AUSTIN, Texas--(BUSINESS WIRE)--Acessa Health Inc., developer of the Acessa ProVu® System, announced today that clinical results after the Acessa Procedure will be the focus of two presentations at the 2019 American Association of Gynecologic Laparoscopists (AAGL) Global Congress on Minimally Invasive Gynecology Nov. 11-13, 2019 in Vancouver.
The Acessa Procedure is specifically designed to treat women suffering from uterine fibroids and is clinically proven with long-term data as a safe alternative to hysterectomy and myomectomy. Over 3,000 procedures have been performed to-date. Acessa ProVu® is the third generation of Acessa’s minimally invasive, laparoscopic radiofrequency ablation solution – and is the first and only solution with a category 1 CPT reimbursement code and widely established coverage. It has been the subject of 47 peer-reviewed publications across 850 study patients.
“Twenty nineteen has been a pivotal year for Acessa Health with the availability of the Acessa ProVu® System and the growing demand from physicians and women who see the benefits of this treatment option for fibroids,” said Kim Rodriguez, President and CEO, Acessa Health. “The presentations at AAGL showcase the growing amount of real-world clinical evidence as well as the proven safety of the procedure.”
The presentations include:
- “Post-Market Surgeon Safety Outcomes and Experience Performing Laparoscopic Ultrasound-Guided Radiofrequency Ablation using the Acessa System” presented by Bala Bhagavath, M.D. – Department of Obstetrics and Gynecology, University of Rochester, Rochester, New York. The study analyzed results of real-world, post IDE, safety and learning curve with 100 patients across 26 surgeons.
- “An Observational Study of Reproductive Outcomes in Clinical Trials and Commercial Settings After Laparoscopic Radiofrequency Ablation of Symptomatic Myomas” presented by Jay M. Berman, M.D. – Professor and Vice Chair, Department of Obstetrics and Gynecology, Wayne State University School of Medicine, Detroit, Michigan. The study analyzed safety of pregnancy outcomes after laparoscopic radiofrequency ablation of uterine myomas.
In addition, Soyini Hawkins, M.D., and a panelist of Acessa users presented a case study using pre-recorded surgical video footage at a professional education event on Sunday. The well-attended event highlights the company’s intense focus on educating physicians who care for women suffering from uterine fibroids.
About the Acessa Procedure
Unlike many alternative interventions, the Acessa Procedure can treat nearly all sizes and locations of fibroids – including those outside the uterine cavity and within the uterine walls. The Acessa Procedure is a minimally invasive, outpatient treatment that involves two small incisions and uses radiofrequency ablation (i.e., heat) to destroy each targeted fibroid by applying controlled energy through a small needle array. The treated tissue may then be completely reabsorbed. There is no cutting or suturing of uterine tissue. Patients experience minimal post-procedure discomfort and typically return to normal activities in 3-5 days.
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, under laparoscopic ultrasound guidance, and is continuing to develop technologies that give women more options. Acessa Health’s headquarters are in Austin, Texas. For more information, visit AcessaProcedure.com.
Insufficient data exist on which to evaluate the safety and effectiveness of Acessa procedure in women who plan future pregnancy. Therefore, the Acessa procedure is not recommended for women who are planning future pregnancy.