THE LEADING EDGE IN CRYOABLATION - Sanovamedicalsystems.sanova.at/download/kryoablation/Visual_ICE_MRI.pdf · Percutaneous MR-guided cryoablation of prostate cancer: initial-experience.

THE LEADING EDGE IN CRYOABLATION

BREAKING BOUNDARIES WITH ICE

ioablation.com btg-io.com

The new BTG Visual-ICE™ MRI Cryoablation System, developed with Galil™ Technology, is the only ablation system that leverages the unique advantage of cryoablation zone visibility with the exquisite image resolution of MR.

The Visual-ICE™ MRI Cryoablation System was designed for interventional Oncologists treating patients with compromised tissue* or other tissue characteristics that may benefit from enhancedMR visualisation.

SPECIALISED FOR THE MAGNET ROOM• The compact Mobile Connection Panel is placed within the MR room

- Sixteen needles may be simultaneously connected, allowing a range of cryoablation procedures

- Placement next to the scanner bed allows easy access to both the patient and the needles during a procedure

- Special features (STOP button, Channel 8 Needle Test button) facilitate magnet room controls.

CUSTOM DESIGNED FOR EACH INSTALLATION• Each design accommodates customer and site requirements

• Integrated into MR rooms with minimal installation and minimal downtime

CONSOLIDATED LINES FACILITATE CONNECTIONS• The Junction Box Harness organises gas, fibre optic, and electrical lines into a single cable

• Eight gas lines terminate into a single connection hub

• Connectors are easily aligned and securely clicked into position

INTRODUCING THE VISUAL-ICE™ MRI CRYOABLATION SYSTEM THELEADING EDGE IN CRYOABLATION

*previously irradiated or having had prior surgical intervention

Mobile Connection Panel



SPECIALISED FOR THE MR SUITE

5

4

3

2

1 MOBILE CONNECTION PANEL

JUNCTION BOX HARNESS

JUNCTION BOXES

PENETRATION PANEL

CONSOLE

5

4

3

21

BTG Visual-ICE™ M

RI Cryoablation SystemBTG Visual-ICE™

MRI Cryoablation System

INTUITIVE USER INTERFACE PROVIDES EASY OPERATION

LARGE HD TOUCHSCREEN CONTROLS SYSTEM OPERATION ANDDISPLAYS PROCEDURE STATUS

• Buttons provide easy cryoablation control

• Colour-coded bars visually display ongoing procedural summary offreeze, thaw and idle segments

• Enlarged, positionable timers allow monitoring of the procedurestatus from a distance

• Enlarged timers display elapsed cycle time and, when freezing,freeze intensity

• Optional cycle programming offers automation of frequently usedfreeze-thaw protocols

Procedure Screen

Cycle Sequence Programming

CRYOABLATION UNDER MR IMAGING OFFERS ACONTROLED AND PREDICATABLE ABLATION ZONE

SYSTEM FEATURES CONTROL ICEBALL SHAPE AND GROWTH

• Adjustable freeze intensity regulates ice growth

- Provides control near critical structures

- Stick mode secures a needle during placement of additional needles

• Eight separate system channels allow independent control per channel

• Activation of multiple needles provides opportunities to treat large tumours and to conduct multiple simultaneous treatments

• Different needle types can be combined to create optimal iceball shapes and sizes Adjustable Freeze Intensities



BTG Visual-ICE™ M



PROGRESSIVE CRYOABLATION PLATFORMSYSTEM SOFTWARE STREAMLINES OPERATION

• Gas indicators display real-time estimates of remaining gas time to minimise procedure interruption

• Online predictive diagnostics allow advance planning for maintenance

• Remote connectivity provides online software updates and downloads

MRI VISUALISATION ALLOWS MONITORING OF ICEBALL INFORMATION• Data was collected in room temperature gel; in-vivo dimensions are typically smaller than the dimensions generated in room temperature laboratory conditions

