Cerene cryotherapy device for Endometrial ablation cleared for European market

ChannelMedsystems, the makers of Cerene cryotherapy endometrial ablation device today won the CE mark approval in the European union. The company is based at San Francisco, California, and the device is designed to treat premenopausal women with heavy menstrual bleeding who do not desire further pregnancies.

The Cerene Cryotherapy Device uses nitrous oxide, that freezes and destroy the surrounding endometrial tissue, thereby reducing scarring and intrauterine adhesions that are often associated with heat-based treatments.

Scarring and adhesions often lead to failure of procedure and reoperation. The cryothermic delivery system was incorporated into disposable, ergonomic device that can be held by hands thereby eliminating bulky equipments.

Earlier, in March 2017, Channel Medsystems, announced the successful completion of the treatment phase in its CLARITY Pivotal Study. The pivotal study evaluated the safety and efficacy of Cerene® Cryotherapy Device in 242 women with heavy menstrual bleeding who have already completed the family.

Ric Cote, President and CEO of Channel Medsystems said in a newsletter, ““From inception, our team has worked to understand what women and gynecologists are seeking in a new treatment for heavy menstrual bleeding. We’ve integrated that feedback into our development process and are excited that women in Europe will now have access to a treatment that is intended to meet their unique needs.”

“The introduction of the Cerene procedure in Europe will allow gynecologists to provide a new treatment option to their patients, one that may become more routine because it is designed to be more comfortable than traditional endometrial ablations, even without IV sedation or general anesthesia,” he further added.

Channel Medsystems endometrial cryoablation procedure animation video