Channel Medsystems announced that the Food and Drug Administration (FDA) has approved the Cerene Cryotherapy Device for the treatment of heavy menstrual bleeding. Specifically, it is indicated for endometrial cryoablation in premenopausal women with heavy menstrual bleeding due to benign causes for whom child bearing is complete.
Through cryotherapy, the Cerene Device freezes the uterine lining to significantly reduce menstrual bleeding. The procedure takes 2.5 minutes and can be done in the gynecologist’s office without anesthesia.
The device approval was based on data from the CLARITY study (N=242). Results at month 12 showed a reduction in menstrual bleeding that exceeded the objective performance goal; study success rate, defined as a Pictorial Blood Loss Assessment Chart (PBLAC) score of ≤75, was 76.9%. Patients’ median pain scores ranged from 0 to 2 (on a 0 to 10 scale) for 8 different peri-procedural time points. Moreover, no patients required general anesthesia. Hysteroscopies performed 1 year out further showed an accessible uterine cavity in 98.7% of available patients (N=223). With regard to quality of life, 95.7% of patients who were administered the Menorrhagia Impact Questionnaire at baseline and follow-up (N=112) reported a meaningful improvement in blood loss.
As for safety, no serious adverse events were reported. The most common adverse events included uterine cramping, bacterial vaginosis, and presyncope (vasovagal) symptoms; these were most likely to occur within 2 weeks of the procedure.
“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. 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,” stated Ric Cote, President and Chief Executive Officer of Channel Medsystems.
Alternative treatments for heavy menstrual bleeding include drug therapy (i.e., oral contraceptives, progesterone, danocrine, tranexemic acid, NSAIDs), which is typically a first-line approach, dilation and curettage, hysteroscopic endometrial ablation, second generation global endometrial ablation, and hysterectomy.
For more information visit ChannelMedsystems.com.