ALISO VIEJO, California— BioLucent, Inc. has received 510(k) clearance from the FDA for its SAVI applicator. The SAVI device offers a multicatheter, single-entry approach to breast brachytherapy. SAVI combines the tissue-sparing dosimetry of interstitial brachytherapy with the single-entry ease of intracavitary (“balloon”) brachytherapy, the company said in a press release
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 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 physician to better contour and control the radiation dose.