BioLucent, Inc. has received 510(k)clearance from the FDA for its SAVIapplicator. The SAVI device offersa multicatheter, single-entry approachto breast brachytherapy.
ALISO VIEJO, California--BioLucent, Inc. has received 510(k)clearance from the FDA for its SAVIapplicator. The SAVI device offersa multicatheter, single-entry approachto breast brachytherapy.SAVI combines the tissue-sparingdosimetry of interstitial brachytherapywith the single-entry easeof intracavitary ("balloon") brachytherapy,the company said in a pressrelease
The applicator is for use in acceleratedpartial breast irradiation(APBI) treatment following alumpectomy. The device includesan expandable bundle of cathetersthat surround a central lumen. Theapplicator is placed into the lumpectomycavity through a small incision.The physician expands thecatheter bundle by turning a mechanismfrom outside the breast. Thecatheters expand to form an ellipsoidalshape inside the cavity. Deliveryof radiation through the device'sindividual catheters allowsthe physician to better contour andcontrol the radiation dose.