The Visual ICE MRI offers a safe and efficient cryoablation procedure facilitating precise and effective treatment without the need for surgery or repeated radiation treatments

• The Mobile Connection Panel (MCP) is placed within the MR room, allowing for easy access to both the patient and the needles during a procedure.
• Sixteen needles may be simultaneously connected, allowing a range of cryoablation procedures.

Custom Designed for Each MRI Environment

• Each system design accommodates customer and site requirements.
• Integrated into MR rooms with minimal installation and minimal downtime.

Consolidated Lines Facilitate Connections

• The Junction Box Harness organizes gas, fiber optic, and electrical lines into a single cable.
• Connectors are easily aligned and securely clicked into place.

MRI Cryoablation Needles

Used with the Visual ICE MRI Cryoablation System, our MRI needles leverage the unique advantages of cryoablation zone visibility with the exquisite image resolution of MR.

Classic MRI Needles: IceRod™ MRI and IceSeed™ MRI

• Straight or angled 90° needle configurations in a choice of lengths and diameters.
• Three-facet sharp needle tip of easy percutaneous insertion and control.
• Accurate shaft distance markers to optimize needle placement.
• Lightweight handles to minimize torque on inserted needles, with color-coding for ease of identification.
• Unibody closed-tube design which minimizes risk of gas leakage vs welded tip designs.

WARNINGS

A thorough understanding of the technical principles, clinical applications, and risk associated with cryoablation procedures is necessary before using this product. Use of this device is restricted to use by or under the supervision of physicians trained in cryoablation procedures with a Galil Medical Cryoablation System CAUTION: All new users must be trained on the use of the Visual ICE MRI Cryoablation System and cryoablation procedures prior to operating the system. Contact your local Galil Medical representative to schedule training. CAUTION: Carefully read all instructions prior to use. Failure to observe all warnings and precautions may result in complications.

INDICATIONS

The Galil Medical VisualcICE MRI Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedures; various Galil Medical accessory products are required to perform these procedures. The Visual ICE MRI Cryoablation System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology. This system is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and skin lesions) by the application of extremely cold temperatures.

The Visual ICE MRI Cryoablation System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology. This system is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and skin lesions) by the application of extremely cold temperatures. The Visual ICE MRI Cryoablation System has the following specific indications:

• Urology Ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia (BPH)
• Oncology Ablation of cancerous or malignant tissue and benign tumors, and palliative intervention
• Dermatology Ablation or freezing of skin cancers and other cutaneous disorders Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratosis, cavernous hemangiomas, peri-anal condylomata, and palliation of tumors of the skin
• Gynecology Ablation of malignant neoplasia or benign dysplasia of the female genitalia
• General surgery Palliation of tumors of the rectum, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenomas
• ENT Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth
• Thoracic surgery (with the exception of cardiac tissue)
• Proctology Ablation of benign or malignant growths of the anus or rectum

CONTRAINDICATIONS

There are no known contraindications specific to the use of the Galil Medical Visual ICE MRI Cryoablation System.

IceSeed 1.5 MRI, IceRod 1.5 MRI

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INDICATIONS

The Galil Medical 1.5 MRI Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures. The 1.5 MRI Cryoablation Needles, used with a Galil Medical MRI Cryoablation System, are indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, proctology and urology. Galil Medical MRI Cryoablation 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 respective Galil Medical MRI Cryoablation System User Manual.

CONTRAINDICATIONS

There are no known contraindications specific to use of the Galil Medical 1.5 MRI Cryoablation Needles.

