Pregnancy rate is defined as the cumulative percentage of pregnancies occuring within the time frame. The primary endpoint for this study is the pregnancy prevention rate after one year of reliance on the Adiana System for pregnancy prevention. The pregnancy rate was evaluated for all participants who underwent successful bilateral treatment and who had demonstrated tubal occlusion by hysterosalpingogram (HSG) at the end of the Waiting Period.

645 participants had treatment attempted; Intent to Treat population. Of these 645, 570 were able to rely on the device and are used to evaluate the pregnancy prevention rate for the 1-year endpoint. During the 1-year follow-up period, there were 6 pregnancies, of which 3 were attributable to physician error, i.e., misinterpretation of HSG results.

Defined as successful bilateral tubal access followed by successful bilateral RF treatment and matrix placement.

Device placement rate reported on a per participant basis for 645 intent to treat participants. Successful bilateral placement of the matrices was achieved in 604/645 participants after the first procedure.

Defined as successful bilateral tubal access followed by successful bilateral RF treatment and matrix placement.

Device placement rate reported on a per participant basis for 645 intent to treat participants. Successful bilateral placement of the matrices was achieved in 611/645 participants after 7 participants underwent a successful second attempt.

Determined by verbal questions up to 48 hours post placement. Endpoint reported represents minimum percentage of participants reporting somewhat satisfied, satisfied or very satisfied.

Intent to treat population; no imputations for missing data. Minimum satisfaction reported as 605/625 participants.

Determined by verbal questions during periodic follow-up contacts. Endpoint reported represents minimum percentage of subjects reporting somewhat satisfied, satisfied or very satisfied.

Intent to treat population; no imputations for missing data. Minimum satisfaction reported at 2-Months as 587/613 participants.

Determined by verbal questions during periodic follow-up contacts. Endpoint reported represents minimum percentage of subjects reporting somewhat satisfied, satisfied or very satisfied.

Per protocol population; no imputations for missing data. Minimum satisfaction reported at 12-Months as 528/531 participants.

Determined by verbal questions two hours following procedure or at discharge from facility, whichever came first. Endpoint reported represents minimum percentage of participants reporting any discomfort or pain experienced during the procedure as the same as or less than they expected.

Intent to treat population; no imputations for missing data. Minimum comfort reported as 504/629 participants.

Determined by verbal questions up to 48 hours post placement. Endpoint reported represents minimum percentage of participants reporting any discomfort or pain experienced in first 48 hours following procedure as the same as they expected, less than they expected or no pain.

Intent to treat population; no imputations for missing data. Minimum comfort reported as 578/632 participants.

Determined by verbal questions during periodic follow-up contacts. Endpoint represents minimum percentage of subjects reporting good, very good or excellent comfort.

Intent to treat population; no imputations for missing data. Minimum comfort reported at 1-Month as 604/608 participants.

Determined by verbal questions during periodic follow-up contacts. Endpoint represents minimum percentage of subjects reporting good, very good or excellent comfort.

Per protocol population; no imputations for missing data. Minimum comfort reported at 12-Months as 530/532 participants.

Pregnancy rate is defined as the cumulative percentage of pregnancies occuring within the time frame. The pregnancy rate was evaluated for all participants who underwent successful bilateral treatment and who had demonstrated tubal occlusion by hysterosalpingogram (HSG) at the end of the Waiting Period who have been followed for up to 3 years.

Population includes all participants able to rely on Adiana (n=570). This analysis is cumulative and based on survival analysis methodology. Thus, participants only followed for 2 years, for example, would still be included in this cumulative analysis. In total, 481 participants were available with 3 years of follow-up at the time of analysis.