FDA Approves Cerene Cryotherapy Device for Heavy Menstrual Bleeding

APRIL 02, 2019
Cecilia Pessoa Gingerich
FDA, The US Food and Drug Administration (FDA) has approved the Cerene Cryotherapy Device for treating heavy menstrual bleeding in premenopausal women who are not planning to become pregnant. The device uses cryotherapy to freeze the endometrial lining of the uterus to reduce future menstrual bleeding.

In comparison to endometrial ablation using heat, which is often performed with general anesthesia in hospitals or surgery centers, ablation using the Cerene Device does not require general anesthesia and can be performed in a gynecologist’s office.

"The Cerene Device provides gynecologists with the first realistic option for treatment in their office, a setting that is more comfortable for women and significantly less expensive for the healthcare system,” said Ric Cote, President and Chief Executive Officer of Channel Medsystems. “The shift away from the operating room that the Cerene Device enables could potentially reduce the cost to treat heavy menstrual bleeding by hundreds of millions of dollars annually.”

The FDA’s decision to approve the cryotherapy device was supported by data from the pivotal CLARITY study. The open-label, single group study evaluated the safety and efficacy of the Cerene Device in 242 female participants, ages 25 to 50 years,

The study reported that patient’s pain rating varied from 0 to 2 at various points during and after the procedure on a 0 to 10 pain scale. No patients required general anesthesia.

At 12 months after the cryotherapy procedure, an accessible uterine cavity was confirmed in 98.7% of 223 participants that were available for follow-up. This result was a “critical finding that allows for diagnostic evaluation including sampling of the endometrium rather than forcing hysterectomy because of unevaluable post-ablation bleeding and/or pain," said investigator Ted Anderson, MD, PhD, Vice Chair of Clinical Affairs and Director of the Division of Gynecology at Vanderbilt University Medical Center.

The study also reported a reduction in menstrual bleeding at 12 months that surpassed treatment goals.

“Women who suffer from heavy menstrual bleeding are seeking safe and effective treatments that are well tolerated with minimal inconvenience,” said Anderson. “Channel Medsystems has developed a treatment that is easy to use, is reproducible in any setting of care, and is very well tolerated without anesthesia."

The Channel Medsystems survey Cote referenced polled over 450 gynecologists. Large numbers of the providers surveyed indicated that they would recommend endometrial ablation more often if perioperative pain were mitigated (81%) and if clinically-significant intrauterine adhesions were reduced (79%).

"We are extremely pleased by the results of the CLARITY study and the positive feedback we have received about the Cerene Device, both from study investigators and numerous gynecologists surveyed," added Cote.

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