Uterine fibroids are a large part of most Gynecologists’ practice. The severity of the patients’ symptoms can vary widely, and this variability results in challenges in treating each patient effectively. The current treatment choices either leave the patient at significant risk of recurrence or subject the patient to invasive surgery and long recovery times. Patients and their Gynecologists are seeking an alternative to treat fibroids safely, effectively, minimally invasively, and which enables women to quickly return to their normal lives.

Acessa – A Better Option

The Acessa Procedure presents a new standard of care for patients suffering from uterine fibroids. With the Acessa procedure, a woman’s symptoms are significantly reduced or eliminated while preserving a healthy uterus. This minimally invasive, laparoscopic outpatient procedure enables the patient to quickly return to a normal quality of life without the potential long-term complications or long recovery time associated with hysterectomy. Patients return home the same day and typically resume work and other normal daily activities in 3-5 days. Importantly, the procedure has an excellent safety profile with a less than 4% complication rate and a very low incidence of recurring symptoms or the need for additional intervention.

The Acessa™ Procedure for Symptomatic Uterine Fibroids

The Acessa procedure is a minimally invasive, outpatient treatment for fibroids of all types and sizes and in all locations within the uterine wall. It uses radiofrequency ablation to destroy each fibroid by applying controlled energy through a small needle array. The surrounding normal tissue is not affected. The destroyed tissue may then be completely reabsorbed.

Step 1: Uterus Mapped for FibroidsThe laparoscopic ultrasound probe is used to determine the location and size of all fibroids present. Intra-abdominal ultrasound allows excellent visualization of fibroids as small as 2 mm in diameter.

Uterus Mapped

SOURCE: HALT MEDICAL – UTERUS MAPPED FOR FIBROIDS

Step 2: Handpiece Introduced into Fibroid

The Handpiece tip is advanced into the fibroid with ultrasound guidance.

Handpiece Introduced

SOURCE: HALT MEDICAL – HANDPIECE INTRODUCED INTO FIBROID

Step 3: Deployment of Handpiece Electrodes

The electrode array is deployed. Laparoscopic and ultrasound evaluation confirm that the electrodes remain within the fibroid.

Deployment

SOURCE: HALT MEDICAL – DEPLOYMENT OF HANDPIECE ELECTRODES

Step 4: Ablation and Withdrawal

The appropriate duration of ablation is determined, the treatment is applied, and any bleeding is controlled as the Handpiece is withdrawn.

Ablation

SOURCE: HALT MEDICAL – ABLATION AND WITHDRAWAL
References

Speroff, M Fitz. Clinical Gynecologic Endocrinology and Infertility. 7th ed. Lippincott Williams & Wilkins; 2004.
Casini ML, Rossi F, Agostini R, Unfer V. Effects of the position of fibroids on fertility. Gynecol Endocrinol. 2006 Feb;22(2):106-9.

Acessa Procedure Video

The Acessa Procedure is minimally invasive and done on an outpatient basis. Using standard laparoscopic skills, the gynecological surgeon places two ports, one 5 mm and one 10 mm, along with a percutaneous insertion of the Acessa Handpiece to execute the procedure. The procedure takes approximately 1 to 2 hours when done by an experienced surgeon. To learn more, please watch the brief video below, which demonstrates the Acessa Procedure. Interested surgeons can contact Halt Medical or download the patient brochure.

Destroys All of the Fibroids

Using an intraoperative ultrasound, the surgeon is able to clearly identify all of the patient’s fibroids and destroy them, no matter what the location. The Handpiece is advanced to each of the targeted fibroids and inserted 1 cm into the fibroid. The electrode array is then deployed and the surgeon is able to destroy the fibroid.

Handpiece Allows Control of All Generator Functions

Once the Handpiece is inserted into the fibroid, the surgeon can use controls on the Handpiece to enter information about the procedure and control the parameters of the treatment. Pressing a foot pedal switch starts the procedure. When the ablation is completed, the surgeon uses the Handpiece controls to switch to coagulation mode and withdraw the Handpiece from the fibroid.

Patient Returns Home Same Day

The Acessa procedure is done on an outpatient basis. Women typically return to work within only a few days. With Acessa, the surgeon is able to find and destroy all of the patient’s fibroids thus reducing the risk of recurrence of symptoms, while preserving the patient’s uterus.

To see a video and learn more about the Acessa Procedure, please click on the video below:

Acessa System Overview

Acessa represents advanced technology for the minimally invasive treatment of uterine fibroids. The system incorporates the Acessa Generator and the Acessa Handpiece, and utilizes the most advanced level of radiofrequency (RF) thermal ablation in the management of uterine fibroids. These components, coupled with the visualization capabilities of laparoscopic ultrasound, enable the surgeon to accurately identify the patient’s uterine fibroids and treat all of her fibroids, while preserving a healthy uterus.

To ablate targeted fibroids, the Acessa System delivers monopolar radiofrequency energy to tissue through a disposable electrosurgical RF Handpiece. The Handpiece is connected to the Generator and the tip is inserted in the target tissue. The Generator provides sinusoidally-varying voltage at 460 kHz 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. 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 the deployable Electrode Array. The electrodes may or may not be deployed during an ablation, depending on the size of the fibroid to be treated. Each electrode contains an internal thermocouple. The Generator continuously samples the applied voltage, current and temperatures from the thermocouples that are embedded in the electrodes and other system parameters. The individual measurements are processed for internal control purposes.

