FDA Panel Backs Endometrial Ablation Device.

Final approval depends on lowering of cryotherapy unit's high malfunction rate.

GAITHERSBURG, MD. -- A Food and Drug Administration expert panel has recommended that an endometrial ablation device that uses cryotherapy to destroy tissue be approved if certain conditions are met.

In a 9-0 vote, the FDA's Obstetrics and Gynecology Devices Advisory Committee agreed that the device was approvable specifically to reduce "abnormal uterine bleeding due to benign causes in premenopausal women for whom childbearing is complete." Nevertheless, panelists expressed concern about the device's 26.5% malfunction rate and stated that the company would have to correct the mechanical problems and provide prospective data documenting a lower malfunction rate before it could be marketed.

The FDA usually follows the advice of its panels, which are made up of outside experts.

The First Option Uterine Cryoablation Therapy system is designed for in-office use. It consists of a console; a cryoprobe; and a disposable control unit, which is a sterile unit that covers the probe and has freeze and heat buttons, an injection port for saline, and several other features. The system is used in conjunction with ultrasound, according to the device's manufacturer, San Diego-based CryoGen.

During the procedure the cryoprobe, an insulated shaft with a metal tip that is 43 cm long and cools to -80[degrees]C, performs a 4-minute freeze of one cornua, followed by a 6-minute freeze in the opposite cornua. The procedure is done under ultrasound guidance to ensure that the cryoprobe is in the uterine cavity, said Veronica Price, a biomedical engineer at the FDA and lead reviewer of the application.

A multicenter clinical trial compared 12-month success rates in 189 women treated with cryoablation and 89 treated with rollerball endometrial ablation (REA), which has an expected success rate of 85%. All patients were preoperatively treated with Lupron to thin the endometrial lining; women with myomectomy, prior ablation therapy, uterine reconstructive surgery, or a positive endometrial biopsy were excluded from the study.