Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

Radiation Therapy System FDA-Cleared To Treat Early-Stage Breast Cancer

September 2, 2009 By AxoGen, Inc.

The MammoSite ML (multi-lumen) device offers more women the option of completing their radiation treatment in just five days

BEDFORD, Mass., Sept. 1 /PRNewswire-FirstCall/ — Hologic, Inc. (Hologic or the Company) (Nasdaq: HOLX), a developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, today announced the U.S.

Food and Drug Administration (FDA) cleared the Company’s 510K application for the MammoSite ML radiation therapy system. With its multi-lumen design, this new device gives radiation oncologists the ability to shape the radiation dose for typical cases and treat patients who are otherwise not appropriate candidates for traditional brachytherapy.

Hologic’s MammoSite therapy system, first cleared by the FDA in 2002 as a single-lumen device, is the most widely used form of accelerated partial breast irradiation (APBI) in the United States. It has been used to treat more than 50,000 breast cancer patients in the U.S.

By employing the MammoSite system, the physician can deliver targeted radiation therapy directly to the area where cancer is most likely to recur,(i) allowing a full course of radiation to be delivered in just five days. Additionally, targeted therapy of the breast limits radiation exposure to normal, healthy tissue.
This targeting helps minimize side effects such as skin discoloration and scarring, burning, fatigue, and damage to surrounding organs.

In 2008, approximately 240,000 cases of breast cancer were confirmed in the U.S. Fortunately, today more than half of breast cancers are diagnosed when the disease is still in its localized stage.(ii) Early detection allows breast cancer patients to choose breast conservation therapy, which preserves the breast by relying on tumor excision via lumpectomy, followed by radiation therapy, to reduce the likelihood of recurrence. According to the National

Institutes of Health, breast-conserving surgery plus radiation therapy is preferable to total mastectomy because it provides survival equivalence while preserving the breast.(iii)

The MammoSite systems are comprised of an inflatable balloon catheter in which a radioactive source is introduced for therapy delivery. The inflatable balloon is inserted into the surgical cavity remaining after removal of the tumor. This local placement of the balloon provides for therapeutic delivery of a five-day course of radiation to the tissue most likely to contain residual cancerous cells following surgery, while reducing radiation exposure to adjacent healthy tissue. Using the MammoSite multi-lumen catheter, the radiation oncologist has the ability to shift the radiation dose to the areas that need it most and shift the dose away from areas that do not require it.

"An increasing number of surgeons, radiation oncologists, and patients are choosing the accelerated treatment available with MammoSite," said David Harding, senior vice president of Hologic’s interventional breast solutions business. "Now, with MammoSite ML, five-day targeted radiation therapy is also available to women with early-stage tumors close to the skin or chest wall who may not have been good candidates for traditional balloon brachytherapy. This is another significant milestone for Hologic and our interventional breast solutions business. With FDA clearance of the MammoSite ML radiation therapy system, we are now able to provide surgeons and radiation oncologists with a device designed to both maximize patient comfort and enable greater physician flexibility in delivering targeted radiation therapy directly to the areas where breast cancers are most likely to recur."

Visit www.mammosite.com for additional information.

 

Related Articles Read More >

Lazurite ArthroFree wireless surgical camera system Minnetronix Medical
How Minnetronix Medical helped Lazurite with its wireless surgical camera
Medtronic Hugo robot-assisted surgery system
The road to a robot: Medtronic’s development process for its Hugo RAS system
A portrait of Stryker executive Siddarth Satish
How Stryker includes users for product design in the digital age
A portrait of Stryker executive Tracy Robertson
Stryker leaders talk medtech trends at DeviceTalks Boston: ‘If you’re slow, you’re going to lose’

DeviceTalks Weekly.

May 20, 2022
DeviceTalks Boston Post-Game – Editors’ Top Moments, Insulet’s Eric Benjamin on future of Omnipod 5
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech