FDA approves Acessa System (Halt Medical) for treating Uterine Fibroids

The FDA has cleared Acessa, from Halt Medical, a new medical system for treating Uterine Fibroids. To ablate targeted fibroids, the Acessa System delivers monopolar radiofrequency energy to tissue through a disposable electrosurgical RF handpiece. After treatment, the fibroid is re-absorbed by the surrounding tissue. Using this laparoscopic, outpatient procedure, the physician can provide a treatment that is low risk to the patient. By treating all of the fibroids, the risk of the symptom recurrence is low.

Two clinical studies have been published recently that demonstrate the effectiveness of the Acessa System for the treatment of Uterine Fibroids in 69 women aged 28 - 51. These two studies evaluated the pre-operative and post-operative reduction in symptom severity and improvement in quality of life for the patients who underwent treatment. Both studies demonstrated that symptom severity for symptomatic uterine fibroids was significantly reduced and the patients� quality of life significantly improved post treatment.