Gynesonics has announced the full U.S. and European launch of its Sonata 2 transcervical fibroid ablation system for incisionless, uterus-preserving procedures.
The Sonata 2 system is the world’s first and only transcervical fibroid ablation system to combine intrauterine ultrasound guidance with targeted radiofrequency energy in the incisionless procedure, according to a Nov. 11 news release.
Redwood City, Calif.–based Gynesonics’ Sonata 2 system uses a next-generation intrauterine ultrasound probe designed to provide higher resolution imaging for the targeting of fibroids throughout the uterus. They system also has an improved graphic user interface to improve workflow and user experience, according to the release.
In January of this year, Gynesonics announced that it raised $75 million in an equity financing round to support the Sonata 2 system.
A study of five-year outcomes from the company’s Vitality study published earlier this year revealed that 95% of patients had a reduction in their bleeding symptoms and 97% reported patient satisfaction at 10 months. Gynesonics expects the three-year results from its Sonata FDA investigative device exemption pivotal trial to be published in 2020.
On top of the launch, the company announced that it completed the first patient treatment with the new Sonata 2 system in the U.S., as more than 1,000 patients have already been treated around the world.
Stamford Health (Stamford, Conn.) chair of obstetrics & gynecology Dr. Scott Chudnoff performed the first U.S. Sonata 2 case, and Dr. Gregory Shifrin of Surgery of Tomorrow (Brooklyn, N.Y.) has also performed commercial cases of the Sonata 2 system.
“We have always been looking to give women options that go beyond removing her entire uterus to alleviate the many painful and challenging symptoms caused by fibroids,” Chudnoff said in the release. “Now with the use of the Sonata technology, we can perform a same-day procedure that not only avoids a hysterectomy, but also eliminates having to make any incision at all, so this really is a game-changer for women who suffer with fibroids.”
“I find the Sonata technology and technique to be straightforward in treating a wide range of fibroid types and sizes,” added Shifrin. “This is an exciting new incision-free uterus preserving treatment option for my patients who want to resolve their symptoms but prefer to avoid traditional surgery.”