NEEDLES FOR MR CRYOABLATION PROCEDURES• IceSeedTM 1.5 MRI Cryoablation Needles

• IceRodTM 1.5 MRI Cryoablation Needles

Gas Indicators Display

1001020304050

00C-200C-400C

IceRodTM 1.5 MRI00C 42mm x 61mm | -200C 28mm x 49mm | -400C 17mm x 42mm

IceSeedTM 1.5 MRI00C 37mm x 43mm | -200C 23mm x 32mm | -400C 14mm x 23mm

Millim

eters

This data was collected at 210C (room temperature)

BTG Visual-ICE™ M



MRI CRYOABLATION COUPLES SUPERB TISSUE DEFINITION WITH EFFECTIVE ABLATION• Superior contrast between normal and frozen

tissue1,3-5 and high contrast of structures

surrounding the ablation zone6-7

• Multi-planar images of iceball growth2,3,8

and superior spatial resolution of

critical structures9

• Multi-dimensional depiction of the iceball in

relation to the target tumour12

• No ionizing radiation2,8,14

• Simultaneous imaging in sagittal and coronal

planes facilitate precise needle placement2,4,8,15

• Cryoablation can be performed under 1.5-T

and 3-T imaging, in open and closed bore

MR environments2,8,15,16

Axial Renal MRI Image Courtesy of Kemal Tuncali,

MD, Department of Radiology, Brigham and Women’s

Hospital, Boston, MA

Axial Prostate MRI Image Courtesy of Kemal Tuncali,



Coronal Prostate MRI Image Courtesy of Kemal Tuncali,



Coronal Renal MRI Image Courtesy of Kemal Tuncali,





About MRI Cryoablation


CRYOABLATION PERFORMED UNDER MRI IMAGING PROVIDES EXCELLENT PATIENT BENEFIT OUTCOMES

Excellentsafety and efficacy

profiles2,11,18

Local tumourcontrol following asingle treatment2,8,22

No ionizingradiation2,8,14

Optionfor patients with

previously irradiatedtissue and surgically

compromisedtissue3,9,10

Minimallyinvasive treatmentoption with short

hospital stay2,8,19, lowmorbidity and rapid

recovery18

Optionfor conscious

sedation with localanaesthesia5,14,15,17 as

cryoablation producesan analgesic

effect7

Repeatability17




CRYOABLATION UNDER MR GUIDANCE EFFECTIVELY TREATS A RANGE OF APPLICATIONS, INCLUDING• KIDNEY:Cryoablation is a well-established and accepted therapy for T1a renal masses2,8

- Cryoablation preserves renal function2,20

- Bilateral and multiple tumours can be safely ablated during a single session15,20

- Oncologic results are excellent, with local tumour control and no recurrence detected during study follow-up2,18

- Multi-planar imaging and tissue contrast facilitate safely freezing near the collection system and bowel7,14,15,21

• PROSTATE:Cryoablation is a minimally invasive, efficacious treatment option for prostate cancer4,9

- Primary and salvage cryoablation can provide excellent local control with early and lasting PSA decrease9,10

- For patients who are poor surgical candidates, cryoablation provides an effective alternative10

• LIVER:For appropriate patients, cryoablation is an option for hepatic metastases6,12,19

- MR visibility of the ablation zone is a key advantage, allowing intraprocedural monitoring to avoid involvement of nearby critical structures, such as chest wall, diaphragm and gall bladder6

- Hepatic tumours ≤ 4cm can be successfully ablated with low local recurrence rates and low rates of complications17

• BONE:- Monitoring the ablation margin optimises tumour coverage23 and reduces the risk of injury to adjacent critical structures23,24,25

- Studies show clinically significant26,27 durable pain reduction for the majority of metastatic bone tumour patients treated with cryoablation24,27

- Cryoablation delivers faster pain relief28 than radiotherapy29





SYSTEM SPECIFICATIONSOPERATING CONDITIONS• Relative Humidity (operating conditions): 30% to 75% • Temperature: -15°C to + 50°C • Relative Humidity (storage): 10% to 90%

TRANSPORTATION CONDITIONS• When shipping a system, use the original shipping containers to prevent damage during transport • If the original shipping containers are not available, the customer takes responsbility to ensure proper transport conditions are satisfied or contacts Galil Customer Service to obtain the appropriate shipping container

