Gynesonics® announced today that its Sonata System for Transcervical Fibroid Ablation (TFA) is an important technology for medical facilities and practitioners as they consider restarting and maintaining elective fibroid procedures following restrictions due to the COVID-19 pandemic. Sonata integrates the first and only intrauterine ultrasound system with a proprietary advanced radiofrequency ablation device to treat symptomatic fibroids in a transcervical, incision-free, uterus-preserving manner.
The Sonata technology was one of the first gynecological procedures performed by Dr. Ladina Christoffel at Spital Oberengadin – Schweiz (Samedan, Switzerland) following the lifting of her hospital’s restrictions of elective cases. “The outpatient setting and short hospital stay associated with the Sonata TFA treatment minimizes patient exposure related to treatment, and frees up precious operating room time for us to be able to treat more fibroid patients with Sonata in a single day compared to the other options like myomectomy or hysterectomy. The clinical and procedural advantages provided by Sonata to fibroid patients are even more obvious in a patient backlog situation, as caused by the pandemic,” said Dr. Christoffel.
Sonata System is typically utilized in an outpatient setting or ambulatory surgery center (ASC) and does not require a hospital inpatient admission. The clinical data for Sonata clearly demonstrate advantages in the length of stay and recovery; it allows for minimal time to discharge, short length of stay, has quick recovery, and delivers an excellent safety profile; there have been no device-related adverse events in clinical studies of the Sonata System. Studies also show that 50% of women return to normal activities the next day. As a transcervical procedure, TFA is incisionless and does not require general anesthesia; in the SONATA pivotal trial, half of the patients were treated under conscious sedation. Sonata is not a laparoscopic procedure, therefore it avoids the peritoneal cavity and the potential risk to healthcare personnel from pneumoperitoneum or aerosolization of virus particles.
“Fibroid ablation with the Sonata System enables gynecologists to treat fibroids transcervically, conserving a woman’s uterus, while delivering an efficient and straightforward incision-less procedure,” said David Toub, M.D., M.B.A., FACOG, Medical Director at Gynesonics. “Sonata will be an important technology in support of the resumption of elective fibroid procedures in the wake of the COVID-19 pandemic. This is due to the characteristics of the TFA procedure itself, which is performed on an outpatient basis (including within ambulatory surgical centers) and is associated with a short length of stay of 2.5 hours, inclusive of procedure time. Transcervical fibroid ablation with Sonata is thus consistent with guidance from major obstetrics and gynecology societies, such as the American Association of Gynecologic Laparoscopists (AAGL), the Society of Gynecologic Surgeons (SGS) and the European Society for Gynaecological Endoscopy (ESGE), to minimize blood/fluid droplet spray or spread, prefer regional anesthesia or conscious sedation, and reduce the patient’s time in the hospital or ASC setting, minimizing her exposure to healthcare providers.”
“The clinical and procedural benefits of the Sonata system provides a compelling value proposition for all stakeholders and may be an important technology in restarting and maintaining elective procedures for facilities impacted by the effects of the COVID-19 pandemic,” said Christopher Owens, President & CEO of Gynesonics.
Dr. Kelly Roy, founder and owner of Arizona Gynecology Consultants and a SONATA clinical trial investigator, has restarted performing TFA cases at her ambulatory surgery center. “My patients appreciate the benefits of an incisionless fibroid treatment option that minimizes risk, procedure time and length of stay. Our staff also appreciates that patients being treated with Sonata can be quickly and safely discharged, posing less risk to them since they don’t need intubation and are not undergoing a laparoscopic procedure that might aerosolize the SARS-CoV-2 virus. Our patients have also been pleased with the long-term benefits provided by the Sonata treatment. These factors all contribute to why we prioritized patients desiring Sonata when restarting elective procedures.”
With an estimated volume of more than 1 million annual global fibroid procedures, Gynesonics projects a greater than $4 billion global market opportunity for its Sonata System for the treatment of uterine fibroids, including a market opportunity of more than $1 billion in the U.S. alone. Sonata is the only technology that can treat up to 80% of fibroid types transcervically.