Halt Medical, a medical device company, has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Acessa guidance hand piece, an accessory for the treatment of symptomatic uterine fibroids.
Approved by the FDA in April 2014, the Acessa guidance hand piece is a minimally invasive laparoscopic procedure that delivers radiofrequency energy to destroy the fibroids. The surrounding tissue re-absorbs the destroyed fibroid after the treatment.
According to Halt Medical, Acessa enables the surgeon to treat only the fibroids, while preserving normal function of the uterus.
Halt Medical claims that the minimally invasive laparoscopic procedure provides the treatment with no uterine incisions, no tissue removal or extraction, and no power morcellation.
Halt Medical CEO Jeffrey M Cohen said that the FDA’s clearance of this advanced technology is another step forward for the company in the development of safe, minimally invasive procedures for the treatment of symptomatic uterine fibroids.
"The Acessa Procedure provides women with an attractive uterine-sparing fibroid treatment alternative," Cohen added.
The Acessa system is now available at leading medical centers throughout the US.
Image: A very large fibroid of the uterus which is causing pelvic congestion on CT. Photo: Courtesy of Jmh649