Healthcare Industry News:  SAVI Applicator 

Devices Oncology FDA

 News Release - October 24, 2006

BioLucent Receives FDA Clearance for SAVI, a New Breast Brachytherapy Device

ALISO VIEJO, Calif.--(HSMN NewsFeed)--BioLucent, Inc. announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration for its SAVI(TM) applicator.
The SAVI device offers a multi-catheter, 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.

More precise delivery of radiation may help avoid radiation damage to the skin or chest wall that can occur with other breast brachytherapy procedures, and may also make the benefits of accelerated partial breast irradiation accessible to a larger group of women.

APBI was developed as an alternative to whole-breast irradiation. Both whole-breast irradiation and APBI are used after lumpectomy to help prevent local recurrence of breast cancer.

The course of treatment for whole-breast irradiation is five to seven weeks, with five treatments per week. According to research, this lengthy treatment period prompts some women to opt for complete removal of the breast, rather than a breast-sparing lumpectomy procedure with whole-breast irradiation.

With APBI, treatment lasts one week or less. Other potential advantages of APBI include improved access to radiation therapy facilities, lower risk of injury to healthy tissue, and a faster transition to chemotherapy.

SAVI was developed by BioLucent, Inc., the women's health company dedicated to early detection and treatment of breast cancer. BioLucent also manufactures and markets the MammoPad breast cushion, a radiolucent, FDA-cleared foam cushion that covers the cold, hard surfaces of all commercially available mammography equipment. When MammoPad is used, three out of four women experience a 50% decrease in mammography-related pain.

For more information about BioLucent, call (toll-free) 866-460-4141 or access

Source: BioLucent

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