BREAKING BOUNDARIES WITH ICE

Transcription

1 IcePearl 2.1 CX L Needle IceFORCE 2.1 CX L Needle 23cm Length for Deep Tumours IceSphere 1.5 S Needle Short Shaft for Superficial Lesions IcePearl 2.1 CX Needle IceFORCE 2.1 CX Needle Large Ice, Smaller Profile, Most Options Dual-Stage Gas Dryers Superior Freezing Performance 37 C Isotherm Data Improved Procedure Planning IceSphere 1.5 Needle Short, Spherical Ice IceRod 1.5 CX Needle Ice Plus Cautery i-flow Technology Optimised Needle Performance Visual-ICE System Intuitive User Interface IceEDGE 2.4 Needle Largest Ice IceRod 1.5 PLUS Needle Lightweight, Narrow Profile OCTOBER 16 MARCH 16 SEPTEMBER 15 JUNE 15 SEPTEMBER 14 JULY 14 MARCH 14 SEPTEMBER 13 MARCH 12 OCTOBER 11 JUNE 11 BREAKING BOUNDARIES WITH ICE

2 BREAKING BOUNDARIES WITH ICE To optimise tumour coverage and provide appropriate margins, the use of multiple needles is recommended. Multiple needles placed in an adjacent configuration will typically create a large, coalesced iceball. In clinical use, patient anatomy, tissue and tumour properties affect needle placement. Needle type, number of needles placed, tissue and tumour characteristics, surrounding vasculature and treatment duration affect iceball size. Monitoring iceball formation provides direct control throughout the procedure and is key to successful cryoablation. Iceball dimensions are provided to assist users in selecting the cryoablation needle(s) and needle placement to appropriately ablate the target area. To optimise appropriate margins, needles should be placed to create lethal ice beyond the perimeter of the target tissue. Note: The - C isotherm is.5cm from the edge of the visible ice. Needle testing was conducted in a laboratory setting in either 37 C temperaturecontrolled gel or in room-temperature gel. Isotherm measurements were made following two -minute Freeze cycles, separated by a 5-minute passive Thaw cycle.

3 CRYOABLATION NEEDLE ISOTHERM DATA Room temperature gel ISOTHERM DATA -2-4 IceRod 1.5 Family C 43mm x 6mm - C 28mm x 47mm - C 17mm x 41mm IceFORCE 2.1 CX Family C 5mm x 64mm - C 35mm x 51mm - C 24mm x 43mm IceEDGE 2.4 C 49mm x 63mm - C 34mm x 51mm - C 22mm x 43mm IcePearl 2.1 CX Family C 44mm x 49mm - C mm x 35mm - C mm x 27mm IceSphere 1.5 Family C 39mm x 45mm - C 26mm x 32mm - C 16mm x 24mm IceSeed 1.5 C 33mm x 38mm - C mm x 27mm - C 11mm x mm Actual Size 5

