New Data Show that Women with Uterine Fibroids Experienced Significant and Long-Term Improvement in Their Symptoms with the Acessa™ Procedure Minimally Invasive, Out-Patient Procedure Enables Rapid Recovery
LIVERMORE, Calif., Nov. 12, 2013 /PRNewswire/ -- Halt Medical today announced that data from a large multi-center clinical study of the Acessa™ Procedure showed that women with uterine fibroids experienced significant and long-term improvement in their symptoms and for 95 percent of women, use of this procedure did not require further fibroid treatment during the two-year study follow-up. Results from The Halt Fibroid Study were presented today at the 42nd AAGL Global Congress on Minimally Invasive Gynecology near Washington, D.C. The AAGL is the world's premiere professional society dedicated to minimally invasive surgery in gynecology.
According to the National Institutes of Health, uterine fibroids are a common condition affecting at least 70 percent of all women by age 50. The size of fibroids can vary greatly, ranging from microscopic to the size of a melon. And symptoms may vary widely from prolonged and heavy menstrual blood flow and bloating to pelvic pain, cramping, and anemia. While fibroids are nearly always noncancerous, they are most often treated by the complete removal of the uterus in a hysterectomy procedure.
The population under study included 135 women with ≤ 6 treatable fibroids and heavy menstrual bleeding who were treated with the Acessa Procedure and followed for 24 months. Patients participating in the study quickly experienced significant improvement in their symptom severity; these results were sustained over two years with the symptom severity scores decreasing significantly compared to the pretreatment scores. The overall incidence of adverse events and retreatment rates were low.
Women with fibroids often are self-conscious, concerned about their health and lack the energy to participate in physical or social activities. The Halt Fibroid Study also found that many women treated with Acessa experienced substantial improvements in how they felt about their condition and themselves as early as three months following the procedure, with results maintained for two years. Importantly, health-related quality of life (HRQL) scores increased significantly by 41 percent when compared to the baseline measurement. Additionally, HRQL sub-scores also improved significantly from baseline to 24 months in all categories (concern, activities, energy/mood, control, self-consciousness, and sexual function).
"The goal in developing the Acessa Procedure was to provide women with an option for effectively managing their fibroid symptoms while leaving their uterus intact, which isn't possible with some other procedures. We also wanted to minimize the impact that treatment would have on their lives," said Jeffrey M. Cohen, Halt Medical CEO. "The data presented at AAGL show that the same-day Acessa Procedure provides meaningful and lasting symptom control while leaving the uterus intact, minimizing the mental, physical and emotional impact of uterine fibroids on patients' daily lives."
In addition to managing fibroid symptoms and improving health related quality of life, treatment with Acessa also enables patients to rapidly return to normal life activities. In another study presented at AAGL, patients with uterine fibroids were randomized to receive treatment with standard surgery or the Acessa procedure. Data showed that those patients treated with standard surgery stayed three times longer in the hospital and were slower to return to regular activities than those patients who were treated with the Acessa Procedure.
The Halt Study Design
The Halt Trial was designed to determine the efficacy and safety of radiofrequency volumetric thermal ablation (RFVTA) of symptomatic uterine fibroids in premenopausal women with symptomatic uterine fibroids and objectively confirmed heavy menstrual bleeding. Patients in this prospective, interventional clinical trial are women who had ≤ 6 treatable fibroids with no single fibroid exceeding 7 cm in any diameter, had a minimum of a three-month history of heavy menstrual bleeding within six months of enrollment, and desired uterine conservation. Outcome measures included: patient responses to validated questionnaires, treatment-emergent adverse events, and surgical re-intervention for fibroids at 24 months post-procedure. Comparisons between visits were based on t-tests using repeated measures models. Twelve- and 24-month outcomes from the Halt Trial have been reported in the literature. Data presented at AAGL analyze the clinical success of RFVTA of symptomatic uterine fibroids at two years of follow up.
About the Acessa Procedure
The Acessa procedure is a minimally-invasive, same-day (outpatient) therapy for fibroids of all types and sizes, in all locations within and outside of the uterine wall. It uses a technology called radiofrequency volumetric thermal ablation. Each fibroid is destroyed by applying energy through a small needle array. The surrounding normal tissue is not affected. The destroyed tissue may then be completely reabsorbed and the uterus remains intact.
About Halt Medical, Inc.
Founded in 2004, Halt Medical is a medical device company focused on establishing a new standard of care for women with symptomatic uterine fibroids. The Company has developed and launched the Acessa System and Procedure, using radiofrequency energy to destroy uterine fibroids. The results of both U.S. and international trials have led to the clearance of the product by the FDA for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance. The Acessa System also has regulatory approval to treat symptomatic uterine fibroids in the European Union, Canada, and Mexico. The Company is located in Brentwood, CA. For information about the Acessa System, please visit www.haltmedical.com. To connect with Halt Medical on Facebook visit www.facebook.com/acessasystem or on Twitter at www.twitter.com/acessasystem.
SOURCE Halt Medical, Inc.