Sonata system in use. (Image courtesy of Gynesonics.)
Women’s healthcare company Gynesonics (Redwood City, Calif.) said it has received 510(k) clearance from the FDA to market its Sonata sonography-guided transcervical fibroid ablation system.
Sonata combines a breakthrough integrated technology — the first intrauterine ultrasound system — with a proprietary radiofrequency ablation device, providing a transcervical, incision-free, uterus-preserving treatment for uterine fibroids, the company said in a statement.
With an estimated volume of more than 1 million annual global fibroid procedures, Gynesonics projects a $3 billion-$4 billion global market opportunity for Sonata, including a market opportunity of more than $1 billion in the U.S. alone.
“We are excited to announce FDA clearance of our Sonata system. This is an essential milestone for Gynesonics in our mission to bring this transformational technology for the treatment of uterine fibroids to women,” Gynesonics president & CEO Christopher Owens said in the statement. “The patient outcomes achieved with Sonata demonstrate its potential to become a new standard of care in fibroid treatment, providing important patient benefits as compared to invasive surgery. Clinical trial outcomes show that Sonata provides a significant and durable improvement in symptoms with more than half the women returning to normal activities within 24 hours.”
Although they may not cause symptoms in many cases, fibroids can lead to heavy menstrual bleeding, infertility, miscarriage and early onset of labor. Hysterectomy is an effective treatment, but many uterine-sparing options are available, according to the National Institutes of Health (NIH). Current transcervical options are limited to treatment of a small portion of the total fibroid market by comparison, according to Owens.
Most U.S. women will develop fibroids at some point in their lives, according to the NIH. Eighty percent of African American women and 70% of white women had fibroids by age 50, the NIH said, citing a 2003 American Journal of Obstetrics and Gynecology article.
A survey of 968 women affected by fibroids, published in the same journal in 2013, found that 79% want to avoid invasive surgery, most wait an average of 3.6 years before seeking treatment, and most also want to preserve their uterus.
Gynesonics exceeded the FDA-specified 12-month primary endpoint performance requirements for the Sonata system used to support the FDA regulatory 510(k) filing, the company said. The co-primary endpoints in the pivotal IDE clinical trial included a significant reduction in bleeding and a high rate of freedom from surgical reintervention due to heavy menstrual bleeding. The safety outcomes included zero device-related adverse events reported in the 147-patient trial, the company noted.
The Sonata system also holds the CE Mark.
