Cryotherapy device to treat heavy menstrual bleedingJune 9, 2019
Cerene cryotherapy device has been granted approval by US FDA as a new approach to treating heavy menstrual bleeding.
The device uses cryotherapy to freeze the endometrial lining of the uterus to reduce future menstrual bleeding in premenopausal women who are not planning to become pregnant.
This procedure does not require general anaesthesia. It can, therefore, be performed in the gynaecologist’s office in contrast, heat-based endometrial ablation devices which are more often performed with general anaesthesia in hospitals.
CLARITY, the pivotal study supporting the safety and effectiveness of the Cerene device and its FDA approval included treatment of 242 subjects.
At 12 months, the observed reduction in menstrual bleeding exceeded treatment goals.