StarBurst® SDE RFA Device
Designed for Small Lesions
The StarBurst SDE RFA device 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. The innovative StarBurst SDE RFA allows for small spherical (2 cm) and oval (2 x 1 cm) ablations. With its smaller trocar and sharp tip, the StarBurst SDE RFA device is the least invasive device in AngioDynamics’ electrosurgical device product line.
Because Temperature Matters
Like its sister products, the StarBurst SDE RFA device provides real-time, multi-point temperature feedback and single needle technology. The StarBurst SDE’s small, sharp trocar tip can also be used as a straight needle electrode.
The StarBurst SDE RFA device also is available with a pre-attached main cable for improved ease of use.
Important Risk Information
INDICATION 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.