New minimally invasive treatment for fibroids launches

Gynesonics, a medtech 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 integrates ultrasound and radiofrequency into a single, handheld delivery system to locate and target individual fibroids. Gynesonics claims it is a 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 US and a recent survey revealed that women with uterine fibroids, on average, delay seeking treatment for 3.6 years, with 79% wanting to avoid invasive surgery that can require lengthy recoveries. 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.

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.

Professor Justin Clark, president of the British Society for Gynaecological Endoscopy, said: “Uterine fibroids affect one in three 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. Increasingly effective medical and minimally invasive treatments would be widely welcomed by women and their healthcare professionals.”

The CE-marked Sonata System offers a treatment as a day case procedure and is associated with procedural safety and durable clinical outcomes. 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.

Dr David Toub, medical director of Gynesonics, FACOG, said: “We’re encouraging healthcare professionals to #TreatSmarterWithSonata, in order to improve clinical outcomes for their patients and deliver significant cost efficiencies for healthcare organisations.”

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 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% of patients needing no surgical reintervention within 12 months of treatment with Sonata. About 90% of patients reported a reduction in menstrual bleeding within three months of having a Sonata treatment, and 95% within 12 months.