7th April 2009
First Adiana®, Permanent Contraception System Performed in the UK At St John’s Hospital, Chelmsford, Essex
Fast, effective, non-incisional next-generation NEW permanent female sterilisation procedure that can be performed in an outpatient setting – soft insert smaller than a grain of rice
24th March 2009 marked the very first Adiana®, Permanent Contraception procedures to be performed in the UK by Mr Phil Robarts, Consultant Obstetrician and Gynaecologist at St John’s Hospital in Chelmsford, Essex.
Following the CE marking approval for the Adiana Permanent Contraception System that was granted in December 2008 to Hologic (www.hologic.com) a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products for women’s healthcare, 12 hospitals and 16 consultants have been trained to use the system in the UK. It was Mr Robarts who was the first consultant to perform the very first procedures outside of a clinical trial setting.
The Adiana procedure is a new, next-generation minimally invasive hysteroscopic procedure that can be performed under local anaesthesia in a hospital or clinic setting. It is a non-incisional alternative to traditional, surgical means of female sterilisation and 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.
Mr Robarts performed three Adiana procedures under general anaesthetic and commented afterwards, “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 at St John’s Hospital. 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. I am looking forward to doing many more Adiana procedures.”
Mr Robarts anticipates that up to 500 Adiana procedures will be performed over a year by the eight consultant obstetricians and gynaecologists at the Hospital and they are already looking at establishing Adiana as an outpatient procedure at St John’s.
37-year-old Natalie was Mr Robart’s very first Adiana patient. She was absolutely elated after the procedure and said, “When I found out about Adiana being piloted by Mr Robarts I had no second thoughts. I am unable to take oral contraceptives and this option was the perfect choice for me. I think it’s fantastic! I was expecting more discomfort but just feel a mild ache at the moment. I work from home as a travel counselor so will probably be back at my desk tomorrow!”
Mr Robart’s second patient, Lucy, agreed, “I’m 42 and have two lovely boys. Like Natalie I am unable to take oral contraceptives and I asked my GP about sterilisation and he referred me to Mr Robarts. Apart from some mild stomach cramps, I feel absolutely fine and can’t believe how quick it all was! Anything that doesn’t inhibit your lifestyle afterwards has to be a good thing.”
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 recognised 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.”
“Hysteroscopic sterilisation gives women another choice in permanent sterilisation,” adds Andrew Baxter, MRCOG, consultant, honorary senior lecturer, Department of Obstetrics and Gynaecology, The Royal Hallamshire Hospital, Sheffield, UK. Mr. Baxter has been performing hysteroscopic sterilisations 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.”
www.adiana.co.uk
ENDS
Media contact : Jo Triggs tel: (01245) 514235 | Mobile : 0790 005 4948
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