Halt Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Acessa guidance hand piece for treatment of symptomatic uterine fibroids.
The FDA approved the Acessa system in April based on results of both the US and international trials evaluating the system for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance.
The Acessa procedure is a new minimally invasive, same-day (outpatient) therapy for fibroids of all types and sizes, in all locations within the uterine wall.
Using radio-frequency ablation technology, the Acessa system destroys each fibroid through a small needle array. The surrounding normal tissue is not affected and re-absorbs the destroyed fibroid after treatment.
According to Halt Medical, Acessa enables surgeons treat only the fibroids, while preserving normal function of the uterus.
Halt Medical claims that the minimally invasive laparoscopic procedure provides 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 in the development of safe, minimally invasive procedures for treatment of symptomatic uterine fibroids.
"The Acessa procedure provides women with an attractive uterine-sparing fibroid treatment alternative," Cohen said.
The Acessa system is now available at leading medical centers throughout the US. The system has also obtained approvals in EU, Canada and Mexico for treatment of symptomatic uterine fibroids.
Halt Medical's Acessa system features Acessa generator and Acessa handpiece. Through the disposable electrosurgical RF handpiece, the Acessa system delivers monopolar radio-frequency energy to ablate the targeted fibroids.
The handpiece is connected to the generator and the tip is inserted in the target tissue. The generator provides sinusoidally-varying voltage at 460kHz in order to drive a current through the tissue to be ablated.
The current delivered through the Handpiece causes controlled, local heating, resulting in targeted tissue destruction. The heat produced then disperses by conduction.
Image: A very large fibroid of the uterus, which is causing pelvic congestion on CT. Photo: courtesy of Jmh649.