BEDFORD, Mass., Jan. 6, 2009 /PRNewswire/ -- Hologic, Inc. (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 that it has received CE marking approval for its Adiana® permanent contraception system. The Adiana system is designed to provide a minimally-invasive, non-incisional alternative to traditional, surgical means of female sterilization.
The Adiana procedure utilizes hysteroscopy, generally requires only local anesthesia, and can be performed in a physician's office. Patients are normally able to return to work or resume their everyday activities within a day. In contrast, bilateral tubal ligation - commonly referred to as "getting your tubes tied" - is typically performed in a hospital operating room under general anesthesia and requires the physician to make one or two incisions in the abdomen. This usually requires approximately four to five days of recuperation.
CE marking approval allows Hologic to market the Adiana system in the 27 countries of the European Union (EU) and three of the four member states of the European Free Trade Association (EFTA). CE marking is recognized in many countries outside the European Economic Area giving Hologic the ability to supply systems to a number of markets internationally. In the United States, the pre-market approval (PMA) application for the Adiana permanent contraception system is currently under Food and Drug Administration (FDA) review. Hologic is also in the process of registering the Adiana system in Canada and Australia.
"This is another significant milestone for Hologic and our GYN surgical products business," said Tony Kingsley, senior vice president and general manager, Hologic GYN surgical products. "Europe is a key area of growth for us and where we have a formidable sales and marketing infrastructure in place and solid support from key opinion leaders. The Adiana permanent contraception system offers a novel approach to permanent contraception and is designed to provide several advantages over existing non-incisional methods, including ease of use for the physician, which can result in more safe and successful procedures for the patient."
"Transcervical methods of female sterilization offer significant advantages compared to traditional laparoscopic approaches," notes gynecologist Sebastiaan Veersema, M.D., of St. Antonius Hospital, Nieuwegein in The Netherlands. "The availability of alternative, reliable sterilization devices will improve women's choice when considering methods available to them as they seek permanent contraception."
"Hysteroscopic sterilization gives women another choice in permanent sterilization," adds Andrew Baxter, MRCOG, consultant, honorary senior lecturer, Department of Obstetrics and Gynecology, The Royal Hallamshire Hospital, Sheffield, UK. Mr. Baxter has been performing hysteroscopic sterilizations for the last six years. "It also allows them to avoid hospital admission, anaesthetic and the discomfort and risks attached to laparoscopy (a keyhole examination of the abdomen). We find that our patients can go home after half an hour and are back to normal within a couple of days. Patient satisfaction levels are very high. The Adiana system is a new technique to the UK which we hope will allow more women to have access to this exciting procedure."
About Hologic, Inc.
Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women. Hologic's core business units are focused on breast health, diagnostics, GYN surgical, and skeletal health. Hologic provides a comprehensive suite of technologies with products for mammography and breast biopsy, radiation treatment for early-stage breast cancer, cervical cancer screening, treatment for menorrhagia, osteoporosis assessment, preterm birth risk assessment, mini C-arm for extremity imaging and molecular diagnostic products including reagents for a variety of DNA and RNA analysis applications.
Forward Looking Disclaimer
This News Release may contain forward-looking information that involves risks and uncertainties, including statements about the effect and adoption of the use of the Adiana system. There can be no assurance that the system will achieve the benefits described herein and that such benefits will be replicated in any particular manner with respect to an individual patient as the actual effect of the use of the Adiana system can only be determined on a case-by-case basis depending on the particular circumstances of the procedure and patient in question. Thus there can be no assurance of general adoption of this technology by the medical community. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to the data or statements presented herein to reflect any change in Hologic's expectations or any change in events, conditions or circumstances on which any such data or statements are based. Certain factors that could adversely affect Hologic's business and prospects are described in Hologic's filings with the Securities and Exchange Commission.
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