Cerene Cryotherapy Device - P180032
This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Cerene® Cryotherapy Device
PMA Applicant: Channel Medsystems, Inc.
Address: 5858 Horton Street, Suite 200, Emeryville, CA 94608
Approval Date: March 28, 2019
Approval Letter: Approval Order
What is it? The Cerene® Cryotherapy Device is an endometrial ablation device that uses a freezing agent to destroy (ablate) the lining of the uterus (endometrium) to reduce heavy menstrual bleeding.
How does it work? A gynecologist uses the Cerene® Cryotherapy Device to ablate the endometrial lining of a woman's uterus and reduce heavy menstrual bleeding. The Cerene® Cryotherapy Device has a slim probe that the gynecologist inserts through the cervix and into the woman's uterus. Once inserted, a freezing agent is released, and the endometrial lining of the uterus is destroyed.
When is it used? The device is intended to be used in pre-menopausal women with heavy menstrual bleeding due to benign (non-cancerous) causes who do not want to become pregnant in the future.
What will it accomplish? The device destroys the endometrial lining of the uterus to reduce menstrual bleeding. In the pivotal clinical study, seventy-six percent (76%) of women observed a reduction in menstrual blood loss from an excessive level to normal or less than normal levels.
When should it not be used? The Cerene® Cryotherapy Device should not be used in women who:
- Are pregnant or want to become pregnant in the future. Pregnancies following ablation can be dangerous for both the mother and fetus.
- Have a known or suspected uterine cancer or pre-malignant conditions of the endometrium, such as unresolved adenomatous hyperplasia.
- Have any anatomic condition (e.g., history of previous classical (vertical) cesarean section or surgical removal of uterine fibroids (transmural myomectomy), whether hysteroscopic and/or laparoscopic, performed immediately prior to the Cerene® procedure) or pathologic condition (i.e., condition requiring long-term medical therapy) that could lead to weakening of the muscular outer layer of the uterus (myometrium).
- Have a history of endometrial ablation and/or resection (including endometrial ablation/resection performed immediately prior to the Cerene procedure), regardless of the way (modality) it was performed. Repeat ablation may result in serious patient injury.
- Have an active urinary tract infection or genital infection (e.g., cervicitis, vaginitis, endometritis, inflammation of the fallopian tubes (salpingitis), cystitis, pelvic inflammatory disease, or tubo-ovarian abscess) at the time of treatment.
- Have an intrauterine device (IUD) currently in place.
- Have undiagnosed vaginal bleeding.
Additional information (including warnings, precautions and adverse events):