Channel Medsystems has earned a CE mark for its cryotherapy device for the treatment of excessive menstrual bleeding. The device uses extreme cold to destroy uterine tissue and alleviate symptoms.
While many women experience heavy menstrual bleeding, some women lose so much blood through menstruation that it interferes with their daily activities. This condition, called menorrhagia, has a range of treatments, from drugs or contraceptives to hysterectomy.
Endometrial ablation is an option for women who can’t undergo other treatments, or for whom other treatments have failed. The procedure usually uses heat to ablate, or destroy, the endometrial tissue that lines the uterus. But some systems, including Cooper Surgical’s Her Option, freeze the tissue to remove it.
Channel Medsystems’ Cerene Cryotherapy device is designed to use cryoablation to treat heavy menstrual bleeding in premenopausal women who do not intend to have children, the company said in a statement. It is an outpatient procedure.
While some endometrial ablation procedures, such as those using the Cerene device, may be done in a doctor’s office, other procedures must be done under anesthesia in an operating room.
"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,” said Dr. Mark Hans Emanuel, a gynecology specialist at the University Medical Center in Utrecht, Netherlands, in the statement.
Spun out of TheraNova, Emeryville, California-based Channel Medsystems will kick off marketing efforts in Europe. The company has just finished the treatment phase of a 242-patient pivotal study and is gathering data for the FDA.