FDA clears expanded size offering of mammosite device.

2003 JUN 19 - (NewsRx.com & NewsRx.net) -- Proxima Therapeutics, Inc., a developer and marketer of site-specific therapies that deliver internal radiation treatment, has received marketing clearance from the U.S. Food and Drug Administration (FDA) for a new, larger-sized MammoSite balloon catheter.

MammoSite, an internal radiation therapy delivery system for breast cancer, will now include the option of a spherical balloon catheter capable of expanding 5-6 cm in diameter. The larger balloon catheter will enable women with larger tumor cavities to be eligible for this treatment. The smaller 4-5 cm balloon catheter will continue to be available.

Breast conservation therapy, a less invasive course of treatment than mastectomy, typically involves tumor excision via lumpectomy followed by radiation therapy to reduce the likelihood of recurrence. Since its FDA clearance 1 year ago, MammoSite has helped make breast conservation therapy an option for more ...