Gynesonics, a Redwood City, CA firm, won clearance from the FDA for its Sonata (Sonography-Guided Transcervical Fibroid Ablation) System. The device already has the CE Mark clearing it for sale in Europe.
The Sonata combines ultrasound visualization with a proprietary ablation device to allow for transcervical, incisionless removal of most intrauterine fibroids. Currently, only a small portion of diagnosed fibroids are removable using the transcervical approach.
The system comes with its own software that helps to plan and execute procedures with confidence. The software shows the tissue area, including size and location, that would be affected by the RF energy before the ablation begins. The physician can use this to target the tissue as well as set the length and energy level of the ablation, as well as position mechanical stoppers to avoid moving the introducer and needle electrode too far in.
Product page: Sonata System…
Via: Gynesonics…