Acessa Overview

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: ACESSA HEALTH - UTERUS MAPPED FOR FIBROIDS

Step 2: Handpiece Introduced into Fibroid

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

Handpiece Introduced

SOURCE: ACESSA HEALTH - 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: ACESSA HEALTH - 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: ACESSA HEALTH - 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 Acessa Health.

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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Clinical Studies

Acessa Health, Inc. believes in the importance of patient-centered outcomes research and the continued study of uterine-conserving procedures. To offer patients the best treatment alternatives, clinicians need to 1) be aware of all treatment alternatives, and 2) be provided with adequate safety, efficacy and cost data. To achieve this, Acessa Health is listing several post-market studies that compare available uterine-conserving procedures that are considered the standard of care within the gynecology community.

Providing gynecologists with these data in turn allows them to adequately inform their patients of the risks, benefits and costs of the various treatment alternatives for symptomatic uterine fibroids. We invite you to read a brief description on each of the post-market studies using the Acessa System. You may also refer to www.clinicaltrials.gov for further information on the Acessa Health studies.

Clinical Studies and Associated Publications

Clinical studies have been conducted and published regarding the safety, effectiveness and durability of the Acessa™ procedure for the treatment of uterine fibroids. The results from these trials consistently show that the Acessa outpatient procedure results in a reduction in uterine size, significantly reduced menstrual bleeding, significantly decreased symptom severity and a significantly improved quality of life. The following are descriptions of the clinical trial publications to date:

Trials of the Acessa System

Berman, et al described the 3-year follow up results of the study previously reported by Chudnoff et al (1-year results) and Guido et al (2-year results). In this report, 107 of the 135 treated subjects’ data were available at 3 years. Published in The Journal of Minimally Invasive Gynecology (JMIG) Berman JM, Guido RS, Leal JGG, Pemueller RR, Whaley FS, Chudnoff SG, Three Years’ Outcome from the Halt Trial: A Prospective Analysis of Radiofrequency Volumetric Thermal Ablation of Myomas 2014;21(5):767-774.

Findings:

  • Mean scores representing reduction in symptom severity, improvement in health-related quality of life and improvement in general health state were maintained.

Guido, et al, discussed long-term outcomes of the 124 women who were followed for two years in the previously reported by Chudnoff et al. Published in Health and Quality of Life Outcomes; “Radiofrequency Volumetric Thermal Ablation of Symptomatic Fibroids: Two Years’ Outcome from the Halt Trial.”

Findings:

  • The authors described the sustained decrease in symptom severity, the improvement in health-related quality of life and the low re-intervention rate at 2 years post-treatment.

Chudnoff, et al, wrote “Outpatient Procedure for the Treatment and Relief of Symptomatic Uterine Myomas,” which was published online by Obstetrics and Gynecology in November 2012 and in print in May 2013. The study was 12-month outcomes for the 135 women who were highly symptomatic and were treated with the Acessa System.

Findings:

  • Results showed meaningful reduction in menstrual blood loss along with a 25% reduction in uterine volume and 44% reduction in fibroid volume by 12 months post-treatment.
  • Significant patient quality-of-life improvements, significant decrease in symptom severity and menstrual blood loss, a low device-related adverse event rate and only one re-intervention lead the authors to conclude that treatment of fibroids with radiofrequency ablation (Acessa) may play a significant role in the future of fibroid management.

Brucker, et al, introduced the first randomized, prospective study of 50 patients who received laparoscopic fibroid treatment with either Acessa or myomectomy. This paper entitled,“Initial Results from a Randomized Controlled Study of Laparoscopic Radiofrequency Volumetric Thermal Ablation of Fibroids and Laparoscopic Myomectomy” is available in the International Journal of Gynecology and Obstetrics.

Findings:

  • In the immediate post-operative phase, mean hospitalization times were found to be nearly 3x longer in the laparoscopic myomectomy group. Intraoperative blood loss was also significantly greater in the myomectomy group.

Galen, et al, analyzed the data from the trial of 135 women, specifically the effect of intramural fibroids on menorrhagia. This article entitled “Does Menstrual Bleeding Decrease After Ablation of Intramural Myomas? A Retrospective Study” was published in the Journal of Minimally Invasive Gynecology.

