Gynesonics touts fibroid study ’ s long-term outcomes

A long-term retrospective study of patients treated with Gynesonics’ Sonata uterine fibroid treatment system revealed low rates of surgical reintervention, improved symptom severity and quality of life, the company said today. Patients at the study site in Monterrey, Mexico were treated with the Sonata system, designed to provide incisionless transcervical radiofrequency energy ablation of uterine fibroids under intrauterine ultrasound guidance. The mean follow-up period for the patients enrolled was 5.4 years. Highlights from the study include: No surgical reinterventions in the first 3.4 years. Annualized surgical reintervention rate per year of 2.2%. 11.8% cumulative reintervention rate through 5.4 years average follow-up. 37 point mean improvement in symptom severity score at follow-up. 49 point mean improvement in health-related quality of life at follow-up. “We have evaluated many new fibroid treatment innovations in our facility and are especially impressed with the patient results achieved with Sonata over this extended time frame,” said Jose Gerardo Garza-Leal, M.D., of the Universidad Autonoma de Nuevo Leon in Monterrey in a prepared statement from Gynesonics. “Such lasting results are even more impressive considering the low risk and quick recovery our patients experienced with the Sonata procedure, especially when compared to other fibroid treatment alternatives.” Redwood City, Calif.-based Gynesonics said its Sonata system platform provide...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog Clinical Trials Gynecological Imaging News Well Ultrasound Women's Health FDA Gynesonics Source Type: news