StarBurst® SDE RFA DeviceThe StarBurst SDE RFA electrode features a first in the industry: unique, side-deployed arrays that allow physicians to precisely position the trocar tip and see its location with greater ease. It is designed for small lesions, where a finer gauge may be of benefit. With the StarBurst SDE RFA electrode, stage deployment is not required. Instead, physicians deploy the device to the desired size and maintain the prescribed temperature and duration to complete the ablation. Like all StarBurst RFA devices, the SDE features controlled temperature monitoring, through multi-point temperature feedback.
- Straight needle with side-deployed arrays
- Small needle gauge and sharper trocar tip for easier access into the lesion site
- Smaller spherical ablations (2 cm)
- Dynamic, real-time temperature readouts
- Multi-point temperature feedback
- Patented side-deployment array design†
- Three arrays plus active trocar tip
- Three thermocouples
† Covered by one or more of the following US patents: 5472441, 5486161, 5536267, 5672173, 5672174, 5683384, 5728143, 5782827, 5863290, 5913855, 5928229, 5935123, 5980517, 6071280, EP 0 777 445 B1, and Japanese patent 3009735. Other patents pending.
Important Risk InformationINDICATION FOR USE: The StarBurst® MRI and SDE Electrosurgical Devices transmit monopolar radiofrequency energy (provided by the Model 1500X RF Generator) and are 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 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.