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INTENDED USE
The Visual-ICE Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive
procedures; various Boston Scientific accessory products are required to perform these procedures� The Visual-ICE
Cryoablation System is intended for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology
(including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), gynecology, oncology, 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�
Patient Groups
The intended population includes patients intended for cryoablative destruction of tissue during surgical procedures�
INDICATIONS FOR USE
The Visual-ICE 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), gynecology,
oncology, 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 Cryoablation System has the following specific indications:
• Urology - Ablation of prostate tissue in cases of prostate cancer
• Oncology - Ablation of cancerous or malignant tissue and benign tumors, and palliative intervention
• Dermatology - Ablation or freezing of skin cancers and other cutaneous disorders
• Gynecology - Ablation of malignant neoplasia or benign dysplasia of the female genitalia
• General surgery - Palliation of tumors, recurrent cancerous lesions, and ablation of breast fibroadenomas
• Thoracic surgery - (with the exception of cardiac tissue)
Clinical Benefit Statement
The Visual-ICE Cryoablation System, when used with various Boston Scientific accessory products, is intended to
destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and skin lesions) by the application of
extremely cold temperatures during minimally invasive procedures�
The clinical benefit is measured by overall clinical outcomes with acceptable safety specific to the target anatomy
and indication�
CONTRAINDICATIONS
There are no known contraindications specific to the use of the Visual-ICE Cryoablation System�
WARNINGS
General
• The Visual-ICE Cryoablation System is designed to be operated by medical professionals who have a thorough
understanding of the technical principles, clinical applications, and risks associated with cryoablation
procedures�
• See Boston Scientific cryoablation needle and accessory product IFUs for Warnings specific for these products�
• Do not use this device for any purpose other than the stated intended use and indications for use�
• Do not modify the Visual-ICE Cryoablation System in any way� Only authorized Boston Scientific personnel or
Boston Scientific-trained authorized personnel are to service Visual-ICE Cryoablation Systems�
• The Visual-ICE Cryoablation System should be inspected and serviced periodically according to the system
specifications� Service must be performed by authorized service engineers� Reference the Installation,
Calibration, and Servicing Section for detailed information�
• Do not use the Visual-ICE Cryoablation System if the system is visibly damaged, exposing any internal
components or sharp edges�
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