…a clinically proven, minimally invasive, day-case treatment for symptomatic uterine fibroids
Gynesonics, a global medical technology company specialising in women’s health, has launched the Sonata System – a transcervical fibroid ablation system that uses radiofrequency (RF) energy for the treatment of symptomatic uterine fibroids. Sonata is the ONLY treatment option for uterine fibroids that integrates imaging guidance (ultrasound) and therapy (radiofrequency) into a single, handheld delivery system to locate and target individual fibroids. Sonata is an innovative and safe alternative to more invasive treatment options such as myomectomies and hysterectomies.
Approximately 600,000 women undergo surgical interventions for fibroids in Europe and the US5 and a recent survey revealed that women with uterine fibroids, on average, delay seeking treatment for 3.6 years, with 79 per cent wanting to avoid invasive surgery that can require lengthy recoveries.1 Interestingly, hysterectomies and myomectomies are the most common treatment approaches for uterine fibroids, despite hysterectomies not retaining the uterus and both operations requiring invasive surgery and longer recovery times.
TREAT SMARTER WITH SONATA
The new Sonata System uses an intrauterine ultrasound probe and RF device, which is delivered via one, integrated handpiece through the vagina and cervix into the uterus to ablate uterine fibroids, causing them to shrink and relieve symptoms for patients. The fibroids are treated from inside the uterus, so the Sonata Treatment requires no abdominal incisions, no tissue is cut or surgically removed, and the uterus is preserved.
“Uterine fibroids affect 1 in 3 women in the UK and can adversely impact upon a woman’s quality of life because of debilitating heavy menstrual bleeding, painful periods and pressure symptoms.4 Increasingly effective medical and minimally invasive treatments would be widely welcomed by women and their healthcare professionals,” said Professor Justin Clark, president of the British Society for Gynaecological Endoscopy.
“We’re encouraging healthcare professionals to #TreatSmarterWithSonata, in order to improve clinical outcomes for their patients and deliver significant cost efficiencies for healthcare organisations,” added the Medical Director of Gynesonics, Dr David Toub, FACOG.
The CE-marked Sonata System offers a treatment as a day case procedure and is associated with procedural safety and durable clinical outcomes.5,6 Transcervical fibroid ablation does not often require general anaesthesia and could be performed in the outpatient clinic, thus providing a quick recovery for patients. A single fibroid ablation takes between 2-7 minutes.
Most fibroid types can be ablated, namely all nonpedunculated submucous, intramural, transmural and subserous fibroids, and the Sonata System ablation zone can be adjusted to precisely ablate fibroids of various sizes. Sonata’s innovative SMART Targeting Guide displays a real-time graphic overlay on the live ultrasound image and is designed to optimise the ablation area with a focus on patient safety. The graphic overlay determines the size and location of the ablation zone and thermal safety border, and the duration of radiofrequency energy delivery is a function of the selected ablation dimensions. The focus is on a safe and effective ablation procedure.
As well as the brief recovery time, the long-term outcomes for patients are established, with 99.3 per cent of patients needing no surgical reintervention within 12 months of treatment with Sonata.2 About ninety per cent of patients reported a reduction in menstrual bleeding within three months of having a Sonata treatment, and 95 per cent within 12 months. 2.3
HOW THE NEW SONATA SYSTEM WORKS
1. The Sonata treatment device is passed through the vagina and into the uterus
2. Ultrasound waves from the Intrauterine Ultrasound Probe are used to locate the fibroid
3. The Sonata device delivers radio frequency energy to shrink the fibroid
4. The device is repositioned to treat additional fibroids or removed from the patient
To learn more about the new Sonata System, please visit www.treatsmarterwithsonata.co.uk
About the Sonata® System
The Sonata System uses radiofrequency energy to ablate fibroids under real time intrauterine sonography guidance. The Sonata System, including the SMART Guide, enables the operator to target fibroids and optimise ablations within them. The 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. The Sonata System is CE marked. Sonata is approved for sale in the European Union and the United States. For Indication and Safety Information, or to learn more about the Sonata System, visit www.treatsmarterwithsonata.co.uk.
About Gynesonics
Gynesonics is a women’s healthcare company focused on advancing women’s health, by developing minimally invasive, incision-free, uterus-preserving, transcervical technologies for diagnostic and therapeutic applications. Gynesonics has developed the Sonata System for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids. For more information, go to www.gynesonics.com.
Gynesonics, Sonata, and the logos are trademarks and registered trademarks of Gynesonics, Inc. Gynesonics products are covered by US and foreign patents. See www.gynesonics.com/us/patents.
References
1. Borah BJ, Nicholson WK, Bradley L, Stewart EA. The impact of uterine leiomyomas: a national survey of affected women. Am J ObstetGynecol. Oct 2013;209(4):319 e1-319 e20.
2. Brölmann H, Bongers M, Garza-Leal JG et al. The FAST-EU trial: 12-month clinical outcomes of women after intrauterine sonography-guided transcervical radiofrequency ablation of uterine fibroids. Gynecol Surg. 2016;27-35.
3. Chudnoff, S., Guido, R., Roy, K., Levine, D., Mihalov, L. and Garza-Leal, J.G., 2019. Ultrasound-guided transcervical ablation of uterine leiomyomas. Obstetrics & Gynecology, 133(1), pp.13-22.
4. https://www.nhs.uk/conditions/fibroids/
5. Miller CE, Osman KM. Transcervical Radiofrequency Ablation of Symptomatic Uterine Fibroids: 2-Year Results of the SONATA Pivotal Trial. J Gynecol Surg. 2019;35:345-349.
6. Garza-Leal JG. Long-Term Clinical Outcomes of Transcervical Radiofrequency Ablation of Uterine Fibroids: The VITALITY Study. Journal of Gynecologic Surg. 2019; 35:19-23.
