Hologic

…the company who have produced the newest innovation for female sterilisation: Adiana® Permanent Contraception, Huntleigh Healthcare – Diagnostic Products Divisio

Q: What are the major advantages of the Adiana® Permanent Contraception System versus traditional surgical means of female sterilisation?

A: The Adiana System is designed to provide a minimally-invasive, non-incisional alternative to traditional, surgical means of female sterilisation. The Adiana procedure utilises hysteroscopy, generally requires only local anaesthesia, and can be performed in an outpatient setting. Patients are normally able to return to work or resume their everyday activities within a day. In contrast, bilateral tubal ligation is typically performed in a hospital operating room under general anaesthesia and requires the physician to make one or two incisions in the abdomen. This usually requires approximately four to five days of recuperation.

Q: How does the Adiana System work?

A: The system enables a novel, two-step approach to permanent contraception. First, a catheter is positioned immediately inside the opening of the patient’s fallopian tube using a hysteroscope, eliminating the need for any incisions. The catheter applies a very low-level of bi-polar radiofrequency (RF) energy to remove just a thin layer of cells that line the inside of the fallopian tube. The catheter then delivers a small, inert polymer implant, called a “matrix,” which remains within the prepared section of the tube. The procedure is then repeated on the other fallopian tube. The procedure is designed so that healthy tissue will grow into the matrix to create a complete blockage of each tube. A confirmatory hysterosalpingogram (HSG) dye test is conducted at three months post-procedure to ensure the fallopian tubes are completely blocked and that the woman can begin relying on Adiana for permanent contraception.

Q: With CE marking approved, where were the safety and effectiveness studies for the Adiana System performed?

A: The Adiana Pivotal Trial (“A 12-Month Prospective Evaluation of Transcervical Sterilisation Using implantable Matrices’’ Vancaillie, Anderson and Johns) was published in the December edition of Obstetrics and Gynaecology, the Journal of the American College of Obstetrics and Gynaecology. This prospective multicentre study enrolled 770 women to evaluate Adiana’s performance with 1-year follow-up and was the basis for clinical submissions for both the CE Marking and the Food and Drug Administration (FDA) in the United States. The procedure showed a strong safety profile, with very high device placement success, patient tolerance, comfort, and satisfaction. Adiana was also found to be an easy and quick procedure that is well-suited as an outpatient procedure with comparable efficacy to other sterilisation methods. The National Institute for Clinical Excellence (NICE) subsequently updated their Hysteroscopic Sterilisation Guidelines (IPG315) in September this year which now includes Adiana Permanent Contraception. This has helped to increase the awareness and interest towards minimally invasive techniques for female sterilisation.

Q: How many Consultants have been trained to perform the Adiana procedure?

A: Following CE marking (January 2009) and FDA approval (July 2009) we have received significant interest in Adiana and to date over 400 consultants have completed the official didactic training programme. Mr Phil Robarts from St John’s Hospital in Chelmsford, Essex was the first consultant to perform the Adiana procedure outside of a clinical trial setting and he commented: “I believe Adiana is an eminently sensible and safe option for women who wish to be sterilised and I’m delighted to be able to offer Adiana as an effective sterilisation method for women. Ideally the procedure is accomplished in an outpatient setting, but if it is performed under general anaesthetic it still avoids the risks and discomfort associated with laparoscopic methods.”

Q: What are the synergies between Hologic’s NovaSure® Endometrial Ablation System for excessive menstrual bleeding and the Adiana®, Permanent Contraception System?

A: With the market approval of the Adiana System, Hologic is in the unique position of being able to provide European physicians with non-hormonal, minimally-invasive therapies that address two significant issues for women in their post-childbearing years: contraception and heavy menstrual bleeding. Currently NovaSure may be performed after confirming occlusion three months post the Adiana procedure. Both products will be sold using the same sales force and marketed through the same channels.

Q: Does Hologic produce any other products?

A: Yes. Hologic actually holds the number one position in nine technology areas serving women’s health. Hologic is a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products and our 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.

Q: Where can Hologic be contacted for further information?

A: Our UK Head Office is based in Crawley, West Sussex. We can be contacted by calling 01293 522080 or visiting our company website at: www.hologic.com. Specific information on Adiana can be found at: www.adiana.co.uk

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