AUSTIN, Texas–(BUSINESS WIRE)–Acessa Health Inc., developer of the Acessa® System, announced today that its laparoscopic radio frequency ablation technology was featured in a ten-year systematic review and meta-analysis of treatment options for uterine fibroids. The review, presented at MIS Week 2017 by Dr. Yelena Havryliuk of Weill Cornell Medical College, included an assessment of 143 journal articles from 2006 to 2016 and featured a quantitative synthesis (meta-analysis) of 45 studies during that period.
“The Acessa team is thrilled with the results of this comprehensive data review that overwhelmingly supports our technology as a superior intervention for women with symptomatic fibroids”
The weighted combined results from hysterectomy trials were compared with those from uterine-preserving fibroid studies including myomectomy, uterine artery embolization (UAE), laparoscopic radiofrequency ablation (Lap-RFA), and magnetic resonance-guided focused ultrasound (MRg-FUS). Key findings of the review include:
- Mean estimated blood loss following hysterectomy and myomectomy procedures exceeded 269 mL and 175 mL, respectively; Acessa’s Lap-RFA technology averaged 35 mL (nearly 8 times less than hysterectomy);
- Hospitalization after hysterectomy, myomectomy, and UAE averaged 2.0 – 2.4 days whereas Acessa’s Lap-RFA procedure was performed on an outpatient basis in all cases studied;
- Weighted average re-intervention rates after UAE and MRg-FUS ranged from 14.8% to 30.5% at 13-14 months whereas Acessa’s Lap-RFA averaged only 4.2% at 27-35 months;
- Readmission rates within 90 days of discharge for MRg-FUS, UAE, and myomectomy procedures were 7.4%, 3.4%, and 2.7%, respectively, whereas Acessa’s Lap-RFA was 0.7%; and
- Patients treated with Acessa’s Lap-RFA reported superior improvement in health-related quality of life and symptom severity scores relative to patients receiving hysterectomy, myomectomy or UAE.
“The Acessa team is thrilled with the results of this comprehensive data review that overwhelmingly supports our technology as a superior intervention for women with symptomatic fibroids,” said Kim Rodriguez, chief executive officer of Acessa Health Inc. “Acessa has been featured in more than 20 peer reviewed studies supporting its use. Dr. Harvryliuk’s meta review provides yet another encouraging data point as we seek to redefine the standard of care for millions of women suffering from fibroids.”
“I have used the Acessa System and been impressed with minimal blood loss, quick recovery, low re-intervention rates, and resolution of symptoms expressed by my patients,” said Dr. Havryliuk.
Uterine fibroids are typically benign tumors that can cause heavy menstrual bleeding, painful periods, uncomfortable pressure, and distention of the abdomen.1 Approximately 70 percent of women in the U.S. will develop fibroids by age 50; prevalence is higher among African Americans.2 Annual direct and indirect costs of symptomatic fibroids in the U.S. are estimated to exceed $34 billion.3
The Acessa System offers a safe, effective, and minimally invasive treatment. With Acessa, physicians use a laparoscopic instrument to deliver radiofrequency energy to fibroids. After the procedure, treated fibroids shrink and are reabsorbed by surrounding tissue.
Unlike many alternative interventions, Acessa can treat almost all sizes and locations of fibroids, including those outside the uterine cavity and within uterine walls. The procedure requires no cutting or suturing of uterine tissue, and patients typically go home the same day, experiencing minimal discomfort and a rapid return to normal activities. More than 1,700 women have been successfully treated with the Acessa System.
About the Acessa System
The Acessa System is the only radiofrequency ablation system cleared by the U.S. Food and Drug Administration and CE marked for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance. It has been the subject of 20 peer-reviewed publications across 750 study patients. In January 2017, the American Medical Association (AMA) issued a new Category 1 CPT code specifically for Laparoscopic Radiofrequency (RF) Ablation of Uterine Fibroids, paving the way for the Acessa procedure to become the standard of care for as many as 30 million women in the United States. For more information, visit acessaprocedure.com.
About Acessa Health, Inc.
Acessa Health is a women’s health innovator dedicated to advancing minimally invasive, uterine-sparing solutions for women with symptomatic fibroids. The company introduced the use of radiofrequency ablation for the treatment of uterine fibroids and is continuing to develop technologies that improve the lives of patients. Acessa Health is headquartered in Austin, TX.
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 Cardozo ER, Clark AD, Banks NK, Henne MB, Stegmann BJ, Segars JH. The estimated annual cost of uterine leiomyomata in the United States. Am J Obstet Gynecol. 2012;206:211.e1-211.e9