Findings:

  • Acessa resulted in a clinically and statistically significant reduction in menstrual blood loss.

Levine et al describes the benefits of using laparoscopic ultrasound in “Sensitivity of Myoma Imaging Using Laparoscopic Ultrasound Compared With Magnetic Resonance Imaging and Transvaginal Ultrasound.”

Findings:

  • Acessa treatment was twice as effective in detecting myomas compared to transvaginal ultrasound and also superior to contrast-enhanced magnetic resonance imaging.

Galen, et al, published an article comparing the feasibility study results with the 1-year results from the international trial. This manuscript entitled “Laparoscopic Radiofrequency Ablation of Fibroids: Phase II / Phase III Results” has been accepted by the Journal of the Society of Laparoendoscopic Surgeons and will be available to subscribers in Vol. 18, Number 2 (Apr/May/Jun 2014 Issue).

Findings:

  • All studies (total 206 subjects) showed a post-treatment median of 4-5 days to return to work, significant reduction in uterine volume and significant improvements to symptoms, health and quality of life.

Macer published a November 2013 article in OBG Management entitled “For uterine-sparing fibroid treatment, consider laparoscopic ultrasound-guided radiofrequency ablation: Profile of a new minimally invasive treatment option.” Dr. Macer refers to the previously published results on RFA prior to Acessa and after Acessa was introduced as a new treatment option for symptomatic fibroids. He not only describes the technique in detail, but weaves in an interesting case study within the article. The full article is available in OBG Management November 2013 | Vol. 25, No. 11: 50-55.

The TRUST (Treatment Results of Uterine Sparing Technologies) Study

Study Purpose and Objectives

The purpose of this study is to evaluate the economic burden, safety and outcomes of three uterine-conserving treatment alternatives for symptomatic uterine fibroids: myomectomy, uterine artery embolization (UAE) and radiofrequency volumetric fibroid ablation using the Acessa™ System. In this study, subjects who have symptomatic uterine fibroids will be randomized to one of three uterine-conserving treatments based on the local standard of care.

Study Design

This is a post-market, randomized, prospective, multi-center, longitudinal, comparative study to evaluate the costs and health outcomes of the Acessa procedure vs. the standard uterine conserving technologies (myomectomy and UAE) for the treatment of symptomatic uterine fibroids in women who desire uterine conservation.

  • Group 1 will consist of women who desire uterine preservation and who are candidates for myomectomy. Group 1 women will be randomized 1:1 to Acessa or myomectomy (laparoscopic or abdominal).
  • Group 2 will consist of women who desire uterine preservation, but who are candidates for UAE. Group 2 women will be randomized 1:1 to Acessa or uterine artery embolization (UAE).

Sites may participate in Groups 1 and/or Group 2, depending on the availability of uterine conserving technologies and the local standard care pathway.

All eligible study subjects who are randomized to treatment will be expected to continue participation in the study for up to 60 months following treatment. Subject participation will include evaluations pre-procedure (baseline), immediate post-procedure and office or phone follow-up visits at 1 week and 4-8 weeks post-treatment. Telephone follow-up will occur at 24 to 72 hours post-treatment. Questionnaires will be distributed at baseline, 3, 6, 12, 24, 36, 48, and 60 months post-procedure. Complications and reinterventions data will be collected for up to 60 months post-treatment. Cost data pertaining to the treatment of the fibroids will be collected at the following time points: hospitalization (including the surgical procedure), post-procedure recovery, and post discharge up to 60 months.