Potential adverse events which may be associated with the use of cryoablation may be organ specific or general and may include, but are not limited to abscess, adjacent organ injury, allergic/anaphylactoid reaction, angina/ coronary ischemia, arrhythmia, atelectasis, bladder neck contracture, bladder spasms, bleeding/hemorrhage, creatinine elevation, creation of false urethral passage, cystitis, death, deep vein thrombosis (DVT), delayed/non healing, diarrhea, disseminated intravascular coagulation (DIC), ecchymosis, edema/swelling, ejaculatory dysfunction, erectile dysfunction (organic impotence), fever, fistula, genitourinary perforation, glomerular filtration rate elevation, hematoma, hematuria, hypertension, hypotension, hypothermia, idiosyncratic reaction, ileus, impotence, infection, injection site reaction, myocardial infarction, nausea, neuropathy, obstruction, organ failure pain, pelvic pain, pelvic vein thrombosis, penile tingling/numbness, perirenal fluid collection, pleural effusion, pneumothorax, probe site paresthesia, prolonged chest tube drainage, prolonged intubation, pulmonary embolism, pulmonary insufficiency/failure, rectal pain, rectourethral fistula, renal artery/renal vein injury, renal capsule fracture, renal failure, renal hemorrhage, renal infarct, renal obstruction, renal vein thrombosis, scrotal edema, sepsis, skin burn/frostbite, stricture of the collection system or ureters, stroke, thrombosis/thrombus/embolism, transient ischemic attack, tumor seeding, UPJ obstruction/ injury, urethral sloughing, urethral stricture, urinary fistula, urinary frequency/urgency, urinary incontinence, urinary leak, urinary renal leakage, urinary retention/oliguria, urinary tract infection, vagal reaction, voiding complication including irritative voiding symptoms, vomiting, wound complication, and wound infection.

IceSeed 1.5 MRI, IceRod 1.5 MRI

There are no known adverse events related to the specific use of the Cryoablation Needles. There are, however, potential adverse events associated with any surgical procedure. Potential adverse events which may be associated with the use of cryoablation may be organ specific or general and may include, but are not limited to abscess, adjacent organ injury, allergic/anaphylactoid reaction, angina/coronary ischemia, arrhythmia, atelectasis, bladder neck contracture, bladder spasms, bleeding/hemorrhage, creation of false urethral passage, creatinine elevation, cystitis, diarrhea, death, delayed/non healing, disseminated intravascular coagulation (DIC), deep vein thrombosis (DVT), ecchymosis, edema/swelling, ejaculatory dysfunction, erectile dysfunction (organic impotence), fever, fistula, genitourinary perforation, glomerular filtration rate elevation, hematoma, hematuria, hypertension, hypotension, hypothermia, idiosyncratic reaction, ileus, impotence, infection, injection site reaction, myocardial infarction, nausea, neuropathy, obstruction, organ failure, pain, pelvic pain, pelvic vein thrombosis, penile tingling/numbness, perirenal fluid collection, pleural effusion, pneumothorax, probe site paresthesia, prolonged chest tube drainage, prolonged intubation, pulmonary embolism, pulmonary insufficiency / failure, rectal pain, renal artery/renal vein injury, renal capsule fracture, renal failure, renal hemorrhage, renal infarct, renal obstruction, renal vein thrombosis, rectourethral fistula, scrotal edema, sepsis, skin burn/frostbite, stricture of the collection system or ureters, stroke, thrombosis/thrombus/embolism, transient ischemic attack, tumor seeding, UPJ obstruction/injury, urethral sloughing, urethral stricture, urinary fistula, urinary frequency/ urgency, urinary incontinence, urinary leak, urinary renal leakage, urinary retention/ oliguria, urinary tract infection, vagal reaction, voiding complication including irritative voiding symptoms, vomiting, wound complication, and wound infection. renal hemorrhage, renal infarct, renal obstruction, renal vein thrombosis, rectourethral fistula, scrotal edema, sepsis, skin burn/frostbite, stricture of the collection system or ureters, stroke, thrombosis/ thrombus/embolism, transient ischemic attack, tumor seeding, UPJ obstruction/ injury, urethral sloughing, urethral stricture, urinary fistula, urinary frequency/ urgency, urinary incontinence, urinary leak, urinary renal leakage, urinary retention/ oliguria, urinary tract infection, vagal reaction, voiding complication including irritative voiding symptoms, vomiting, wound complication, and wound infection.