05/01/2009

FDA approves Hologic’s Adiana permanent contraception system

By AMANDA PEDERSEN - Medical Device Daily Staff Writer

May 1, 2009 -- Women looking for permanent protection from pregnancy now have a less invasive option than getting their tubes tied. Hologic (Bedford, Massachusetts), a developer of diagnostics, medical imaging systems and surgical products intended to serve the healthcare needs of women, said the FDA has approved its premarket approval 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 the company received a CE mark for the system and began marketing and sales of the device in certain European countries (Medical Device Daily, Jan. 8, 2009).

According to Hologic, the Adiana permanent contraception procedure is minimally invasive, requires no incisions and can be performed in the doctor’s office using local anesthesia. Patients are normally able to return to work or resume their daily activities within one day, the company said. 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 roughly 70,000 female transcervical contraception procedures performed in the U.S. last year, Hologic said.

“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, MD, PhD, associate professor of obstetrics and gynecology at Vanderbilt University (Nashville, Tennessee), and clinical investigator of the pivotal clinical trial for the Adiana system. “The Adiana procedure is a safe and simple alternative that not only provides patients with peace of mind in preventing pregnancy, but also leaves nothing in the uterus that might limit women’s options for future gynecologic tests and procedures.”

Tony Kingsley, senior VP of GYN surgical products at Hologic, told Medical Device Daily in an email that permanent contraception can provide relief from the concerns of the widely-used reversible methods, including a greater risk of failure, the inconvenience of interrupting relations, hassle of continual re-supply, and unavoidable hormonal or product related side-effects. He said the Adiana procedure eliminates the burden of taking daily pills, the hassle of continual resupply, as well as the hormonal side effects associated with oral contraceptives (including abdominal pain, acne, back pain, weight gain, breast tenderness and moodiness). It does not use drugs or hormones that can disrupt a patient’s menstrual cycle or affect her natural body chemistry, Kingsley added. It also leaves nothing in the uterus and contains no material that can create allergic reactions. The Adiana inserts are completely contained inside the fallopian tubes, leaving nothing behind in the uterus that may limit a patient’s options for future diagnostic or therapeutic procedures. According to Kingsley, the product’s name – pronounced “Ahh-dee-ahna” – literally means “against fertility.”

“Adiana is a ‘woman’s idea’ of contraception, we wanted to give it a feminine name,” Kingsley said.

The Adiana procedure is indicated for women who desire permanent birth control by occlusion of the fallopian tubes. Ideal candidates include women who do not want children in the future and would like the peace of mind and convenience of permanent birth control. The procedure may also be an ideal solution for women who desire permanent birth control but are poor candidates for surgery, the company noted.

“Many women seek relief from the uncertainty and hassle of temporary birth control methods once they know their childbearing is complete. However, few know that permanent contraception is available without incisions, the use of general anesthesia, or need for lengthy hospital stays,” Kingsley said. “With the Adiana permanent contraception system, we are very excited to be able to offer these women a new alternative for their long-term contraception needs.” During the Adiana procedure, a slender, flexible instrument is passed through the body’s natural openings to deliver a low level of radio frequency 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 is performed to confirm the fallopian tubes are completely blocked and the patient may begin relying on Adiana for permanent contraception.

According to the company, the procedure has been studied in women ages 18 to 45. “This is another significant milestone for Hologic and our GYN surgical products business,” Kingsley said. “With FDA approval of the Adiana system, we are now able to provide physicians with another non-hormone, minimallyinvasive therapy that addresses a significant issue for women in their post-childbearing years.”

Earlier this year Conceptus (Mountain View, California), developer of the Essure procedure, filed a lawsuit in U.S. District Court for the Northern District of California against Hologic seeking a declaration by the court that the sale of the Adiana system would infringe several U.S. patents owned by Conceptus. Conceptus said at the time it was seeking an injunction prohibiting Hologic from importing, using, selling or offering to sell its Adiana system in the U.S. (MDD, May 27, 2009).

The Essure procedure is also a permanent birth control method that can be done in a doctor’s office in about 13 minutes without hormones, cutting, burning or the risks associated with general anesthesia or tubal ligation, according to Conceptus. With that procedure, small, flexible micro-inserts are placed in the woman’s fallopian tubes through the cervix without incisions. Over the next three months, the body forms a natural barrier around the micro-inserts to prevent sperm from reaching the egg. Essure was FDA-approved in 2002.

Kingsley said that while the Adiana procedure is easy to learn and use, it should only be performed by physicians who have had prior training in hysteroscopy, have read and understood the instructions for use, and have completed the mandatory training program developed for the device.