The UniBlate RFA electrode provides linear, scalable and cylindrical ablations from 1 to 3 cm in length and 1 to 2.5 cm in diameter. It is used in ablating lesions close to critical structures.
The UniBlate electrode provides a very low profile for CT gantry compatibility. A built-in thermocouple provides full temperature feedback and RF power control, as well as a cool down cycle andtrack ablation capabilities.
Features & Benefits
- UniBlate exclusive linear deployment electrode feature allows user to "dial in"the desired length of active electrode
- The most CT-gantry compatible electrode available with right angle cable connection
- Built in cool down process after each ablation
- Provides full track ablation capabilities
- Added safety near critical structures
Important Risk Information
INDICATION FOR USE: The UniBlate Electrosurgical Device is a tool to transmit monopolar radiofrequency energy (provided by the RITA® RF Generator) in conjunction with the IntelliFlow Infusion pump. It is indicated for use in percutaneous, laparoscopic, or intraoperative coagulation and ablation of soft tissue including the partial or complete ablation of non-resectable liver lesions and palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard pain therapy. CAUTION: Federal (USA) law restricts the sale of this device by or on the order of a physician. CONTRAINDICATIONS: None known. WARNINGS AND PRECAUTIONS: For single use only. Do not bend or kink the trocar or the needle or exert forceful pressure on Device while it is in the tissue; do not attach anything (i.e., clamps, etc.) to the Device, or use metal introducers that do not have insulation; inadvertent patient injury may result. To ensure safe and effective use follow the manufacturer’s directions and recommended practices for the preparation, placement, surveillance, removal and use of the dispersive electrode. To achieve the desired ablation follow the manufacturer’s guidelines of ablation time and temperature. The distal 4 mm of the device is not radiopaque and will not appear under CT imaging. In laparoscopic procedures, care must be taken to avoid a gas embolism, and activation of the device when not in contact with target tissue may cause capacitive coupling. In some cases, a liver lesion will only be partially destroyed; the final determination of the success of lesion destruction can only be made by imaging studies following the procedure and during regular long-term follow-up. For ablation of painful bone metastases, do not perform RF ablation in weight-bearing bone with evidence of impending fracture. Pathologic fracture is more prevalent and serious in long bone. The UniBlate is not MRI safe. Please see package insert for complete list of warnings and precautions. POTENTIAL COMPLICATIONS: Published reports on the use of the RFA system indicate low overall complication rates. These include bleeding, abscesses and, in cases involving the treatment of bone tumors, fractures and nerve damage.
Indications, contraindications, warnings and instructions for use can be found in the instructions for use supplied with each device. Observe all instructions prior to use. Failure to do so may result in patient complications.