Technology | July 08, 2009

Hologic Get PMA for Minimally-Invasive Permanent Contraception

July 7, 2009 - The U.S. Food and Drug Administration (FDA) has approved Hologic Inc.'s premarket approval (PMA) application for the Adiana permanent contraception system.

The Adiana system is designed to provide women a minimally-invasive, non-incision alternative to traditional, surgical means of permanent contraception. In January 2009, Hologic received CE marking approval for the Adiana system and commenced marketing and sales of this product in certain European countries.

During the Adiana procedure, a slender, flexible instrument is passed through the body’s natural openings to deliver a low level of radiofrequency (RF) energy to a small section of each fallopian tube. A tiny, soft insert, about the size of a grain of rice, is then placed in each fallopian tube in the location where the energy was applied. During the three months following the procedure, the patient continues to use
temporary birth control while new tissue grows in and around the Adiana inserts, eventually blocking the fallopian tubes. At three months, a special X-ray test (called a hysterosalpingogram or HSG) is performed
to confirm the fallopian tubes are completely blocked and the patient may begin relying on Adiana for permanent contraception.

The Adiana permanent contraception procedure is minimally invasive, requires no incisions and can be performed in the comfort of the doctor’s office using local anesthesia. Patients are normally able to return to work or resume their daily activities within one day. In contrast, traditional methods of permanent contraception, such as tubal ligation, require more invasive surgical procedures, usually are conducted in a hospital under general anesthesia and typically require four to five days of recovery. As a result, these more invasive surgical procedures can pose serious risk of complications, including anesthesia-related problems and damage to organs or blood vessels. There were approximately 70,000 female transcervical contraception procedures performed in the U.S. last year.1

For more information: www.hologic.com

Related Content

Clinical Data Supports Use of Xoft System for Endometrial Cancer
News | Brachytherapy Systems | August 03, 2017
Researchers presented clinical data supporting use of the Xoft Axxent Electronic Brachytherapy (eBx) System for the...
The ASPIRE Cristalle FFDM system with DBT combines Fujifilm’s state-of-the-art hexagonal close pattern (HCP) detector design, advanced image processing and image acquisition workflow
News | Women's Health | August 01, 2017
Fujifilm Medical Systems U.S.A., Inc. announced that The Mammography Center of Monterey, an ACR-accredited breast...
Sponsored Content | Videos | Breast Imaging | July 28, 2017
Nancy Cappello, Ph.D., executive director and founder of Are You Dense Inc. and Are You Dense Advocacy, explains how
Radiotherapy Prior to Surgery Reduces Secondary Tumor Risk in Early-Stage Breast Cancer Patients
News | Radiation Therapy | July 24, 2017
Moffitt Cancer Center researchers launched a first-of-its-kind study comparing the long-term benefits of radiation...
X-ray performed on a GE Optima 646 DR system. The FDA has updated its radiology reporting forms on its website.
News | Business | July 24, 2017
July 24, 2017 — The U.S.
Kubtec Launches New Website For Digital Imaging and Irradiation Products
News | Digital Radiography (DR) | July 20, 2017
Kubtec announced the launch a new website focused on the applications of digital X-ray imaging and irradiation for...
Volpara Solutions to Showcase Volpara Enterprise DDP Software at AHRA 2017
News | Mammography | July 11, 2017
Volpara Solutions Inc. will showcase its new Volpara Enterprise DDP software at the Association for Medical Imaging...
Agfa HealthCare Previews New DR 800 Imaging System at AHRA 2017
News | Digital Radiography (DR) | July 11, 2017
July 11, 2017 — Agfa HealthCare will display the new DR 800 Multi-Purpose Digital Imaging System with MUSICA for dyna
Canon and Virtual Imaging Inc. Showcase Newest DR Technologies at AHRA 2017
News | Digital Radiography (DR) | July 07, 2017
July 7, 2017 — Canon U.S.A. Inc. and Virtual Imaging Inc., a wholly owned subsidiary of Canon U.S.A.
Fujifilm Showcases Digital Radiography, Mammography Innovations at AHRA 2017
News | Digital Radiography (DR) | July 06, 2017
Fujifilm Medical Systems U.S.A. Inc. will present its comprehensive portfolio of digital radiography (DR) and...
Overlay Init