For the test to be conducted properly, the HSG operator should advance the contrast media beyond the cornua into the fallopian tube to the location of the Adiana considering matrix (Figure 3).17 Figure 3 Implanted matrix location and image depicting contrast media filling the proximal tube. Commercial Use Adiana was first made commercially available in January 2009 for hysteroscopic sterilization procedures in Europe, and was subsequently approved by the FDA in July 2009. In 2010, the Adiana product instructions for use (IFU) were revised to allow the device to be used in women 6 weeks after a pregnancy. Worldwide adoption of the procedure has been rapid. Physicians interested in using the Adiana device complete didactic, surgical, and practical training on both the surgical procedure and the HSG confirmation test prior to purchasing the device or controller.

Through June 30, 2010, approximately 6334 units (2 devices/unit for bilateral sterilization) were shipped to physicians trained to use the Adiana device.19 In July 2010, a project was initiated to assess physician experience with the training programs and clinical performance of the Adiana product. All US-based surgeons who have completed the Adiana training program were sent an invitation to participate in an online survey. Information was collected to evaluate Adiana��s clinical performance characteristics, including bilateral placement rate, compliance with HSG, and the observed rate of tubal occlusion. A secondary aim of the survey was to gather information on pregnancies among patients with Adiana implants.

This information was used in part to calculate a commercial-use efficacy rate. Of the 337 clinicians registered in the database, 168 (49.9%) responded to the e-mail request and 156 (46.3%) completed the survey. The responses represent the experience of approximately 1500 cases. Bilateral occlusion rates were high; 80% of physicians responding to the survey reported 3-month bilateral occlusion rates in excess of 85%. Unilateral and inconclusive results were found to occur very infrequently and were reported to occur less than 5% of the time (Hologic, unpublished data). These rates of occlusion are consistent with those observed in the EASE trial.8 Using the number of reported pregnancies and commercial units sold adjusted for utilization and the timeline imposed by the HSG procedure, a statistical model was developed to provide an estimate of efficacy in the commercial-use population.

This rate was compared with the 12-month efficacy rate reported Anacetrapib in the EASE trial.8 This method permits an estimation of the 1-year probability of pregnancy, although many women in the commercial-use population have been relying on the Adiana system for less than 12 months. Based on industry experience, an assumption was made that, conservatively, 75% of the monthly shipped devices are used in surgery that month; this translates to approximately 4750 procedures performed during this 18-month time period.