Shots:
- The FDA has granted IDE approval to initiate a multi-center pivotal study evaluating the Separo Vessel Sealing System vs standard mucosal cautery vasectomy
- The trial will enroll 120 adult male subjects across ~5 US centers, with the primary endpoint measuring azoospermia or rare non-motile sperm (≤100,000/mL) within 6mos. following the procedure
- The Separo System is an energy-based vessel sealing platform designed specifically for vasectomy, with the pivotal study intended to generate evidence supporting future regulatory clearance, clinical guideline inclusion, & reimbursement adoption
Ref: Globenewswire| Image: Signati Medical|Press Release
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