Acessa receives FDA approval for treating uterine fibroids


The US Food and Drug Administration (FDA) has cleared the Accesa system, a new medical technology used in the treatment of uterine fibroids, Halt Medical announced at the opening session of the Association of Gynecological Laparoscopists (AAGL) Global Congress on Minimally Invasive Gynecology.

“At last, a fibroid treatment that patients and physicians have been waiting for,” said David Levine, former board member of AAGL.

Acessa is used in a minimally invasive same-day surgery procedure where a slender handpiece is used to deliver radiofrequency energy to the fibroid.
 After treatment, the fibroid is re-absorbed by the surrounding tissue. In traditional fibroid surgery, layers of healthy tissue are cut through to gain access to the tumour or to remove the uterus entirely. This can lead to complications, significant pain, and long recovery times. Acessa treats just the fibroids, preserving the normal function of the uterus. Patients typically go home the same day with little pain and are back to regular activities in 5 days or less.

According to the Centers for Disease Control (CDC), fibroids are the leading cause for hysterectomy procedures worldwide. “It is estimated that 97% of women with fibroids choose to suffer with their symptoms rather than having their uterus removed. We are about to change all that,” said Jeffrey Cohen, CEO, Halt Medical. “Finally, gynecologists will have an alternative to hysterectomy for their fibroid patients.”

“The high patient satisfaction and low re-intervention rates seen in our clinical studies provides the opportunity for the healthcare system to replace radical surgery and save billions of dollars,” said Cohen.