The FDA has granted 510(k) clearance to Gynesonics’ sonography-guided transcervical fibroid ablation system, called Sonata, the company said Wednesday.
Sonata features an ultrasound probe and radiofrequency emitter to enable physicians to visualize and reduce the volume of uterine fibroids.
Gynesonics secured the clearance after 94% of women treated with the transvaginal device in a pivotal trial experienced a reduction in bleeding.
Research suggests most women develop uterine fibroids before menopause. These benign tumors are often asymptomatic but have the potential to cause symptoms, including abnormal uterine bleeding, that negatively affect quality of life.
Yet, driven by a desire to avoid invasive surgery and preserve their uterus, many women live with these symptoms for years.
Allergan developed a drug, Esmya, to provide a nonsurgical option but it has been dogged by safety concerns and regulatory setbacks. Esmya came to market in Europe only for regulators to restrict its use after identifying a link to liver injury. The FDA rejected a filing for approval of Esmya this week.
Gynesonics thinks its solution Sonata is a workable alternative to invasive surgery and pharmacological treatment. The device enters the body through the cervix, eliminating the need to make an incision. Once inside the body, the device sends ultrasound images to the physician performing the procedure. These images enable the physician to see the uterine fibroids. Having identified a fibroid, the physician can apply radiofrequency energy to ablate the tumor and reduce its size.
The first generation of the device, which was formerly known as VizAblate, came to market in Europe around the start of the decade but progress in the U.S. has lagged well behind. Gynesonics began a pivotal, single-arm trial at U.S. sites in 2014 and presented data in January. The trial linked the device to a reduction in bleeding in 94% of patients. Almost none of the 147 participants needed surgical re-intervention for heavy menstrual bleeding due to the failure of the treatment.
Those results proved compelling enough to secure Gynesonics a 510(k) clearance. The question now is whether it can carve out a commercial niche among a field of rival, noninvasive approaches to the treatment of uterine fibroids. Other options available to women include Boston Scientific’s Embozene and Insightec’s MRgFUS.