Inclusion Criteria

Women who:

  • Are ≥ 18 years old and menstruating
  • Have symptomatic uterine fibroids
  • Have a uterine size ≤16 gestational weeks as determined by pelvic exam
  • Have all fibroids that are less than 10 cm in any diameter
  • Desire uterine conservation
  • Have had a normal Pap smear within the past 36 months defined as “no untreated cervical malignancy or dysplasia”
  • Are willing and able to comply with all study tests, procedures and assessment tools
  • Are capable of providing informed consent

Exclusion Criteria

Women who:

  • Have contraindications for laparoscopic surgery and/or general anesthesia
  • Are expected to be high risk for, or are known to have, significant intra-abdominal adhesions (defined as adhesions that would require extensive dissection to mobilize and view all surfaces of the uterus)
  • Patients requiring major elective concomitant procedures (e.g., hernia repair)
  • Are pregnant or lactating
  • Have taken any depot GnRh agonist within three months prior to the screening procedures
  • Have an implanted intrauterine or fallopian tube device for contraception that cannot or will not be removed at least 10 days prior to treatment
  • Have chronic pelvic pain known to not be due to uterine fibroids
  • Have known or suspected endometriosis or adenomyosis
  • Have active or history of pelvic inflammatory disease
  • Have a history of, or evidence of, gynecologic malignancy or pre-malignancy within the past five years
  • Have had pelvic radiation
  • Have a non-uterine pelvic mass over 3 cm
  • Have a cervical myoma
  • Have one or more completely intracavitary submucous fibroids (Type 0) or only Type 0/1 submucous fibroids that are better treated via hysteroscopic methods
  • Should not participate in the study in the medical opinion of the investigator
  • Are not willing to be randomized to treatment

If you are interested in learning more about this study, please refer to the clinicaltrials.gov website: http://www.clinicaltrials.gov/ct2/show/NCT02163525?term=Halt+medical&rank=5 (USA) or http://www.clinicaltrials.gov/ct2/show/NCT01563783?term+TRUST&rank=3 (Canada)

ClinicalTrials.gov Identifiers:
NCT02163525 and NCT01563783

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The LUSTOR (Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions) Study

Study Purpose and Objectives

The purpose of this study is to compare the outcomes of two uterine-conserving treatment alternatives for symptomatic uterine fibroids: laparoscopic myomectomy (LM) and global fibroid ablation (GFA) using the Acessa System. Laparoscopic ultrasound (LUS) is a standard step prior to the Acessa procedure but has not been a standard step prior to LM. Incorporating LUS as a first step prior to both treatments allows the surgeon to have equal access to valuable imaging information and to plan treatment accordingly. By randomizing the subject immediately after laparoscopic ultrasound, selection bias toward one treatment or the other following the LUS is eliminated.

The primary objective of this study is to compare the mean time to discharge from the hospital following laparoscopic treatment of fibroids by either myomectomy or by Acessa. Secondary objectives are to compare multiple safety and efficacy outcome measures, mainly complications, readmissions and reintervention rates, post-op use of pain medication, recovery rates including return to work, post-treatment changes in the severity of fibroid related symptoms including menstrual changes, post-treatment changes in health-related quality of life and general health status and overall patient satisfaction with the treatment.

Study Design

This is a post-market, randomized, prospective, single center, longitudinal, comparative study to evaluate the outcomes of GFA vs the current standard of care at a single center (laparoscopic myomectomy) for the treatment of symptomatic uterine fibroids in women who desire uterine conservation.

Fifty subjects recruited from referral centers within Germany have been treated. All subjects recruited consisted of women who desired uterine preservation and who were willing to be randomized. All study subjects will be expected to continue participation in the study for 60 months following treatment. The multiple endpoints of the clinical investigation will be assessed and reported at various intervals.

This study is currently closed to enrollment and all subjects are in follow-up.

Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Study and Registry

If you are interested in learning more about this study or the registry, please refer to fibroids.ucsf.edu or the clinicaltrials.gov website: http://www.clinicaltrials.gov/ct2/show/NCT01840124?term=acessa&rank=2 (Study) or
http://www.clinicaltrials.gov/ct2/show/NCT02100904?term=NCT02100904&rank=1 (Registry)

University of California, Davis
Davis, California, United States
Contact: Sarah Steimer sarah.stemier@ucdmc.ucdavis.edu

University of California, Irvine
Irvine, California, United States
Contact: Naghmeh S. Saberi, MD 714-456-5694
Contact: Mark Vuchinich, MD 714-456-5694

University of California, San Diego
La Jolla, California, United States
Contact: Vanessa Candare 858-657-1299

