New Product

November 1, 2006
Oncology NEWS International, Oncology NEWS International Vol 15 No 11, Volume 15, Issue 11

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.