The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee met on June 3, 2004, in an open session.
The panel discussed the pre-market approval application (PMA P040003) from InSightec, Ltd. for the ExAblate® 2000. The ExAblate® 2000 is intended for use in pre- or peri-menopausal women with symptomatic uterine fibroids.
The panel considered the sponsor’s non-randomized, prospective, two arm pivotal clinical trial in which 109 patients were treated with the ExAblate® 2000, and 83 patients in the control arm had abdominal hysterectomies. At 6 months, 77 of the 109 patients (70.6%; 95% confidence interval [61.2%, 79.0%]) treated with the ExAblate® 2000 had at least 10-point improvements in their score on the Symptom Severity Scale of the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL). The panel also considered adverse events, which included 5 patients in the pivotal trial who experienced nerve injury lasting from 2 days to 12 months.
The panel voted 8-5 that the PMA was approvable with the following conditions:
- The sponsor should provide analysis of data on uterine volumes and possible correlation with treatment failure.
- The sponsor and FDA should develop a strategy for assessing the impact of this procedure on future pregnancy; one suggestion was a registry.
- Physician labeling should prominently indicate how to minimize the risk of nerve injury. Patient labeling should explicitly indicate the possibility of nerve damage.
- Physician labeling should include additional description of training, including classroom time and phantom laboratory practice.
- Physician labeling should include additional information on the primary endpoint of the pivotal study and up-to-date references on the UFS-QOL.
- Physician labeling should include information on scars in the treatment area and the possible impact of previous Cesarean section. Data about the impact of previous Cesarean section should be obtained from the clinical study.
- Physician labeling should indicate the importance of the level of patient sedation and the need to maintain continuous communication with the patient to reduce the risk of nerve injury.
Contact: Joyce M. Whang, Ph.D., Executive Secretary, 301-594-1180, x127
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