REDWOOD CITY, Calif., Jan. 02, 2024 (GLOBE NEWSWIRE) -- Gynesonics®, Inc. a privately-held women’s healthcare medical device company focused on the development of minimally invasive solutions for symptomatic uterine fibroids, announced today that with the support of the American College of Obstetrics and Gynecology (ACOG), the American Medical Association (AMA) has established a new Current Procedural Terminology (CPT®) Category I code, 58580, for transcervical uterine fibroid(s) ablation with ultrasound guidance using radiofrequency. The AMA CPT Editorial Panel agreed that this service meets the criteria for a Category I assignment based on the procedure being consistent with current medical practice, and where the clinical efficacy of the procedure is documented in literature that meets the AMA CPT requirements.
The new code is effective January 1, 2024, and is defined as CPT 58580 Transcervical ablation of uterine fibroid(s), including intraoperative ultrasound guidance and monitoring, radiofrequency.
CPT codes are used by medical practitioners to report healthcare services. This standardized nationwide system of identification provides a uniform language for reporting medical services and has been used by Medicare, Medicaid, and Commercial plans for more than half a century.
Commenting on the new CPT code, Skip Baldino, President and Chief Executive Officer of Gynesonics said, “We are very pleased that the AMA has established a new Category I code that applies to our Sonata® Procedure for the treatment of uterine fibroids. This unique code will simplify the process for providers and insurers of submitting and processing claims on behalf of their patients. The code is a critical milestone for the broader adoption of the technology to treat uterine fibroids in the United States. We sincerely appreciate the efforts of the AMA and the CPT Editorial Panel to establish a Category 1 code, acknowledging the innovation and efficacy of the Sonata transcervical fibroid ablation.”
Uterine fibroids are benign masses in or around the uterus. They are common and most women develop them during childbearing age. Symptoms of fibroids include abnormal uterine bleeding, abdominal pelvic pain or pressure, increased abdominal girth, urinary frequency, constipation, preterm labor, and painful intercourse.
The Sonata System is a technology platform that integrates the first and only commercial intrauterine ultrasound system with a proprietary advanced radiofrequency ablation device, providing an incision-free, uterus-preserving, transcervical treatment for symptomatic uterine fibroids. The Sonata Procedure is a breakthrough alternative to hysterectomy and myomectomy, and can treat a wide range of fibroid types, sizes, and locations. Fibroids are treated from inside the uterus, so the Sonata Procedure requires no incisions, no tissue is surgically removed, and the uterus is preserved.
About the Sonata System
The Sonata System is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding. Common Side Effects include bleeding, spotting, cramping, post-ablation inflammatory symptoms, and/or discharge. There are potential risks with this treatment such as skin burn and infection. Women who are pregnant, have a pelvic infection, are known to have gynecologic cancer, or have intratubal implants for sterilization should not have this procedure.
The Sonata System is CE marked and is approved for sale in the European Union, the United Kingdom, Switzerland, and the United States. For more information on Sonata, please visit us at www.sonatasystem.com.
About Gynesonics
As pioneers in women’s health, Gynesonics is committed to developing and delivering minimally invasive, incision-free, uterus-preserving, transcervical technologies for diagnostic and therapeutic applications. Our flagship product, the Sonata System, is the first FDA cleared medical device for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids. Gynesonics headquarters is in Redwood City, CA. For more information, go to www.gynesonics.com.
Company Contact:
Tara Murphy, Senior Director, Global Marketing & Advocacy, Gynesonics, tmurphy@gynesonics.com, (215) 620-3004
Media Contact:
David Gutierrez, Dresner Corporate Services, dgutierrez@dresnerco.com, (312) 780-7204
