Gynesonics touts 5-year data from its uterine fibroid ablation treatment

2014 Fierce 15 company Gynesonics has unveiled long-term follow-up data, spanning more than five years, that tracks the durability of its incisionless ablation treatment for uterine fibroids. The study showed that no surgical reinterventions were needed in the first 3.4 years following treatment with the company’s Sonata system, with an annualized reintervention rate of 2.2%. Cumulatively—over the study’s average follow-up of 5.4 years in 17 patients—the reintervention rate reached 11.8%. In addition, scores of symptom severity and quality of life improved by an average of 37 points and 49 points, respectively. The full results were published in the Journal of Gynecologic Surgery. Gynesonics’ Sonata system—the next generation of its VizAblate platform—combines unique intrauterine ultrasound guidance and imaging system with a radiofrequency ablation device. The system received 510(k) approval from the FDA last August for the transcervical treatment of symptomatic uterine fibroids, also known as leiomyomas, including those associated with heavy menstrual bleeding.