Neuwave Brochure Spreads V15 PL 000223 Rev A System Product

: Pdf Pl-000223 Rev A Neuwave System Product Brochure PL-000223_Rev_A_Neuwave_System_Product_Brochure 1 2016 pdf

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Versale probe porolio for tailored

treatments with 1, 2 or 3 probes

Synchronized energy delivery for

consistent mul-probe ablaons

CO2 cooling for the smallest

gauge probe and Tissu-Loc™

to reduce probe migraon

Ablaon Confirmaon™ to

show you if you got it all!

The NeuWave Medical® Intelligent Ablaon System was developed by physicians and microwave sciensts at the University of

Wisconsin who were looking for a beer soluon for paents with so ssue lesions.

DISCLAIMER: The Certus 140 2.45 GHz Ablaon System is a tool, not a treatment for any disease or condion. It is cleared for the ablaon (coagulaon) of so ssue in percutaneous, open surgical

and in conjuncon with laparoscopic surgical sengs in paents who present themselves to a treang physician with a wide variety of diseases or condions. The Certus 140 2.45 GHz Ablaon

System is not indicated for use in cardiac procedures. The system is designed for facility use and should only be used under the orders of a physician.

PROVEN SYSTEM DEVELOPED BY PHYSICIANS

NeuWave Medical is focused on meaningful clinical innovaon and product differenaon to drive beer paent outcomes and

lower costs. Our computer-controlled plaorm, developed with an open architecture enables all systems to be easily upgraded

with addional features and enhancements.

POSITIONED FOR THE FUTURE

For more informaon on the NeuWave Medical® Intelligent Ablaon System, contact us:

877-323-WAVE (9283)

info@NeuWave.com

NeuWave.com

Dedicated Clinical Specialists for case coverage

Comprehensive physician and staff training with a

formal competency evaluaon and cerficaon

NeuWave Medical didacc and in-vivo animal

training labs

SUPPORTED BY TRAINING AND EDUCATION

Regional case observaon and hands-on learning labs

Peer-to-peer collaboraon for case review with key

thought-leaders

Reimbursement hotline: 800-400-7651

(c) NeuWave Medical 2015

PL-000233 REV A 8/15

MICROWAVE LEADS ABLATION MARKET GROWTH

ABLATION PROCEDURE GROWTH 2013 - 2023

The U.S. ablaon market is growing rapidly due to the rising interest in minimally invasive opons. Microwave ablaon is

currently the fastest growing modality in the ablaon market, and will largely replace radiofrequency as the preferred ablaon

choice in the future.1Microwave ablaon is a minimally invasive outpaent

procedure that uses electromagnec waves to generate so

ssue necrosis in the lung, liver and kidney.

35000

30000

25000

20000

15000

10000

500

0

“The use of microwave ablaon will increase

substanally in the liver and lung indicaons

through 2023...Some companies, such as

NeuWave Medical, provide devices that are

specifically designed to effecvely ablate

ssue in delicate, aerated lung ssue.”

Radiofrequency Ablaon

-4.1%

CAGR 2013 - 2023

Cryoablaon

5.9%

Microwave Ablaon

14.8%

- Millennium Research Group 2015 1

MICROWAVE ABLATION

TO SURGE IN THE U.S.

The growth of microwave ablaon

connues to surge in the U.S. due to the

limitaons imposed by the alternave RF

ablaon technology.1

1. Intervenonal Oncology Devices / US/ 2015 Market Analysis Millennium Research Group, August 2014

Using CT or Ultrasound imaging, a small probe is

inserted percutaneously into lesion.

Electromagnec waves are delivered to the ssue,

producing friconal heang to generate ssue

necrosis at >60°C.

Ablaon Confirmaon™ soware, only from

Neuwave Medical®, is used to assess the technical

success of the ablaon procedure.

HOW MICROWAVE

ABLATION WORKS

BENEFITS OF

MICROWAVE ABLATION*

Supported by mulple Clinical Pracce Guidelines.

