"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
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