MECHANICAL SPECIFICATIONS CONSOLE• Weight: 170lbs • Height: 42in, monitor down. 62in, monitor up • Foot print: 22x26in • Storage Compartment Weight Capacity: 50lbs • Monitor Storage Basin Weight Capacity: 20lbs • Closed Monitor Weight Capacity: 20lbs

MECHANICAL SPECIFICATIONS MOBILE CONNECTION PANEL• Weight: 45lbs • Height: 39in • Foot Print: 20x18in

MECHANICAL SPECIFICATIONS JUNCTION BOX• Wall footprint: 10x5in, protruding 4in out of the wall • Note: about 24in of clearance is needed from the front of the Junction Box to allow easy connections

MECHANICAL SPECIFICATIONS PENETRATION PANEL• Footprint: 8x6in minimum • Note: about 12in of clearance is needed from the front of the Penetration Panel to allow space for gas, electrical and fibreoptics connections

EXTERNAL GAS SUPPLY• Argon Cynlinder: Purity Level 99.998% or higher | Solid Particle size: <5µm • Helium Cynlinder: Purity Level: 99:995% or higher | Solid particle size: <5µm

GAS CYLINDER SPECIFICATIONS• Maximum pressure: 6000psi • Connector Valve: CGA677

ACCURACY OF DISPLAYED VALUES• Supplied Gas Pressure Accuracy: ±50psi, over range of 1000psi to 6000psi • Built-in Regulator Gas Pressure: ±50psi, over range of 1000psi to 4000psi• Time intervals: ±5 seconds over any 10 minute interval

ELECTRICAL SPECIFICATIONS• Input Voltage: 100 to 240 VAC, single phase • Input Frequency: 50-60Hz • VA Rating: 450 VA • IP Rating: IP10 • Fuse Rating: T 5.0A • Electrical Protection: Class I, Type BF protection against shock • Signal Input / Output Ports: one (1) Ethernet port | one (1) USB 2.0 full-speed port | one (1) Auxiliary Display port

MRI CONDITIONAL SAFETY• The Visual-ICETM MRI Cryoablation System has been tested to be safe for use with 1.5 and 3 Tesla scanners

RECOMMENDED SCAN SEQUENCES TO MINIMISE NEEDLE HEATING• Normal Operating Mode • SAR of ≤ 1.5 watts per kilogram • Scan duration less than one minute per scan

ORDERING INFORMATION

MRI CRYOABLATION NEEDLE KITS

IceSeedTM 1.5 MRI Cryoablation Needle

IceSeedTM 1.5 MRI 900 Cryoablation Needle

IceRodTM 1.5 MRI Cryoablation Needle

IceRodTM 1.5 MRI 900 Cryoablation Needle

ACTIVE THAW

Helium

Helium

Helium

Helium

NEEDLE SHAFT LENGTH

175mm

175mm

175mm

175mm

CONFIGURATION

Straight

900

Straight

900

PART NUMBER

FPRPR3192

FPRPR3194

FPRPR3193

FPRPR3195

DESCRIPTION

A cryoablation concolse with built-in gas pressure regulators; two flexible gas supplylines (one argon, one helium) with pressure gauges; a console cover.

A Visual-ICETM MRI remote Mobile Connection Panel to support MRI needleconnections in magnet room; a Mobile Connection Panel cover.

Two Visual-ICETM MRI Junction Box Assemblies containing gas, electrical and fibreoptic connectors; One Penetration Panel.

One Visual-ICETM MRI Junction Box Harness (5m) containing gas, electrical andfibre optic lines and connectors, packed in a protective case.

One Visual-ICETM MRI Junction Box Haress (10m) containing gas, electrical andfibre optic lines and connectors, packed in a protective case.

One Visual-ICETM MRI Junction Box Harness (15m) containing gas, electrical andfibre optic lines and connectors, packed in a protective case.

