New CPT code established for Gynesonics‰Ûª Sonata system


The American Medical Association (AMA) Current Procedure Terminology (CPT) Editorial Panel has established a new AMA CPT code specifically for transcervical uterine fibroid ablation with ultrasound guidance. Gynesonics applied for the new code, which was presented to the Editorial Panel in February.

CPT codes are used by medical practitioners including physicians, hospitals, and other healthcare providers, to report healthcare services to insurers for the purpose of reimbursement. This standardised nationwide system of identification provides a uniform language for reporting medical services.

The code has the following descriptor: Transcervical uterine fibroid(s) ablation with ultrasound guidance, radiofrequency. The announcement was posted and made available on the AMA website. The final code number will be released at a future date and will become effective on 1 January 2016.

The Sonata system from Gynesonics provides a uterus preserving, incision-free treatment option to women suffering from symptomatic uterine fibroids, including those associated with heavy menstrual bleeding. Sonata combines and integrates a high resolution, compact ultrasound probe at the tip of a radio frequency ablation device to provide a single handheld transcervical treatment delivery system under integrated sonographic guidance.

Gynesonics president and chief executive officer Christopher M Owens noted that the company pursued the Category III designation in conjunction with beginning its pivotal investigational device exemption (IDE) Sonata trial.

“This initiative provides us the opportunity to establish a dialogue with the AMA CPT Editorial Panel, the gynecology societies and their advisors to ensure proper procedure coding, while completing our Food and Drug Administration (FDA) Sonata IDE trial,” Owens, said. “Widespread reimbursement coverage for the Sonata technology is essential to making it available to women with fibroids who can benefit from its application. In addition to the FDA IDE Sonata trial, the company will continue to move forward with additional clinical and health economics and outcomes research trials. Our intention is to pursue reimbursement coverage and a migration to a CPT Category I code for the Sonata system upon FDA clearance.”