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Obstetrics and Gynecology Devices Panel - December 13-14, 2007

The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee met on December 13-14, 2007, in Gaithersburg, MD.

On December 13, 2007, the panel discussed the pre-market approval application (PMA P070022) from Hologic, Inc. ( Bedford, MA) for the Adiana Transcervical Sterilization System. The proposed Indication for Use for the Adiana Transcervical Sterilization System is “for women who desire permanent birth control (female sterilization) by occlusion of the fallopian tubes.”

The Adiana Transcervical Sterilization System consists of three principal components: the silicone matrix implant (one per tube), a hysteroscopic delivery catheter, and a radio-frequency (RF) generator. The delivery catheter is introduced into the patient through a hysteroscope, transvaginally and transcervically. Once placement inside the intramural section of the fallopian tube is confirmed, the distal tip of the catheter delivers RF energy, causing a lesion within the fallopian tube. After the thermal dose is delivered, the silicone matrix is deployed in the region of the tube where the lesion was formed. Occlusion is achieved by tissue ingrowth over the next few weeks into the silicone matrix. Occlusion of tubes is assessed by hysterosalpinography (HSG) three months after device placement.

The panel considered the sponsor’s pivotal study, which looked at the use of Adiana Transcervical Sterilization System for permanent birth control by occlusion of the fallopian tubes. The pivotal study was a prospective, single-armed, multi-center, international clinical trial conducted in the U.S., Australia, and Mexico. The pivotal trial had two phases: 1) the Waiting period after initial Adiana System treatment and, 2) the Wearing Follow-up Period post tubal occlusion determination. The Waiting Period was the time period between Matrix placement and the 3-month visit during which women were instructed to rely on alternative contraception method. At the 3-month Waiting visit, a HSG was performed to evaluate tubal occlusion. If the HSG evaluation was satisfactory, women were instructed to discontinue alternative contraception, subsequently entering the Wearing Follow-Up Period and relying only on the Adiana System for contraception. If the HSG was not satisfactory, women were given the option of waiting an additional 3 months for a second HSG. If the HSG demonstrated bilateral occlusion, women were allowed to rely on the device at that time. If there remained tubal patency, they were advised to seek alternative contraception. Women were scheduled for follow-up at 6, 9, 12, 18 months, and 2, 3, 4, and 5 years.

The primary endpoint for the pivotal study was pregnancy within the first 12 months of reliance on the Adiana System. The PMA contained a full data set from the first two years of wearing the device (table below), plus partial data sets for year-3 and year-4. Three of the six pregnancies in the first year were attributed to a misinterpretation of complete bilateral occlusion of the 3-month HSG, i.e., telling the patient to rely on the Adiana device even though the HSG indicated tubal patency.

Contraceptive Efficacy of Adiana Transcervical Sterilization System 

 

# of subjects 1

# of pregnancies

% pregnancies 2

95% confidence bound 3

Year 1

554

6

1.07%

2.1

Year 2

524

3

1.67%

2.9

Secondary endpoints included the device placement rate, patient satisfaction and comfort, and placement and wearing safety.

The panel voted 10-3 recommending approval of the PMA for the Adiana Transcervical Sterilization System, subject to the following six conditions:

  • Continue to follow initial cohort of patients from the pivotal study (n=570) out to 10-years;
  • Initiate new cohort (new women, new physicians) in postmarket setting and follow longitudinally to assess generalizability of results ("real world"). The endpoint of this study would be pregnancy events;
  • Provision in postapproval studies for histological analysis of explanted tissues in women who undergo hysterectomy ;
  • Conduct testing to assess device function following intentional fallopian tube perforation using an animal model;
  • Patient and professional labeling should include statements on uncertainty of long-term effectiveness and risks;
  • An active control group, preferably a transcervical method, should be included in the new patient cohort study (see #2 above).

On December 14, 2007, the panel heard a postapproval study update for the ExAblate 2000 System from InSightec, Inc. The system is indicated for ablation of uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure.

The panel also heard a discussion from FDA regarding clinical trial design issues for elective endometrial ablation to reduce or eliminate menstruation in pre-menopausal women for whom childbearing is complete. The FDA presented the panel with an overview of its regulatory concerns regarding study designs for devices for this Indication and presented the panel with nine discussion questions regarding such study designs, e.g., ethics, control groups, inclusion/exclusion criteria, contraindications, endpoints, length of follow-up, quality of life measurement, safety concerns, and device labeling.

Following the presentation by FDA, the panel heard presentations from device manufacturers and clinical investigators regarding the topic of discussion. After that, the panel addressed FDA’s nine discussion questions. The panel provided comments on clinical trial design, addressing elements of study population, outcome measures, controls, and length of follow-up. FDA will use this input to help guide manufacturers proposing Indication modifications for use of endometrial ablation devices for women seeking elective cessation of menses.

Contact: Michael T. Bailey, Ph.D., Executive Secretary, 240-276-4100

The transcripts may be purchased from: (written requests only)

Neal R. Gross & Company
1323 Rhode Island Avenue, NW
Washington , DC 20005
(202) 234-4433 (voice), (202) 387-7330 (fax)

Or

Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20851
(301) 827-6500 (voice), (301) 443-1726 (fax)