University of California, Los Angeles
Los Angeles, California, United States
Contact: Ram K.Paarvatane 310-825-5255 uclaobgynresearch@mednet.com
Contact: Nicole Pennington 310-794-9652

University of California, San Francisco
San Francisco, California, United States
Contact: Stephanie Lemp 415-297-3114 lemps@obgyn.ucsf.edu
Contact: Lisa Abinanti 415-353-9978 lisa.abinanti@ucsf.edu

You may also refer to the clinicaltrials.gov website:
ClinicalTrials.gov Identifiers: NCT01840124 and NCT02100904

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Scientific Publications

Interim Analysis of a Randomized Controlled Trial Comparing Laparoscopic Radiofrequency Volumetric Thermal Ablation of Uterine Fibroids With Laparoscopic Myomectomy

Bernhard Krämer, Markus Hahn, Dorit Kraemer, Keith B. Isaacson, Sara Y. Brucker.
The article was published in the International Journal of Gynaecology and Obstetrics, 2016; 133(2): 206-11 and is available online at http://www.ncbi.nlm.nih.gov/pubmed/26892690

Three Years’ Outcome from the Halt Trial: A Prospective Analysis of Radiofrequency Volumetric Thermal Ablation of Myomas

Jay M. Berman, MD, Richard S. Guido, MD, José Gerardo Garza Leal, MD, Rodolfo Robles Pemueller, MD, Fredrick S. Whaley, PhD, Scott G. Chudnoff, MD, MS
The Journal of Minimally Invasive Gynecology, 2014; http://www.jmig.org/article/S1553-4650(14)00194-0/fulltext

Initial Results from a Randomized Controlled Study of Laparoscopic Radiofrequency Volumetric Thermal Ablation of Fibroids and Laparoscopic Myomectomy

Sara Y. Brucker, Markus Hahn, Dorit Kraemer, Florin Andrei Taran, Keith B. Isaacson, Bernhard Krämer.
The article was published in the International Journal of Gynaecology and Obstetrics and is available online at http://authors.elsevier.com/sd/article/S0020729214001040

Radiofrequency volumetric thermal ablation of symptomatic fibroids: two years’ outcome from the Halt Trial

Richard S. Guido, James Macer, Karen Abbott, Janice L. Falls, Ian B. Tilley, Scott G. Chudnoff
The manuscript was published in Health and Quality of Life Outcomes, 2013; 11:139 and is available online at http://www.hqlo.com/content/11/1/139

Outpatient Procedure for the Treatment and Relief of Symptomatic Uterine Myomas

SG Chudnoff, MD, MS, JM Berman, MD, DJ Levine, MD, M. Harris, MD, RS Guido, MD, E. Banks, MD
This article was published in Obstetrics and Gynecology, 2013; 121(5):1075–82. An abstract is available at www.ncbi.nlm.nih.gov/pubmed/23635746

Sensitivity of Myoma Imaging with Laparoscopic Ultrasound Compared to Magnetic Resonance Imaging and Transvaginal Ultrasound

DJ Levine, MD, JM Berman, MD, M. Harris, MD, SG Chudnoff, MD, MS, FS Whaley, PhD, SL Palmer, MD
This article was published in Journal of Minimally Invasive Gynecology, 2013; 20(6):770-774. An abstract of the article is available at http://www.jmig.org/article/S1553-4650(13)00205-7/abstract

Does menstrual bleeding decrease after ablation of intramural fibroids? A Retrospective Study

DI Galen, MD, KB Isaacson, MD, BB Lee, MD
This article was published in Journal of Minimally Invasive Gynecology, 2013; 20(6):830-835. An abstract of the article is available at http://www.jmig.org/article/S1553-4650(13)00282-3/abstract

Laparoscopic radiofrequency fibroid ablation: Phase II / Phase III Results

Donald I. Galen, Rodolfo Robles Pemueller, José Gerardo Garza Leal, Karen Abbott, Janice Falls, James Macer
This paper has been published in JSLS, 2014; 18(2) and is available for viewing online at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4035627/

Laparoscopic Ultrasound-Guided Radiofrequency Ablation: A Viable Option for Your Patients with Fibroids

