New System for the Treatment of Uterine Fibroids

The Acessa System presents a new alternative for patients suffering from uterine fibroids, allowing women to eliminate the symptoms of fibroids while keeping a healthy uterus, thus returning to a normal quality of life without the potential long-term complications due to hysterectomy. The system delivers monopolar RF energy to tissue through a disposable electrosurgical handpiece which is connected to a generator, with the tip inserted in the target tissue. The generator then provides sinusoidally varying voltage at 460 kHz to drive a current through the tissue to be ablated, causing controlled, local heating that results in targeted tissue destruction; the heat produced then disperses by conduction.

During these controlled ablations, the generator produces an alternating current, which flows between the Handpiece and the dispersive electrode pads, through the body of the patient. The electrically active portions at the tip of the handpiece consist of a stainless steel trocar and a deployable electrode array—not all of which need to be deployed during an ablation, depending on the size of the fibroid to be treated—with each electrode containing an internal thermocouple. The generator thus continuously samples the applied voltage, current, and temperatures from the thermocouples and other system parameters. The individual measurements are processed for internal control purposes.

The procedure is performed in an outpatient setting using a minimally invasive procedure, allowing minimal scarring and enabling the patient to return home the same day. The chances of the patient experiencing a recurrence of symptoms due to fibroid RF ablation are extremely low. The Acessa System and Procedure are a product of Halt Medical (Brentwood, CA, USA), and have been approved by the US Food and Drug Administration (FDA) for use in percutaneous, laparoscopic coagulation and ablation of soft tissue.

“Acessa is the first product cleared anywhere in the world that can be used by gynecologists to treat all fibroid symptoms and types,” said Jeffrey Cohen, CEO of Halt Medical. “It's estimated that 97% of women with fibroids choose to suffer with their symptoms rather than having their uterus removed. We're about to change all that.”

In traditional fibroid surgery, layers of healthy tissue are cut through to gain access to the tumor or to remove the uterus entirely. This can lead to complications, significant pain, and long recovery times.

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