The AEGEA Vapor System is the first endometrial ablation system specifically designed to be used in the doctor’s office.

Technology Overview

The AEGEA Vapor System

The AEGEA Vapor System is indicated to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia due to benign causes for whom childbearing is complete. The AEGEA Vapor System uses adaptive vapor ablation technology to gently fill the uterine cavity with natural water vapor.

Physical Components of the AEGEA Vapor System

The AEGEA Vapor System consists of:

  1. The Vapor Generator
    The AEGEA Vapor Generator is reusable and completes an automated self-sterilization cycle of the vapor path prior to each patient use.
  2. Single-Use AEGEA Vapor Procedure Kit
    Each single-use AEGEA Vapor Procedure Kit includes:
    • a sterile AEGEA Vapor Probe with a soft flexible tip to ease insertion.
    • a Supply and Drain Accessory that delivers water to, and collects water from, the Vapor Generator

Safety Features of the AEGEA Vapor System

The AEGEA Vapor System uses a slender Vapor Probe, SmartSealTM technology and the IntegrityProTM safety feature to protect the cervix and vagina from thermal effects.

Slender, Flexible Vapor Probe
  • The slender Vapor Probe is used to deliver the sterile water vapor into the uterine cavity.
  • Provides a soft, flexible tip for insertion through the internal os
  • Includes a cervical collar designed to aid in placing the Vapor Probe just beyond the internal cervical os
  • Designed to eliminate any requirements to touch the uterine fundus
  • Does not require cervical dilation
SmartSealTM
  • SmartSeal™ is the combination of the triple balloon cervical sealing system, automated real-time intrauterine vapor pressure regulation and monitoring to maintain a low intrauterine pressure of 20 mmHg to 52 mmHg. It also monitors the cervical canal temperature via the thermocouple placed on the middle sealing balloon
  • Provides automated real-time pressure monitoring with active management of uterine and cervical seal
  • Monitors balloon pressure, uterine pressure and cervical temperature and is designed to confine vapor to the uterine cavity during treatment.
  • Redundant cervical sealing: triple balloon plus cervical thermocouple
IntegrityProTM
  • IntegrityPro™ includes a new, patented secondary safety check that is above and beyond the integrity test to provide an added level of confidence.
  • Uses SmartSeal™ to confirm vapor is confined to the uterine cavity.
  • Integrity test uniquely includes confirmation of correct placement of the device.
  • Safety checks must be successfully completed consecutively before delivery of vapor can be initiated.
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