Examine of Medtronic Hugo ™ Robotic-assisted surgical procedure system in Hernia restore meets security and effectiveness finish factors

Examine of Medtronic Hugo ™ Robotic-assisted surgical procedure system in Hernia restore meets security and effectiveness finish factors

September 5, 2025- Medtronic PLC introduced outcomes of the Allow Hernia Restore Medical Examine to analysis of the efficiency of the Hugo ™ Robotic-Assisted Surgical procedure (RAS) system in inguinal and ventral hernia restore procedures. Schakel Hernia Restore is the very first analysis equipment exemption (IDE) medical examine of the analysis by Robotic-Assisted Hernia surgical procedure in the USA. Finish factors of major security and effectiveness had been met, in help of the usage of the Hugo RAS system in Hernia restore procedures.

Allow Hernia Restore is a potential, multi-center, single-arm essential examine with 193 sufferers who underwent inguinal or ventral robot-like hernia restore with the Medtronic Hugo ™ RAS system. An important findings embrace:

  • The examine met the first effectiveness level:
    ̵ The surgical success charge Was 100percentand surpassed the pre -specified efficiency objective of 85%. (P <0.0001)
  • The examine met the first security finish level for each cohorts, which had been independently analyzed:
    ̵ Inguinal: in 92 sufferers out there for evaluation, the surgical location occasion (SSE) proportion was 0.0%, which is significantly decrease than, and assembly, the predetermined efficiency objective of 30% (p <0.0001).
    ̵ Ventral: in 94 sufferers out there for evaluation, the SSE pace was 2.1%, which is significantly decrease than, and a gathering, the predetermined efficiency objective of 30% (p <0.0001); Two SSEs had been registered and resolved with out complication.

Learn extra

Leave a Reply

Your email address will not be published. Required fields are marked *