The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee met on January 29, 2001 to discuss a premarket approval application (PMA P000032) from Cryogen, Inc. for their FirstOptionÔ Uterine CryoblationÔ Therapy System. This device is indicated for abnormal uterine bleeding due to benign causes in premenopausal women for whom childbearing is complete.
The panel considered the sponsor’s prospective, randomized, controlled, blinded clinical trial in which 189 women were treated with FirstOptionÔ and 86 women were treated with rollerball endometrial ablation (REA). The study design conformed to the recommendations in FDA’s guidance on devices used to perform endometrial ablation. The study design required women enrolled in the study to be followed for a total of three years post-procedure (twelve months premarket and an additional two years postmarket). The definition of success in reducing menstrual flow was a reduction in pictorial blood assessment chart (PBAC) score from >150 to <75. Because a statistical difference of up to 20% between study arms was considered clinically acceptable, the study was deemed to have met its hypothesis if the upper bound of the two-sided 95% confidence interval on the difference between REA and FirstOptionÔ was <20%. Intent-to-treat success rates for FirstOptionÔ were 68.4% and 73.5% for REA, with an upper bound on the 95% confidence interval of 16.9%; evaluable success rates were 74.0% and 81.3%, respectively, with an upper bound on the 95% confidence interval of 18.4%. Therefore, the sponsor met their hypothesis.
The panel voted 9-0 that the PMA was approvable with the following conditions:
- The sponsor should conduct a prospective premarket study to demonstrate that the device malfunction rate of 26.5% has been reduced to an acceptable level.
- The sponsor should standardize and carefully document the procedure in their labeling.
- The sponsor should conduct a postmarket analysis of this standardized technique using six months followup PBAC scores to further evaluate the variability of success rates encountered in the pivotal clinical trial.
- The sponsor should revise the indication to specifically state that the device is for the reduction of bleeding.
- The sponsor should revise the physician and patient labeling in accordance with the panel discussion to FDA’s satisfaction.
Contact: Elisa Harvey, Ph.D., Executive Secretary, 301-594-1180, 141
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