ICEfx™ Brief Summary

Indications, Safety and Warnings

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.

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 ICEfx™ 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. CAUTION: Carefully read all instructions prior to use. Failure to observe all warnings and precautions may result in complications.

INDICATIONS

The Galil Medical ICEfx 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 ICEfx 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 ICEfx 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 ICEfx 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 ICEfx Cryoablation System.

ADVERSE EVENTS

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.

 

PI-719210-AA

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