VISUALICETM MRI SYSTEM & ACCESSORIES

Visual-ICETM MRI Cryoablation Console

Visual-ICETM MRI Mobile Connection Panel

Visual-ICETM MRI Junction Box Assembly

Visual-ICETM MRI Junction Box Harness (5m)



PART NUMBER

FPRCH7000

FPRCH7100

FPRCH7050

ASM7005

ASM7010

ASM7015

Ordering Inform

ationO

rdering Information

Ordering Inform

ation

NOTES:



NOTES:

REFERENCES1. Kaye EA, Granlund KL, Morris EA, et al. Closed-Bore Interventional MRI: Percutaneous Biopsies and Ablations. AJR Am J Roentgenol 2015; 205(4):W400-W410.

2. van Oostenbrugge TJ, Langenhuĳsen JF, Overduin CT, et al. Percutaneous MR Imaging-Guided Cryoablation of Small Renal Masses in a 3-T Closed-Bore MR Imaging Environment: Initial Experience. J Vasc Interv Radiol 2017; 28(8):1098-1107.

3. Woodrum DA, Kawashima A, Gorny KR, Mynderse LA. Magnetic Resonance - Guided Thermal Therapy for Localized and Recurrent Prostate Cancer. Magn Reson Imaging Clin N Am 2015; 23(4):607-619.

4. Gangi A, Tsoumakidou G, Abdelli O, et al. Percutaneous MR-guided cryoablation of prostate cancer: initial-experience. Eur Radiol 2012; 22(8):1829-35.

5. Harada J, Dohi M, Mogami T, et al. Initial experience of percutaneous renal cryosurgery under the guidance of a horizontal open MRI system. Radiat Med 2001; 19(6):291-96.

6. Aghayev A, Tatli S. The use of cryoablation in treating liver tumors. Expert Rev Med Devices 2014; 11(1): 41-52.

7. Mogami T, Harada J, Kishimoto K, Sumida S. Percutaneous MR-guided cryoablation for malignancies, with a focus on renal cell carcinoma. Int J Clin Oncol 2007; 12(2):79-84.

8. Ahrar K, Ahrar JU, Javadi S, et al. Real-Time MRI-guided Cryoablation of Small Renal Tumors at 1.5 T. Invest Radiol 2013; 48(6):437-44.

9. Woodrum DA, Kawashima A, Karnes RJ. Magnetic resonance imaging-guided cryoablation of recurrent prostate cancer after radical prostatectomy: initial single institution experience. Urology 2013; 82(4):870-75.

10. Kinsman KA, White ML, Mynderse LA. Whole-Gland Prostate Cancer Cryoablation with Magnetic Resonance Imaging Guidance: One-Year Follow-Up. Cardiovasc Intervent Radiol 2017; doi: 10.1007/s00270-017-1799-6.

11. Tatli S, Acar M, Tuncali K, et al. Percutaneous cryoablation techniques and clinical applications. Diagn Interv Radiol 2010; 16(1):90-95.

12. Silverman SG, Tuncali K, Adams DF, et al. MR Imaging-guided Percutaneous Cryotherapy of Liver Tumors: Initial Experience. Radiology 2000; 217(3):657-64.

13. Kahn T, et al. MRI -Guided Thermal Ablation Techniques. Interventional Magnetic Resonance Imaging. Springer. 2013; 253-69.

14. Morrison PR, Silverman SG, Tuncali K, Tatli S. MRI-Guided Cryotherapy. J Magn Reson Imaging 2008; 27(2):410-20.

15. Shingleton WB, Sewell PE. Percutaneous renal tumor cryoablation with magnetic resonance imaging guidance. J Urol 2001; 165(3):773-76.

16. Miki K, Shimomura T, Yamada H, et al. Percutaneous cryoablation of renal cell carcinoma guided by horizontal open magnetic resonance imaging. In J Urol 2006; 13(7):880-84.

17. Glazer DI, Tatli S, Shyn PB, et al. Percutaneous Image-Guided Cryoablation of Hepatic Tumors: Single-Center Experience With Intermediate to Long-Term Outcomes. AJR Am J Roentgenol 2017; 209(6):1381-89.

18. Sewell PE, Howard JC, Shingleton WB, Harrison RB. Interventional magnetic resonance image-guided percutaneous cryoablation of renal tumors. South Med J 2003; 96(7):708-10.

19. Nair RT, Silverman SG, Tuncali K, et al. Biochemical and Hematologic Alterations Following Percutaneous Cryoablation of Liver Tumors: Experience in 48 Procedures. Radiology 2008; 248(1):303-11.

