BioLucent Inc. has received clearance from the U. S. FDA for its SAVI applicator. The SAVI device offers a multicatheter, single-entry approach to breast brachytherapy, a procedure that helps treat cancer through radiation sources placed inside the breast.
SAVI combines the tissue-sparing dosimetry of interstitial brachytherapy with the single-entry ease of intracavitary ("balloon") brachytherapy. This new hybrid approach is designed to give more flexibility in treatment planning to the radiation oncologist and physicist.
The applicator is for use in accelerated partial breast irradiation (APBI) treatment following a lumpectomy. The device includes an expandable bundle of catheters that surround a central lumen. The applicator is placed by the physician into the lumpectomy cavity through a small incision.
The physician expands the catheter bundle by turning a mechanism from outside the breast. The catheters expand to form an ellipsoidal shape inside the cavity. Delivery of radiation through the device’s individual catheters allows the doctor to better contour and control the radiation dose.