo data in porcine liver model using Certus 140 with PR15 antennas, n = 7).

2. Winokur RS, Du JY, Pua BB, et al. Characterization of in vivo ablation zones following percutaneous microwave ablation of the liver with two commercially available devices: Are manufacturer published reference values useful? J Vasc Interv Radiol. 2014;25(12):1939-1946.e1.

3. Tarantino L. Percutaneous ablation of small hepatocellular carcinoma: Comparison of 3 commercially available microwave devices. J Vasc Interv Radiol. 2013; 24(5):759.e1-759.e40.

4. Howk K. Consistent and predictable spherical ablation shape in both liver and lung: Performance of the Emprint™ ablation system with Thermosphere™ technology in an in vivo porcine model [Poster 129]. J Vasc Interv Radiol. 2015; 26:e33-3103.

5. Based on internal test report R0043973_B, in vivo performance testing of the Emprint™ MWA system in a porcine model (porcine liver model, n = 8).

6. Ierardi AM, Mangano A, Floridi C, et al. A new system of microwave ablation at 2450 MHz: Preliminary experience. Updates Surg.2015;67(1):39-45.

7. Berber E. Laparoscopic microwave thermosphere ablation of malignant liver tumors: An initial clinical evaluation. Surg Endosc. 2016;30:692.

8. Hoffman T, Kalia A, McLennan G, et al. Can planning software be used to confirm complete thermal coverage during percutaneous microwave ablations? [Poster 29]. J Vasc Interv Radiol. 2015;26:e33-3103.

9. Chetboun M, Kianmanesh R, Sommacale D, Diebold MD, Piardi T. Complete necrosis after microwave thermosphere ablation of liver metastases from colorectal cancer, histological proof of efficacy. J Surg Oncol. 2016;113(7):843-4.

Thermosphere™ Technology Overview12

10. Berber E. The first clinical application of planning software for laparoscopic microwave thermosphere ablation of malignant liver tumors. HPB. 2015;17(7):632-6.doi: 10.1111/hpb.12423.

11. Zaidi N, Okoh A, Yigitbas H, et al. Laparoscopic microwave thermosphere ablation of malignant liver tumors: An analysis of 53 cases. J Surg Oncol. 2016;113(2):130-134.

12. Park J, Kessler J, Lee A. Early safety and effectiveness of thermosphere microwave ablation (Emprint™) in the percutaneous treatment of perivascular liver tumors [Poster 142]. J Vasc Interv Radiol. 2016;27:e47–e114.

13. Jonhson DT, Dodd GD. Characterization of a microwave ablation device characteristics in a perfused liver model. J Vasc Interv Radiol. 2016;27:e47–e114.

14. Venkat S, Froud T, Salas N, et al. Accuracy evaluation of microwave ablation with the Covidien Emprint™system in hepatocellular carcinoma: do expected volumes correlate with in vivo results. Cardiovasc Intervent Radiol. 2016;39(3):35-386.

15. Takahashi H, Pournik H, Berber E. Local recurrence after laparoscopic microwave Thermosphere™ablation of malignant liver tumors [PF221]. Ann Surg Oncol. 2017;24:S1–S192.

16. De Cobelli F, Marra P, Ratti F, et al. Microwave ablation of liver malignancies: Comparison of effects and early outcomes of percutaneous and intraoperative approaches with different liver conditions. Med Oncol. 2017;34:49.

DISCLAIMER: Animal data is not necessarily indicative of human clinical outcomes.

Thermosphere™ Technology Overview13

REFERENCES

The Emprint™Ablation System with Thermosphere™ Technology

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PREDICTABILITYFOR YOU.OPTIONS FOR YOUR PATIENTS.

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