Gynesonics, a women’s healthcare company focused on the development of minimally-invasive solutions for symptomatic uterine fibroids, announced today the full launch of the Sonata® 2 System in the United States and Europe at the American Association of Gynecologic Laparoscopists (AAGL) Conference, in Vancouver, BC, Canada, from November 10-13. The Sonata System is the world’s first and only transcervical fibroid ablation system that combines the first ever intrauterine ultrasound guidance with the proven benefits of targeted radiofrequency energy in an incisionless, uterus preserving procedure.

The Company also announced that it had completed the first patients treated with the new Sonata 2 System in the U.S. with now more than 1,000 patients treated globally.

The new Sonata 2 System features a next-generation intrauterine ultrasound probe that has improved performance and durability, providing higher resolution imaging for targeting of fibroids throughout the uterus. The new system also includes an improved graphic user interface that enhances workflow efficiency and the overall user experience.

The long-term 2-year Outcomes Data for the SONATA FDA IDE Pivotal Trial will be presented in a plenary session on Monday, November 11 at the AAGL conference. The data will reveal sustained symptom relief with patients showing a significant improvement in quality of life and reduction in severity of symptoms through two years, with a low rate of reintervention. These data were recently published in the Journal of Gynecologic Surgery.

The long-term efficacy of the Sonata System is further supported by the positive 5-year outcomes data reported in the VITALITY study published earlier this year in the Journal of Gynecologic Surgery. These long-term data follow the impressive early clinical results in the SONATA pivotal trial where 95% of patients had a reduction in their bleeding symptoms with a 97% patient satisfaction rate at 12 months. A growing body of clinical evidence substantiating the significant patient benefits and long-term efficacy of Sonata includes 24 peer-reviewed publications to date, with three-year results for the SONATA FDA IDE Pivotal Trial expected to be published in 2020.

Scott Chudnoff, M.D., MSc, FACOG, Chair of the Department of Obstetrics and Gynecology, Stamford (CT) Health, performed several procedures as a trial investigator in the SONATA FDA IDE pivotal trial and performed the first case with the Sonata 2 System in the U.S. “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,” said Dr. Chudnoff. “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.”

Gregory Shifrin, M.D., FACOG, Surgery of Tomorrow, Brooklyn, N.Y., has also performed several commercial cases of the Sonata 2 System in the U.S. “I find the Sonata technology and technique to be straightforward in treating a wide range of fibroid types and sizes,” Dr. Shifrin said. “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.”

Source: Company Press Release