There are two cohorts to monitor safety in this study:~Cohort 1: The first 10 subjects will be reviewed for safety by a Data Safety Monitoring Board (DSMB) at 30 days post-implantation. The 10 subjects will then be followed up to 36 months or until the average of two semen analyses is ≥ 15 million sperm/mL (the duration between collection of both specimens is ≥2 days and ≤7 days).~Cohort 2: An additional 15 subjects will be enrolled and implanted with ADAM after the DSMB Safety Review of the first 10 subjects at 30 days. They will be followed up to 36 months or until the average of two semen analyses is ≥ 15 million sperm/mL (the duration between collection of both specimens is ≥2 days and ≤7 days).
This study will evaluate the safety and feasibility of the ADAM System for implantation into the vas deferens in 25 healthy males at 2 sites. This is a prospective, non-randomized, open label interventional trial.