Impressive 12-Month Patient Outcomes from SONATA Pivotal IDE Trial Being Highlighted
Redwood City, CA – Nov 12, 2018 – Gynesonics, a women’s healthcare company focused on the development of advanced minimally invasive solutions for the treatment of uterine conditions, today announced that its Sonata® System for transcervical treatment of uterine fibroids will be featured in several presentations in the scientific program at the 47th Annual American Association of Gynecologic Laparoscopists (AAGL) Global Congress November 11-15 at the MGM Grand Conference Center in Las Vegas, Nevada.
The AAGL is the leading association promoting minimally invasive gynecologic surgery among gynecologists worldwide. Its membership extends to more than 110 countries and more than 7,000 members globally. The presentations regarding the Sonata System will include clinical outcomes from the SONATA Pivotal IDE Trial and three additional clinical research studies completed in 2018 with the Sonata System, an incisionless treatment for uterine fibroids that preserves the uterus.
The Sonata System received FDA clearance in August. Gynesonics President and CEO Christopher M. Owens commented: “This data is central to our clinical evidence strategy to support our market development objectives, including our global reimbursement strategy. This AAGL Congress is a terrific opportunity to market our technology in the US for the first time and for physicians to see the impressive clinical outcomes.” “The SONATA Pivotal Trial clearly demonstrates significant patient benefits, including; improvement in fibroid symptoms and quality of life, a brief length of stay and rapid return to normal activity.
The trial also demonstrated the Sonata System can treat a broader range of fibroid types (including; submucous, intramural, transmural and subserous) than current transcervical methods. We are building upon these impressive results with an additional nine studies that are in process or have been completed, of which three are also being presented at this Congress,” Owens added. “Gynesonics will continue to support the clinical research essential to our overall market development objectives, thereby ensuring access for patients globally to this breakthrough incisionless, transcervical option for the treatment of symptomatic uterine fibroids.”
Topics and presenters include:
Open Communications • New Instruments • Room: 121-122
● 2:15 PM – Michael Moore, MD – A Comparison of Pain Scores in Patients Undergoing Transcervical Radiofrequency Ablation of Uterine Fibroids Under General Anesthesia or Conscious Sedation in the SONATA Pivotal IDE Trial. Received Daniel Kott Award for New Instrumentation or Technology.
● 2:22 PM – David Levine, MD – Improvement in 12-month Health-related Quality of Life and Work Productivity After Ultrasound-guided Transcervical, Intrauterine Radiofrequency Ablation of Uterine Fibroids in the SONATA Pivotal IDE Trial.
● 2:29 PM – Richard Guido, MD – 12-Month Patient-Reported Outcomes of the SONATA Pivotal IDE Trial: Sonography-Guided Transcervical Radiofrequency Ablation of Uterine Fibroids.
● 2:36 PM – Scott Chudnoff, MD – 12-Month Primary Clinical Endpoints and Safety Analysis of the SONATA Pivotal IDE Trial: Sonography-Guided Transcervical Radiofrequency Ablation of Uterine Fibroids.
● 2:54 PM – José G. Garza-Leal, MD – Preservation of Myometrial Integrity 12 Months After Transcervical Radiofrequency Ablation with the Sonata® System: Results from the FAST-EU Clinical Trial. Recognized as Best Abstract.
Poster authors will be available at the time provided below. The posters will be available for viewing during exhibit hours on November 13-14.
Virtual Poster Session 1
● 10:25 AM – Kelly Roy, MD – 12-Month Procedural Outcomes of the SONATA Pivotal IDE Trial: Sonography-Guided Transcervical Radiofrequency Ablation of Uterine Fibroids. Virtual Poster Session 3
● 10:25 AM – José G. Garza-Leal, MD – Five-Year Clinical Outcomes of Transcervical Radiofrequency Ablation of Uterine Fibroids with the Sonata System: The VITALITY Clinical Trial.
● 10:25 AM – Joseph Hudgens, MD – Sonography-Guided Transcervical Radio-frequency Ablation of Uterine Fibroids (the SONATA Pivotal IDE Trial): Reduction in Menstrual Blood Loss in Women with Indenting/Abutting Fibroids.
● 10:25 AM – Ralf Bends, MD – Normal Spontaneous Vaginal Delivery after Transcervical Radiofrequency Ablation of Uterine Fibroids: Case Report.
Plenary Session 7 • Reproductive Issues • Room 111-112
● 2:35 PM – Stephen Quinn, MD – Clinical Outcomes of the OPEN Clinical Trial: Evaluation of Uterine Patency Following Sonography-Guided Transcervical Radiofrequency Ablation of Fibroids with the Sonata® System.
About Sonata System
The Sonata System, the next generation of Gynesonics’ technology platform (the previous generation referred to as VizAblate), uses radiofrequency energy to ablate fibroids under intrauterine sonography guidance. The Sonata System, including the SMART Guide, enables the operator to target fibroids and optimize ablations within them. Sonata system’s design provides a straightforward, transcervical access for a uterus preserving, incision-free fibroid treatment. This intrauterine approach is designed to avoid the peritoneal cavity.
Gynesonics is a women’s healthcare company focused on advancing women’s health, by developing minimally invasive, transcervical, uterus-preserving, incision-free technologies for diagnostic and therapeutic applications. Gynesonics has developed the Sonata System for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids. The Sonata System is CE marked. Sonata is approved for sale in the European Union and the United States. Gynesonics is a privately held company with headquarters in Redwood City, CA. For more information, go to www.gynesonics.com.
CONTACT: Chris Owens Gynesonics President and CEO +1.650.216.3860 www.gynesonics.com