Strong efficacy and low complicaon rate versus

other common treatment modalies.1

Most procedures completed with 5-10 minutes of

ablaon me.

Many paents leave the hospital the same day2 as

the procedure with only a bandage at the probe

inseron point.

1

2

3

* All medical procedures carry potenal risks that should be discussed with paents prior to any microwave ablaon procedure. See the Certus 140 User Manual for a full list of warnings and cauons.

1. T. Ziemlewicz, et al, Percutaneous Microwave Ablaon of Hepatocellular Carcinoma with Gas-Cooled System: Inial Clinical Results with 107 Tumors. Journal of Vascular Intervenonal Radiology 2015;

26: 62–68. A. Moreland, et al, High-Powered Microwave Ablaon of T1a Renal Cell Carcinoma: Safety and Inial Clinical Evaluaon. Journal Of Endourology Sept. 2014; Volume 28, Number 9. B.T.

March, et al, Microwave ablaon for lung neoplasms: a retrospecve analysis of long term results. Journal of Vascular and Intervenonal Radiology 2014, Volume 25, Issue 3 , S97.

2. J. Horn, et al, Percutaneous Microwave Ablaon of Renal Tumors Using a Gas-Cooled 2.4-GHz Probe: Technique and Inial Results. Journal of Vascular Intervenonal Radiology 2014; 25: 448 – 453

Precision™ PR

probe inserted

into lesion

“From a paent’s perspecve, this procedure is really wonderful because it’s very

precise and the aermath impacts are negligible. I didn’t have any discomfort, I

was up the next day feeling fine and I was back in the classroom the day aer.”

- Kevin McSweeny, paent**

COMPUTER CONTROLLED SYSTEM DELIVERING HIGH

POWERED, FAST ABLATIONS

Touchscreen interface

Procedure data stored and

easily accessible

Daily call home system for

performance monitoring

Independent power and me control

on each channel during procedure

Highest power output = faster

ablaon (195W)

THE NEUWAVE MEDICAL® INTELLIGENT ABLATION SYSTEM

CO2 COOLED SYSTEM FOR THE SMALLEST GAUGE PROBE

AND TISSU-LOC™ TO REDUCE PROBE MIGRATION

17 gauge probe =

Less invasive procedures

Reduces probe migraon

Tissu-Loc™ technology “scks" the

probe in place, minimizing probe

migraon during imaging and

addional probe placement

NeuWave Medical®

17g

Compeon

13g

When it comes to ablang lesions, achieving the best outcomes for each individual paent is paramount. The totality of the

NeuWave Medical Intelligent Ablaon System allows you to tailor treatments to each paents’ clinical need and offers the only

integrated in-procedure confirmaon of your ablaon.

VERSATILE PROBE PORTFOLIO WITH MULTI-PROBE SYNCHRONY

FOR TAILORED TREATMENTS WITH 1, 2 OR 3 PROBES

PRECISION™ PR PROBE

≤ 4 cm single probe ablaons in any so ssue1

The only probe available with limited ablaon

length to limit necrosis of adjacent ssue,

including crical structures

For ≤ 4 cm, single probe ssue sparing ablaons1

1. Bovine liver ex-vivo: 65W, 5 minutes = 4.14 cm x 2.64 cm, 65W, 10 minutes = 4.65 cm x 3.06 cm, Bovine kidney ex-vivo: 65W, 5 minutes = 3.28 cm x 2.30 cm, 65W, 10 minutes = 3.82 cm x 2.60 cm,

Bovine lung ex-vivo: 65W, 5 minutes = 2.80 cm x 1.74 cm, 65W, 10 minutes = 4.08 cm x 3.22 cm

2. Bovine liver ex-vivo: 140W , 5 minutes = 6.0 cm x 3.7cm, 140W , 10 minutes = 7.0 cm x 4.0 cm, Bovine kidney ex-vivo: 140W , 5 minutes = 4.4 cm x 2.5 cm, 140W , 10 minutes = 6.4 cm x 3.4 cm, Bovine

lung ex-vivo: 140W , 5 minutes = 6.0 cm x 3.3 cm, 140W , 10 minutes = 6.0 cm x 3.9 cm

