Acessa Health Cleared for Uterine Fibroid Ablation Device

The FDA granted 510(k) clearance to Acessa Health’s ProVu System, a device used to treat women with symptomatic uterine fibroids who don’t want to undergo a hysterectomy.

The system combines radiofrequency ablation, guidance mapping and ultrasound visualization to target and ablate the fibroid. The ablated fibroid is then absorbed harmlessly by the body over time.

The minimally-invasive Acessa Procedure has been clinically proven through long-term data to be a safe alternative to hysterectomy.