Gynesonics Announces FDA Clearance for Next Generation Sonata System

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The only incisionless transcervical system for radiofrequency ablation of fibroids offers new benefits with features such as an increased range of ablation sizes, a new user interface and the validation of additional low temperature hospital reprocessing systems

REDWOOD CITY, Calif .– (BUSINESS WIRE) – Gynesonics®, a women’s healthcare company focused on developing minimally invasive solutions for symptomatic uterine fibroids, today announced that the Food and Drug Administration ( FDA) has cleared the Sonata® System 2.2 which offers significant new benefits for facilities, physicians and patients. These benefits include: a 20% reduction in the smallest ablation size, which significantly increases the ability to treat fibroids in narrower anatomical locations; new software advances that allow the surgeon to control all aspects of the ablation from the handpiece without the operating room staff having to adjust parameters separately; and changes that allow the surgeon to adjust all ultrasound parameters directly from the sterile field. The system includes a new reusable cable. In addition, the new reusable intrauterine ultrasound probe is now validated for sterilization using the STERIS V-PRO® family of low temperature sterilization systems, commonly available in hospitals.

“This clearance brings significant system improvements that expand the location of fibroids that can be treated while allowing the physician to control all aspects of treatment from the sterile field,” said Jiayu Chen, Ph.D. Vice President , Engineering and advanced technologies at Gynesonics. “These changes are of real benefit to treating physicians and to more women seeking relief from their symptoms caused by fibroids. In addition, the ability to use the widely available range of STERIS V-PRO low temperature sterilization systems and the remarkable technical achievements of the new reusable RF handpiece cable provide cost advantages for facilities and reduce costs. procedural waste. This is a positive step forward for women, doctors and medical center facilities.

The Sonata technology platform integrates the first and only commercial intrauterine ultrasound system with a proprietary advanced radiofrequency ablation device, providing transcervical treatment without incision and preserving the uterus for symptomatic uterine fibroids. Sonata treatment is a revolutionary alternative to hysterectomy and myomectomy, and can treat a wider range of fibroid types, sizes and locations than hysteroscopic myomectomy. Fibroids are treated from the uterus, so treatment with the Sonata System does not require any incisions, no tissue is surgically removed, and the uterus is retained.

“Gynesonics has a long and successful history of significant innovation and change that has real benefits for the healthcare system and for the patient. The new Sonata System 2.2 is a continuation of this commitment to innovation. The timing of this clearance coincides with Sonata’s accelerated application, ”said Chris Owens, President and CEO of Gynesonics. “The new system offers better functionality, ease of use and flexibility to physicians who want to offer Sonata TFA to their patients and to the millions of women who have been waiting for an option that does not require invasive incisional surgery.

For more information on the Sonata system, visit www.gynesonics.com.

About the Sonata system

The Sonata System uses radiofrequency energy to remove fibroids under real-time ultrasound guidance from inside the uterine cavity, using the first and only intrauterine ultrasound transducer. The system includes a proprietary graphical user interface (SMART Guide), allowing the operator to target fibroids and optimize treatment. The Sonata System provides incision-free transcervical access for the treatment of uterine-preserving fibroids. This intrauterine approach is designed to avoid the peritoneal cavity. Most side effects are usually minor and temporary. The Sonata system is CE marked and approved for sale in the European Union, United Kingdom, and United States.

About fibroids

Fibroids are benign growths in or around the uterus. They are common and most women develop them during their childbearing years. In the United States, about 70% of white women and over 80% of black women will have uterine fibroids by the age of 50. Problematic fibroids can vary in size from a raisin to a grapefruit, and symptoms can worsen over time if the fibroids are left untreated. 20% to 50% of women with fibroids are symptomatic and each year in the United States, more than 2 million women undergo treatment for uterine fibroids. Women with symptomatic fibroids may have one or more of the following:

  • Abnormal uterine bleeding / menorrhagia

  • Abdominopelvic pain / pressure

  • Increase in abdominal circumference

  • Urinary frequency

  • Constipation

  • Subfertility

  • Pregnancy complications

  • Dyspareunia (painful intercourse)

About gynecology

Gynesonics is a women’s healthcare company focused on improving women’s health by developing minimally invasive, incisionless, uterine-preserving transcervical technologies for diagnostic and therapeutic applications. Gynesonics developed the Sonata system for intrauterine diagnostic imaging and transcervical treatment of symptomatic uterine fibroids. Gynesonics headquarters are in Redwood City, California. For more information, visit www.gynesonics.com.

Company details :

Kelly Petrucci, Vice President Global Strategy and Market Access, Gynesonics, [email protected]

Media contact:

David Gutierrez, Dresner Corporate Services, [email protected], (312) 780-7204

Source: Gynetics


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