3. Laeseke et al. Mulple-Antenna Microwave Ablaon: Spaally Distribung Power Improves Thermal Profiles and Reduces Invasiveness. Journal of Intervenonal Oncology. 2009; 2(2):105-112. Brace et

al. Simultaneous Acvaon of Mulple Microwave Antennas Improves Circularity and Ablaon Zone Volume Compared to Sequenally Overlapping Ablaons. Presented at conference with

accompanying poster, WCIO 2014.

Rounder ablaons with no cleing

Mulple synchronized probes create larger and more

spherical ablaon zones than a single reposioned probe3

4

MAX™ LK AND LN PROBES

Tissue-tuned for large, single probe ablaons2

MAX LK single probe ablaons2

≤ 7 cm = liver, ≤ 6 cm = kidney

MAX LN single probe ablaon2

≤ 6 cm = lung

6

7,6

COMPETITION: 1 probe reposioned 3 mes

NEUWAVE MEDICAL®: 3 synchronized probes

10 min burn

5 min burn

2 min burn

1 cm eming point

PR PROBE BURN PATTERN: Tip-weighted probe with eming point 1 cm

from p. Ablaon encompasses p and then burns proximally (away).

2 cm eming point

10 min burn

5 min burn

2 min burn

LK & LN PROBE BURN PATTERNS: Ablaon progresses uniformly both

distally and proximally from the eming point 2 cm from p.

Increased confidence in covering target with

less reliance on precise probe placement

Consistent, predictable ablaons as waves

work in synchrony

MULTI-PROBE SYNCHRONY

ABLATION CONFIRMATION™ OFFERING THE ONLY INTEGRATED

IN-PROCEDURE CONFIRMATION TO SHOW YOU IF YOU GOT IT ALL!

Ablaon Confirmaon (AC) is a CT image processing soware that resides on a second, dedicated monitor aached to the NeuWave

Medical Intelligent Ablaon System. AC takes the uncertainty out of procedures by assisng physicians in idenfying ablaon probe

placement and confirming ablaon zones without having to leave the procedure room.

Pre-procedure and post-procedure scans registered

(overlaid) into one image to confirm technical success

of procedure.

Pre-procedure and post-procedure scans are on separate

monitors. Physician must "imagine" scans overlaid in aempt

to confirm technical success of procedure.

WITHOUT

ABLATION CONFIRMATION

WITH

ABLATION CONFIRMATION

BENEFITS OF ABLATION CONFIRMATION

ABLATION CONFIRMATION™ IN 3 EASY STEPS

Pull set-up CT scan into

soware

Segment lesion

Define margin

DEFINE YOUR TARGET

1

Place probes, perform

CT scan and pull scan

into soware

Register scans to assess

probe placement in

relaonship to

idenfied target

Available Views:

2D, 3D, Periscope

and Needle

PLACE PROBES AND VERIFY

2

Perform ablaon, take

post-procedure CT scan

and pull scan into soware

Segment ablaon zone

Register ablaon scans

to assess and/or confirm

technical success of

procedure

Available Views:

2D, 3D

ABLATE AND CONFIRM

3

Probe missed lesion

Segmented lesion and margin defined

Probe placed in lesion

Ablaon doesn’t cover lesion and margin Ablaon covers lesion and margin

Confident Probe Placement

See the exact proximity of the probe to the

lesion so you can ablate with greater confidence

Confirm Complete Ablaon

Verify technical success of the procedure

by viewing combined target and ablaon

zone scans

Collaborate with Colleagues Remotely

Remote access allows colleagues to support

ablaon cases in real-me

Demonstrate Your Success

Clear 2D and 3D procedure images are

stored to PACS and can be shared among

paents, referrers and peers to showcase

your procedure success

Target Ablaon Zone Pre-Procedure Scan Post-Procedure Scan

2D View

Periscope and Needle View

3D View