AUSTIN, Texas--(BUSINESS WIRE)--Acessa Health Inc., developer of the Acessa Procedure™, announced today the successful launch and U.S. commercial availability of the Acessa ProVu System. Acessa ProVu received 510(k) clearance from the U.S. Food and Drug Administration (FDA) earlier this month and is the third-generation Acessa technology developed to treat uterine fibroid tumors with minimally-invasive laparoscopic radiofrequency ablation.
“For more than a decade, we have continually advanced the Acessa technology to help safely and effectively treat uterine fibroids with a less invasive approach. Acessa ProVu’s fully-integrated radiofrequency ablation, ultrasound visualization, and guidance mapping system represent another major step forward in providing women with an alternative to hysterectomy,” said Dr. Bruce Lee, Minimally Invasive Gynecologic Surgeon and Senior Medical Advisor for Acessa Health.
Dr. Nicole Williams, founder and Medical Director of the Gynecology Institute of Chicago, added, “After performing nearly 250 Acessa procedures, it was exciting to perform my first case with the new Acessa ProVu System. The combination of the proprietary intra-abdominal imagery and energy has made it easier for me to see and treat my patients’ fibroids, in turn, making the procedure more efficient.”
Acessa’s experience in nearly 3,000 procedures has advanced radiofrequency ablation under laparoscopic ultrasound guidance to produce a seamless user experience, utilizing the most innovative technological platform.
“Acessa ProVu has made fibroid treatment faster and easier compared to traditional laparoscopic uterine fibroid treatments,” noted Jessica Shepherd, MD, from Baylor University Medical Center in Dallas, TX. A recent 10-year systematic review1 (study link) comparing uterine-preserving alternatives to hysterectomy found that Acessa’s laparoscopic radiofrequency ablation procedure was associated with low complication rates, minimal blood loss, and low re-intervention rates. Additionally, patients reported major improvement in their quality of life and symptom severity scores compared to reports of more traditional interventions, such as hysterectomy, myomectomy, and UAE.
“I’ve used every generation of the Acessa family of products and can say, with certainty, that after using Acessa ProVu, the system has reached a pinnacle of technological innovation," said Carlos Quezada, MD, of Christus Health in San Antonio, TX. He added, “The Acessa ProVu system is going to allow more physicians to offer this treatment to their patients and I’m excited to be part of the movement changing how gynecologists approach the treatment of fibroids."
“The enthusiasm I hear from colleagues treating uterine fibroid patients is at an all-time high,” said Dr. Devin Garza, Director of Minimally Invasive Surgery at Renaissance Women's Group in Austin, TX. “Finally, we are seeing investment in clinical data, reimbursement, and technology advancement to offer women more minimally-invasive alternatives that give them the chance to retain their uterus and get back to normal activity quickly.”
“Our organization shares the widespread enthusiasm that Dr. Garza refers to when we look at our uterine fibroid business here at Acessa,” said Kim Rodriguez, president and CEO of Acessa Health Inc. “This excitement has led to dramatic demand for Acessa over the last several months. The initial feedback on Acessa ProVu is tremendously encouraging and we feel well-positioned to serve our physicians and their patients who suffer from symptomatic fibroids.”
About Acessa System
Unlike many alternative interventions, the Acessa ProVu System 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. The Acessa Procedure is the first and only solution with a category 1 CPT reimbursement code and widely established coverage.
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 its patients. Acessa Health’s headquarters are in Austin, Texas. For more information, visit AcessaProcedure.com.
1. Havryliuk Y, Setton R, Carlow JJ, Shaktman BD. Symptomatic Fibroid Management: Systematic Review of the Literature. JSLS. 2017;21(3).