By: 1 July 2020
Introducing the new Gynesonics Sonata® System for performing incision-free transcervical fibroid ablation

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July is World Fibroid Awareness Month, so it seems appropriate to focus for a moment on just how many women are affected by this condition and the symptoms they may experience. Uterine fibroids are in fact a common problem affecting 1 in 3 of the UK’s female population [1]. Typical symptoms include pelvic pain, urinary problems and heavy bleeding, all of which can have a severe impact on a patient’s physical and mental wellbeing [1].

Approximately 600,000 women undergo surgical interventions for uterine fibroids in Europe and the US [2]. This is often after having waited more than 3.5 years before seeking treatment, according to a recent survey [3]. The survey also revealed that 79% wanted, where possible, to avoid invasive surgery that can require a lengthy recovery time [3].

Gynesonics’ Sonata® System is the only treatment option for uterine fibroids that integrates imaging guidance (ultrasound) and therapy (radiofrequency energy) into a treatment device to locate, target and treat individual fibroids.

Sonata System cart

Sonata System cart

What common treatments are currently available?

Medical / hormonal therapy
Medications and hormones that may be prescribed do not eliminate fibroids, but can treat the symptoms and in some cases, shrink the fibroids temporarily. They can also cause some undesirable side effects, such as triggering a temporary menopause and even osteoporosis (brittle bones) if taken over an extended period.

A hysterectomy eradicates all the fibroids by removing the entire uterus. This is a significant surgical procedure usually performed under general anaesthesia, requiring up to six weeks of recovery. Pregnancy is not possible after hysterectomy, and the time to menopause may be shortened.

Abdominal myomectomy
A major surgical procedure involving an incision through the skin on the lower abdomen, removing the fibroids from the wall of the uterus. The uterine muscle is then sewn back together using several layers of stitches.

Laproscopic myomectomy
A minimally invasive procedure when the surgeon accesses and removes fibroids through several small abdominal incisions

Uterine artery embolisation (UAE)
UAE is the injection of small particles to block the blood vessels around the uterus, causing the fibroids to die and shrink over time. While generally effective, UAE can be associated with significant pain and may also affect ovarian function, sometimes even causing earlier menopause. While pregnancy is possible after UAE, it is associated with an increased risk of complications such as preterm labour and delivery, postpartum haemorrhage and miscarriage.

Hysteroscopic myomectomy
A hysteroscopic myomectomy is a surgical treatment option that removes selected fibroids using a device inserted through the cervix into the uterine cavity. It can therefore only treat fibroids visible within the uterine cavity, and often requires additional treatments to fully remove some fibroids. It does preserve the uterus and fertility potential.

Transcervical fibroid ablation with the Sonata System
The Sonata System uses a device inserted into the uterine cavity through the cervix to locate, target and treat individual fibroids using radiofrequency energy. Because the device contains ultrasound for visualisation, Sonata is not limited to fibroids that are visible to the naked eye, unlike hysteroscopic myomectomy. As the fibroids are treated from inside the uterus, the Sonata System does not require any incisions. No tissue is cut or surgically removed, and the uterus is preserved.

Treat Smarter with Sonata
“Sonata offers the opportunity for non-invasive treatment for uterine fibroids that can be otherwise difficult or more risky to treat,” says consultant gynaecologist Mr Marwan Habiba, who offers the treatment at University Hospitals of Leicester NHS Trust. “Sonata enables accurate, precise localisation of the fibroid and is much more time-effective and less invasive than other treatment options such as an open or laparoscopic myomectomy. An important feature is that the endometrium is less likely to be affected by scar tissue, compared to more traditional resection, and the faster, post-operative recovery time means patients are usually able to go home on the day of surgery. With these advantages, Sonata should be an option for suitable women suffering from uterine fibroids.”

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The Sonata System is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding. For Indication and Safety Information, or to learn more about the Sonata System, visit Gynesonics, Sonata, and the logo are trademarks and registered trademarks of Gynesonics, Inc. All other trademarks are properties of their respective owners. Gynesonics products are covered by US and foreign patents. See ©2020 Gynesonics, Inc
[2] Millennium Research Group, Medtech Insights, and company estimates 
[3] 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.