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The Focused Cryotherapy System is intended for cryoablative destruction of tissue during surgical procedures. The Focused Cryotherapy 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. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, nerves, tumors, and skin lesions.

In addition, the system is intended for use in the following 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. Palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard radiation therapy

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

Neurology

• Freezing of nerve tissue in pain management/cryoanalgesia

The Focused Cryotherapy System is a cryoablation platform that contains the following components:

• Probe (FC-2021CD01)
• Console (FC-AR401)
• Software

The Focused Cryotherapy System is a cryoablation platform for use in the cryoablation of nerves and tumors. The Probe is a handheld, single use, cryosurgical instrument. The Probe utilizes a high-pressure cryogen (argon gas) to freeze target tissues, creating an inflammatory response, and ultimately, cryonecrosis. In use with tumors, temperatures below -40°C is the temperature at which intracellular ice formation occurs which is lethal for cells. When applied to nerves, temperatures below -20°C cause extracellular ice formation along axonal tubes which causes cessation of action potential conduction. When high pressure argon gas is supplied to the Probe via the Console, rapid cooling is achieved via the Joule-Thomson effect. The Probe incorporates a heating element to facilitate directional cryoablation. The Console has combination gas/electrical ports to handle 4 Probes in parallel. The Console contains the Firmware and Software. The System consists of a main chassis (Console) for the cooling system, Firmware, Software, controls, touch screen and Probe ports. Safety measures of the system include audible and visual alarms, safety valves, and emergency shutoff button.

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