StarBurst® XL RFA Device
Because Temperature Matters
The StarBurst XL RFA device creates 1-5 cm ablations, and the active tip can also be used for needle track ablation to prevent complications. The device has nine active electrodes and five thermocouples positioned throughout the array that provide real-time temperature feedback.
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By monitoring the temperatures at the margins of the ablation zone physicians are able to ensure that the ablation is successful in destroying targeted tissue. Electrodes within the array configuration are well-distributed and are engineered with a "space-filling" design.
Scalability Means Flexibility
With its adjustable array size, the StarBurst XL makes it easy for physicians to create spherical zones of ablation from 3-5 cm with a single needle placement.
The StarBurst XL RFA electrode also is available with a pre-attached main cable for improved ease of use.
StarBurst® Semi-Flex RFA Device
The StarBurst Semi-Flex RFA device offers the same benefits of its parent device with the addition of a trocar that bends in all directions (up to 90 degrees), the StartBurst Semi-Flex gives physicians the ability to properly place the device and then clear CT gantries during image guided percutaneous RF procedures.
Important Risk Information
INDICATION FOR USE: The StarBurst XL Electrosurgical Device is a tool to transmit monopolar radiofrequency energy (provided by the Model 1500X RF Generator) and 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 these devices to sale 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 needles; 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. Ensure that the device is placed at least 1 cm away from structures not intended for ablation. 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. 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.