FDA gives 510(k) approval for Acessa ProVu System in uterine fibroids.- Acessa Health.

Acessa Health announced 510(k) clearance from the FDA and U.S. commercial availability of the Acessa System�s most advanced and proprietary technology, the Acessa ProVu System. A fully-integrated radiofrequency ablation, ultrasound visualization, and guidance mapping system, Acessa ProVu enables physicians to effectively and safely treat women with symptomatic uterine fibroids.

Acessa ProVu System can treat nearly all sizes and locations of fibroids � including those outside the uterine cavity and within uterine walls. The Acessa procedure is a minimally invasive, outpatient treatment that involves two small incisions and uses radiofrequency ablation (i.e., heat) to destroy each targeted fibroid by applying controlled energy through a small needle array. The treated tissue may then be completely reabsorbed. There is no cutting or suturing of uterine tissue, patients experience minimal post-procedure discomfort and typically return to normal activities in 3-5 days.