Thermal Ablation in the Treatment of Fibroids

Energy-based platforms have been studied and used to treat uterine fibroids for more than 20 years. These efforts have led to the development of a wide range of devices that are more minimally invasive and have the ability to improve patient symptoms equivalent to or better than other traditional treatment methods such as myomectomy or hysterectomy.

Thermal ablation devices treat the fibroid by heating the tissue. This heating is accomplished by converting some form of energy, usually electrical or light energy, into intracellular mechanical energy that creates heat within the cells of the target tissue. This heating process causes necrosis in the target tissue, which causes the fibroid to shrink and usually stops the fibroid from causing symptoms for the patient.

The idea of ablating fibroids with energy was originally referred to as myoma coagulation or myolysis. It was initially performed using a laser to deliver energy to the fibroid during laparoscopy or hysteroscopy. The procedure evolved when the bipolar radiofrequency needle electrode was developed. The bipolar electrode was initially used in 1993 by Gallinat and Lueken. However, while the laser and bipolar methodologies demonstrated good efficacy, they did not find widespread acceptance.[1] There were concerns within the surgeon community regarding postoperative complications due to adhesions, the time it took to complete the procedure and the ability to clearly identify the targeted tissue.

One of the limitations of the original technology used for thermal ablation of fibroids was that the surgeon was not able to determine the extent of the ablation during the procedure. Researchers realized that creating multiple ablation sites within a fibroid would maximize the volume of tissue ablated. However, attempting to perform multiple insertions of a needle electrode would be time consuming and would create adhesions in the patient, as well as potentially introduce other complications.

Recent developments of RF platforms, such as the Acessa System, have helped address these concerns. The Acessa Handpiece incorporates an electrode array, which creates a controlled zone of ablation. The size of the ablation is dependent on the size of the fibroid. Additionally, the procedure incorporates the use of both a laparoscope and laparoscopic ultrasound for visualization and guidance during the procedure. Both enhance the surgeon’s ability to effectively identify and treat most fibroids during a single procedure.

[1] S. Jones et al, Radiofrequency Ablation for Treatment of Symptomatic Uterine Fibroids, Obstetrics and Gynecology International, Volume 2012.

How Does Radiofrequency Volumetric Thermal Ablation Work?

Radiofrequency Volumetric Thermal Ablation (RFVTA) utilizes electrical energy that has been safely used in many medical applications. At its simplest level, this electrical energy is used to create heat in the surrounding tissue and destroy diseased cells. The heat is generated in a specific location, at a specific temperature, for a specific period of time. When applied correctly, RFVTA results in the death of the diseased tissue.

The Acessa procedure is done on an outpatient basis. Once the patient is sedated, the fibroids are visualized using ultrasound, and the Handpiece, including the Electrode Array, is inserted through the skin and placed into the target tissue. The surgeon then deploys the Electrode Array from the end of the Handpiece. A specially designed energy generator that is connected to the Handpiece is then activated and delivers radiofrequency (RF) energy to the Handpiece.

The RF energy flows through the electrodes and creates heat in the tissue through ionic agitation and frictional heat. Once the target temperature has been reached, the heat kills the target tissue within only a few minutes. The heat is continuously monitored through the thermocouples in the electrodes and the generator automatically adjusts the power so that the temperature in the target tissue remains constant. The heat treats the tumor and leads to cell death. The dead cells are gradually replaced by fibrosis and scar tissue. The body will naturally reduce the size of the scar tissue and eliminate it.

Laparoscopic Ultrasound in Fibroid Treatment

Laparoscopic Ultrasound in Fibroid Treatment

Laparoscopic ultrasound is used with the Acessa System to identify the uterine fibroids during the surgical procedure. The use of this imaging technique enhances the ability of the surgeon to identify and treat all of the fibroids present and helps to improve the efficacy of the procedure.

How Does Laparoscopic Ultrasound Work?

Ultrasound transducers are designed to produce ultrasound waves of different frequencies. Higher frequencies will produce images that have higher resolution. As a result, a 10 MHz signal will produce a much clearer image than a 5 MHz signal. The issue for the surgeon is that higher frequencies weaken more rapidly than the lower frequencies. Therefore, a 10 MHz transducer can only penetrate about 5 cm into a solid organ and does not deliver clear images of fibroids within the uterus, if done trans-abdominally.

On the other hand, intraoperative use of the ultrasound probe enables use of the higher frequency transducer because it can be placed directly on the surface of the uterus. As a result, intraoperative ultrasound images are much clearer and provide significantly more accurate results than other imaging methods.

Ultrasound images can be complicated by refraction and mirror images from other solid surfaces. However, by scanning the uterus through multiple planes, the surgeon can confirm the presence and location of fibroids. The entire uterus is mapped slowly and carefully, laterally from right and left and from both the anterior and posterior perspectives.

What are the Benefits?

Laparoscopic ultrasound is better than other methods of visualizing uterine fibroids. In a recent clinical study, laparoscopic ultrasound identified 107% more fibroids than trans-vaginal ultrasound and 46% more fibroids than magnetic resonance imaging (MRI). As a result, it provides significant benefits to gynaecologic surgeons in the treatment of symptomatic uterine fibroids.

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