InSighte's ExAblate system has received an expanded CE mark certification for 'ablation of soft tissue for treatment of benign tumors, including uterine fibroids and adenomyosis' using Magnetic Resonance guided Focused Ultrasound (MRgFUS) technology.
The certification was granted on the basis of clinical evidence showing that focused ultrasound is safe and effective in treating symptomatic adenomyosis, which included published data of patients with the condition.
The certification body KEMA Quality agreed that treatment with InSightec’s system resulted in statistically significant improvement in subjective symptoms, and significant volume reduction of the treated mass.
The availability of the procedure is a welcome development for women living with this condition, because it means they have a treatment choice that is non-invasive, safe and effective. More importantly, women who underwent this non-invasive option for adenomyosis conceived and delivered subsequently healthy children.”
Jaron Rabinovici, vice-chair, department of Obstetrics and Gynecology, Sheba Medical Center, said: “Patients who suffer from Adenomyosis and want to preserve their uterus have had few viable options in the past. Adenomyosis may have a grave impact on a woman’s health and quality of life and until recently hysterectomy was the only accepted treatment involving adverse effects and hospitalization. Another treatment option is medication, which offered only temporary relief of symptoms and had its own set of side effects.”
Kobi Vortman, president and CEO of InSightec, said: “ExAblate has been used to treat uterine fibroids non-invasively with great success since 2004, and this expanded CE Mark represents a significant milestone in our commitment to continually broaden the applications of this non-invasive, innovative therapy in addressing women’s health.
“This procedure is done on an outpatient basis, patients can return to work the next day, and complications are rare. The clinical and economic advantages of ExAblate allow for enhanced access to treatment and improved quality of life – for more women.”