Coverage decisions are made by insurance carriers after a thorough review of the published literature. To date, there are over 20 peer-reviewed publications that detail the safety, efficacy and durability of the Acessa Procedure and include both short and long-term patient outcomes.
Uterine fibroids are benign, muscular tumors in a woman's uterus that can cause heavy bleeding, painful periods, pressure, and distention of the abdomen . At least 70% of women in the U.S. will develop fibroids by the age of 50, with the prevalence even higher among African American women . As a result, they remain a major women's health issue with significant economic and reproductive impact. The NIH has determined that direct health care costs for the surgical treatment of fibroids is more than $2.1 billion annually . In a Nationwide Inpatient Sample, over half a million women underwent hysterectomy for benign gynecologic conditions  and the American Congress of Obstetricians and Gynecologists (ACOG) state that 39% of all hysterectomies are due to fibroids . Over time, patients and gynecologists are turning to less invasive procedures and laparoscopic options are becoming more popular .
The Acessa Procedure is a minimally invasive, uterine-conserving, laparoscopic procedure that delivers radiofrequency energy to destroy the fibroids. After treatment, the fibroid is reabsorbed by the surrounding tissue. The procedure allows the surgeon to treat only the fibroids, while preserving normal function of the uterus. Patients typically go home the same day with minimal discomfort, and enjoy a rapid return to normal activities.
The company is focused on establishing a new standard of care for women with symptomatic uterine fibroids. The Acessa System is cleared by the FDA and has CE mark for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance. The Company is located in Brentwood, CA. For information about the Acessa System, please visit www.acessaprocedure.com.
2. Baird DD et al. High cumulative incidence of uterine leiomyoma in black and white women: Ultrasound evidence. Am J Obstet Gynecol 2003; 188 (1):100-107.
3. National Institutes of Health fact sheet: http://report.nih.gov/nihfactsheets/viewfactsheet.aspx?csid=50
4. Jacoby VL, Autry A, Jacobson G, Domush R, Nakagawa S, Jacoby A. Nationwide Use of Laparoscopic
Hysterectomy Compared With Abdominal and Vaginal Approaches Obstet Gynecol 2009;114( 5):1041-1048.
5. www.ACOG.org. 2011 Women's Health Stats and Facts: p.18.
6. Twijnstra AR, Kolkman W, Trimbos-Kemper GC, Jansen FW. Implementation of advanced laparoscopic surgery in gynecology: national overview of trends. J Minim Invasive Gynecol 2010;17(4):487-492.
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SOURCE Halt Medical, Inc.