4 CRYOABLATION NEEDLE ISOTHERM DATA 37 C GEL Needle Placement Guide Select needles appropriate for the application, tumour location and tumour size Choose needle type and number of needles to surround the tumour with lethal ice Note: C ice (the visible edge of the iceball) is not lethal Iceball shape and size for each needle type are displayed on this chart An iceball must extend 5-mm beyond the tumour margin for appropriate coverage Use multiple needles to fully cover a target site and provide a suitable margin Place needles no further than 1cm from the tumour edge 1cm from edge Needle tips extend 5-mm beyond tumour edge IceFORCE 2.1 CX Family Optimal spacing: cm IceFORCE 2.1 CX 9ryoablation IceFORCE 2.1 CX L 9ryoablation Radial width 2.5mm; Length 29mm IcePearl 2.1 CX Family Optimal spacing: cm IcePearl 2.1 CX 9ryoablation IcePearl 2.1 CX L 9ryoablation Radial width 2.1mm; Length 13mm IceRod 1.5 Family Optimal spacing: cm IceRod 1.5 CX 9 * IceRod 1.5 PLUS 9 IceRod Radial width 2.3mm; Length mm C 42mm x 57mm - C 32mm x 49mm - C 23mm x 42mm -4-2 C 36mm x 41mm - C 27mm x 32mm - C 18mm x 26mm IceRod 1.5 CX C 36mm x 53mm - C 26mm x 45mm - C 17mm x 39mm IceRod 1.5 PLUS C 35mm x 52mm - C 25mm x 45mm - C 16mm x mm -4-2 C 61mm x 5mm - C 52mm x mm - C 42mm x mm -4-2 C 51mm x 44mm - C 41mm x 34mm - C 32mm x 25mm -4-2 C 51mm x 45mm - C 41mm x 35mm - C mm x 25mm -4-2 C 64mm x 67mm - C 54mm x 56mm - C 44mm x 47mm -4-2 C 6mm x 53mm - C 49mm x 43mm - C mm x 34mm -4-2 C 59mm x 54mm - C 49mm x 44mm - C 39mm x 34mm -4-2 C 71mm x 73mm - C 61mm x 62mm - C 5mm x 52mm -4-2 C 61mm x 62mm - C 51mm x 52mm - C 41mm x 44mm -4-2 C 6mm x 61mm - C 51mm x 51mm - C mm x 42mm Extend the needle tip beyond the distal edge of the tumour to ensure appropriate coverage with lethal ice Note the - C ice extends less than 5mm beyond the needle tip IceEDGE 2.4 Optimal spacing: cm IceEDGE Space needles as recommended on the chart Multiple needles placed in an adjacent configuration will typically create a large, coalesced iceball Needles spaced too far apart risk areas of non-lethal ice Confirm with imaging the iceball completely engulfs the tumour with a 5-mm margin IceSphere 1.5 Family Optimal spacing: cm IceSphere 1.5 9ryoablation Needle IceSphere 1.5 S 9ryoablation Needle 5 6 C mm x 55mm - C mm x 48mm - C 21mm x 41mm C 59mm x 5mm - C 49mm x 39mm - C 39mm x 28mm C 66mm x 66mm - C 56mm x 56mm - C 45mm x 48mm C 71mm x 73mm - C 62mm x 62mm - C 52mm x 53mm C 33mm x 37mm - C 23mm x 29mm - C 15mm x 23mm C 48mm x 41mm - C 38mm x 32mm - C 29mm x 22mm C 54mm x 5mm - C 45mm x mm - C 36mm x 31mm C 58mm x 59mm - C 48mm x 49mm - C 38mm x 41mm IceSeed 1.5 Optimal spacing: 1.cm IceSeed 1.5 9ryoablation Needle C 24mm x mm - C 15mm x mm - C 8mm x mm C 36mm x 33mm - C 25mm x 23mm - C 17mm x 14mm C 41mm x 45mm - C 32mm x 34mm - C 23mm x 26mm C 48mm x 48mm - C 38mm x 38mm - C 28mm x 29mm Extend ice 5-mm beyond tumour edge

5 BREAKING BOUNDARIES WITH ICE The following chart lists 9 needles; contact your local BTG representative for straight and MRI conditional needle features and order numbers. REF Shaft Diameter (mm / ~ gauge) Shaft Length (cm) Track Ablation Radial width/length IceSeed 1.5 9ryoablation Needle FPRPR32 1.5mm / 17G 17.5cm NA IceSphere 1.5 9ryoablation Needle IceSphere 1.5 S 9ryoablation Needle IceRod 1.5 9ryoablation Needle IceRod 1.5 PLUS 9ryoablation Needle IceRod 1.5 CX 9ryoablation Needle IcePearl 2.1 CX 9ryoablation Needle IcePearl 2.1 CX L 9ryoablation Needle IceFORCE 2.1 CX 9ryoablation Needle IceFORCE 2.1 CX L 9ryoablation Needle IceEDGE 2.4 9ryoablation Needle FPRPR mm / 17G 17.5cm NA FPRPR mm / 17G.cm NA FPRPR34 1.5mm / 17G 17.5cm NA FPRPR mm / 17G 17.5cm NA FPRPR mm / 17G 17.5cm 2.3mm/mm FPRPR mm / 14G 17.5cm 2.1mm/13mm FPRPR mm / 14G 23.cm 2.1mm/13mm FPRPR mm / 14G 17.5cm 2.5mm/29mm FPRPR mm / 14G 23.cm 2.5mm/29mm FPRPR mm / 13G 17.5cm NA Galil Medical s may not be available in all markets Intended Use: Galil Medical patented s are components used in conjunction with a Galil Medical Cryoablation System when performing cryoablative tissue destruction through application of extremely cold temperatures. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application. Indications for Use: Galil Medical s are intended for cryoablative destruction of tissue during surgical procedures. The cryoablation needles, used with a Galil Medical Cryoablation System, are indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology and urology. Galil Medical Cryoablation Systems are designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumours, 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 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 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. only 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. 17 Galil Medical Inc. EM-GMCRYO October 17