Adiana system offers safe, simple, effective alternative to tubal ligation
BEDFORD, Mass., July 7 /PRNewswire-FirstCall/ -- Hologic, Inc., (Hologic or the Company) (Nasdaq: HOLX), a leading 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) has approved the Company's premarket approval (PMA) application for the Adiana(R) 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. In addition to this News Release, please view the Multimedia News Release related to the Adiana system at: http://www.prnewswire.com/mnr/adiana/38601.
To view the Multimedia News Release, go to: http://www.prnewswire.com/mnr/adiana/38601/
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)
'While tubal ligation is the most common form of permanent contraception used throughout the world, hysteroscopic procedures such as those employing the Adiana permanent contraception system enable women to choose lifetime protection from pregnancy without the risks of general anesthesia and the longer recovery periods associated with traditional sterilization procedures,' said Ted Anderson, M.D., Ph.D., associate professor of obstetrics and gynecology at Vanderbilt University, and clinical investigator of the pivotal clinical trial for the Adiana system.