Oncology NEWS International. Vol. 11 No. 7

FDA Approves MammoSite Radiation Therapy System for Use With Lumpectomy

July 1, 2002

ROCKVILLE, Maryland—The FDA has approved the MammoSite Radiation Therapy System (Proxima Therapeutics, Alpharetta, Georgia), to deliver adjuvant radiation therapy after breast-conserving surgery for patients with early-stage disease. The device is designed to irradiate the surgical site with minimal exposure to surrounding tissue. It consists of a hollow catheter, to which an inflatable balloon is attached. After surgery, the device is implanted, the balloon inflated, and a radiation source is placed in the catheter. The balloon centers the radiation source at the wound site. After a series of treatments, generally extending over several days, the catheter is withdrawn.

FDA approval was based on data from 25 women treated at eight centers. The FDA required Proxima to include a warning in its labeling that clinical trials have not proven MammoSite to be safe and effective as a replacement for whole breast irradiation in women undergoing mammography.

TOPIC INDEX

Cancer Types
Breast Breast (HER2+) Breast (Triple-Negative) CML Colorectal Gastrointestinal GIST Genitourinary Gynecologic Head & Neck	Hematology Kidney (Renal Cell) Leukemia Lung Lymphoma Melanoma Multiple Myeloma Ovarian Prostate Sarcoma
Supportive Care	More Topics
Bone Metastases End-of-Life Care Palliative Care	Ethics in Oncology Practice Management Practice & Policy

All Topics

FROM PHYSICIANS PRACTICE

Five Steps to Improving Patient Access
Judy Capko, May 21, 2013
Patient access is getting increased attention through reform initiatives. Here are five steps you can take to make sure patients get appropriate access to care in your office.

Growing HIPAA Threat – Ignore Windows XP at Your Own Peril
Marion K. Jenkins, May 21, 2013
Chances are good that you have some major ticking software time bombs lurking in your medical practice's computer environment, namely Windows XP and Server 2003.

Finding Physician Work-Life Balance in the Small Moments
Jennifer Frank, MD, May 21, 2013
At my practice and at home, things are always busy. There's laundry or homework, or a patient with needs.

Three Areas to Reduce Costs at Your Medical Practice
Greg Mertz, May 19, 2013
By taking a hard look at reducing costs for staffing, overhead, and technology at your medical practice, you may see increased physician compensation.

Dos and Don’ts for Starting a Physician Blog
Michael Woo-Ming, MD, May 18, 2013
Starting a physician blog can provide your medical practice with marketing benefits, but it's important to do it right.

FDA Approves MammoSite Radiation Therapy System for Use With Lumpectomy

Join the Conversation