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Descripción del producto
Presice Cryosurgical System, model FPRCH2047, and the following system is not approved in the US: CryoHit-P Cryoblation System, model FPRCH2058. The system is a software controlled cryoblation system designed to destroy targeted tissue using a minimally invasive percutaneous approach. Freezing and thawing of the tissue is achieved through the use of the Joule-Thompson effect, using a high-pressure gas distributed through closed-end needles placed into the patient;s target organ. || Presice is intended for cryogenic destruction of tissue during surgical procedures. Presice is 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. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. Presice 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 hemanglomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal 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, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenoma); * ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth); " Thoracic surgery (ablation of arrhythmic cardiac tissue cancerous lesions); * Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids). The Presice system may be used with an ultrasound device to provide real-time visualization of the cryosurgical procedure.