20. Kodama Y, Abo D, Sakuhara Y, et al. MR-guided percutaneous cryoablation for bilateral multiple renal cell carcinomas. Radiat Med 2005; 23(4):303-307.

21. Tuncali K, Morrison PR, Tatli S, Silverman SG. MRI-guided percutaneous cryoablation of renal tumors: use of external manual displacement of adjacent bowel loops. Eur J Radiol 2006; 59(2):198-202.

22. Silverman SG, Tuncali K, vanSonnenberg E, et al. Renal tumors: MR imaging-guided percutaneous cryotherapy - initial experience in 23 patients. Radiology 2001; 236(2):716-24.

23. Foster RCB, Stavas JM. Bone and Soft Tissue Ablation. Semin Intervent Radiol 2014; 31:167-179.

24. Callstrom MR, Kurup AN. Percutaneous ablation for bone and soft tissue metastases - why cryoablation? Skeletal Radiol 2009; 38:835-839.

25. Gangi A, Buy X. Percutaneous Bone Tumor Management. Semin Intervent Radiol 2010; 27(2):124-136.

26. Farrar JT, Young JR JP, LaMoreaux L, et al. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001; 94:149-158.

27. Prologo JD, Passalacqua M, Patel I, et al. Image-guided cryoablation for the treatment of painful musculoskeletal metastatic disease: a single-center experience. Skeletal Radiol 2014; 43:1551-1559.

28. Masala S, Schillaci O, Bartolucci AD et al. Metabolic and clinical assessment of e�cacy of cryoablation therapy on skeletal masses by F-FDG positron emission tomography/computed tomography (PET/CT) and visual analogue scale (VAS): initial experience. Skeletal Radiol 2011; 40:159-165.

29. Tong D, Gillick L, Hendrickson FR. The Palliation of Symptomatic Osseous Metastases. Final Results of the Study by the Radiation Therapy Oncology Group. Cancer 1982; 40:893-899.

FOR MORE INFORMATION ON CRYOABLATION PLEASE CONTACT USTEL UK: +44 203 3184706 FAX UK: +44 208 0434802TEL DE: +49 308 8789723 FAX DE: +49 211 95987558TEL ES: +34 911 239029 FAX ES: PENDING SET UP

FOR ALL OTHER REGIONS PLEASE CONTACT: [email protected] OUTOFOFFICE LINE: +32 479 979199

GALIL, the GALIL logo, IceEDGE, IceFORCE, IcePearl, IceRod, IceSeed, IceSphere and Visual-ICE are trademarks of Galil Medical Ltd. BTG and the BTG. roundel logo are registered trademarks and ‘Imagine where we can go’ is a trademark of BTG International Ltd. Galil Medical Inc and Galil Medical Ltd are BTG International group companies. © 2018 Galil Medical Inc. April 2018 EM-GMPVIS-2018-0350

Indications for Use: The Galil Medical Cryoablation Systems are intended for cryoablative destruction of tissue during surgical procedures; various Galil Medical ancillary products are required to perform these procedures. Galil Medical Cryoablation Systems are indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, cardiac exclusion, ENT, gynecology,oncology, proctology and urology. These Systems are designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and skin lesions) by the application of extremely cold temperatures. A full list of specific indications can be found in the Galil Medical Cryoablation System User Manuals.

Contraindications: There are no known contraindications. Warnings / Precautions / Adverse Events: A thorough understanding of the technical principles, clinical applications, and risks associated with cryoablation procedures is necessary before using Galil Medical products to conduct cryoablation. Use of such products should be restricted to use by or under the supervision of physicians trained in cryoablation procedures with a Galil Medical Cryoablation System. A full list of the warnings, precautions, and adverse events can be found by referencing the respective device Instructions for Use document or Cryoablation System User Manual. Rx only



THE LEADING EDGE IN CRYOABLATION - Sanovamedicalsystems.sanova.at/download/kryoablation/Visual_ICE_MRI.pdf · Percutaneous MR-guided cryoablation of prostate cancer: initial-experience.

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