James Macer
The full article is available in OBG Management, 2013; 25(11):50-55 and is available for viewing online at
http://www.obgmanagement.com/the-latest/past-issues-single-view/for-uterine-sparing-fibroid-treatment-consider-laparoscopic-ultrasound-guided-radiofrequency-ablation/7558329afb80a989b3b3181162253132.html

Laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation of symptomatic leiomyomas: feasibility study using the Halt 2000 Ablation System

JG Garza Leal, M.D., I Hernandez Leon, M.D., L Castillo Saenz, M.D., BB Lee, M.D.
Published in Journal of Minimally Invasive Gynecology, 2011; 18(3):364–71. An abstract of the article can be found at http://www.jmig.org/article/S1553-4650(11)00112-9/abstract

Laparoscopic radiofrequency volumetric thermal ablation of uterine myomas with 12 months of follow-up

R Robles, V Aguirre, AI Argueta, MR Guerrero
This article was published in the International Journal of Gynaecology and Obstetrics, 2013; 120:65–9. The open access article is available at http://www.ijgo.org/article/S0020-7292(12)00503-6/fulltext

The electrical conductivity of in vivo human uterine fibroids.

R DeLonzor, R Spero, J Williams
This article was published in the International Journal of Hyperthermia, 2011; 27(3):255-65. The abstract can be accessed online at http://www.ncbi.nlm.nih.gov/pubmed/?term=International+Journal+of+Hyperthermia%2C+Delonzor+R

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Professional Events

Acessa Health will be presenting the Acessa System for fibroid treatment at the following medical conferences and meetings. If you are interested and have the time to visit with us, please take the opportunity to stop by our booth.

May 2-6, 2015
The American College of Obstetricians and Gynecologists
63nd Annual Clinical Meeting
Booth 1529
Moscone Center
San Francisco, CA

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Practice Benefits

The Acessa Procedure - The Optimal Solution for Treatment of Uterine Fibroids

Both patients and physicians want a solution that is minimally invasive, allows for rapid recovery, has a low rate of recurrence and eliminates the need for a hysterectomy.

With the Acessa System, both the surgeon and the patient are able to achieve their goals. Using a laparoscopic, outpatient procedure, the physician can provide a treatment that is low risk to the patient and is highly successful at treating all of the patient’s existing fibroids. By treating all of the fibroids, the risk of the symptom recurrence is low. Patients generally take mild anti-inflammatories following the procedure, which allows them to return to work in 4-5 days.

Patients Want to End Their Suffering

Women with symptomatic uterine fibroids have to endure the bleeding, pelvic pain and frequent urination that are brought on by their condition. They worry that if their condition continues, their quality of life will continue to deteriorate, and they may have to have major surgery.

Physicians Are Frustrated With Their Current Choices

Physicians see their patients suffering with these symptoms, and they are frustrated because their current treatment options are limited. Depending on the course of therapy the patient chooses, the physician knows the patient will either have a high rate of recurrence or may have to endure a hysterectomy.

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Reimbursement

Acessa Health, Inc. is dedicated to offering reimbursement support and resources for healthcare professionals seeking a better understanding of coding, coverage and payment for the Acessa™ procedure. Acessa is a treatment for symptomatic uterine fibroids.

Acessa Health has engaged an experienced Reimbursement team to work directly with customers. The Acessa Patient Support Group will assist providers in their efforts to secure benefit coverage and appropriate payment. In addition, the Patient Support Group is experienced with the many challenges that arise when dealing with prior authorizations, claim denials, and any reimbursement obstacles.

Download a Case Management informational sheet that describes the services The Acessa Patient Support Group offers to Acessa customers.

For billing codes, refer to the 2017 Acessa Physician Coding Sheet.

For assistance, contact your local sales representative, call (866) 209-9185, or email help@Acessasupport.com.

Information provided on this site was gathered from third party sources and is subject to change without notice by Acessa Health.

This information is provided for your convenience and should be verified. Acessa Health does not warrant or guarantee that the use of information provided will result in coverage or payment.

Providers are solely responsible for determining medical necessity and for being in compliance with regulatory, Medicare and any payer rules, regulations and agreements as well as for the information submitted with claims and appeals.

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