EXABLATE® RECEIVES EUROPEAN CE MARK FOR TREATMENT OF ADENOMYOSIS
TIRAT CARMEL, Israel (June 23, 2010) -- INSIGHTEC Ltd. announced today that its 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.
Adenomyosis is a benign gynecologic growth characterised by the presence of ectopic endometrial glands and stroma in the myometrium and hyperplasia (excessive cell reproduction) of adjacent smooth muscles. It manifests with uterine myoma-mimicking symptoms such as heavy menstrual bleeding, pain, and diffuse uterine enlargement. Women with this condition are unlikely to conceive.
“Patients who suffer from Adenomyosis and want to preserve their uterus have had few viable options in the past,” said Dr. Jaron Rabinovici, Vice-Chair, Department of Obstetrics and Gynecology, Sheba Medical Center. “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.
The availability of this procedure is a welcome development for women living with this condition, because it means they now 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.”
“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 ” said Dr. Kobi Vortman, President and CEO of INSIGHTEC. “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.”
While fibroids and adenomyosis are both non-cancerous tumours of the uterus, fibroids grow out from the uterine wall, and adenomyosis originates from swelling of the uterine wall as a result of the penetration of endometrial tissue. While a fibroid is distinct from the uterine wall and can be removed, adenomyoma cannot be removed without actually removing the involved uterine muscle. Clear-cut surgical excision of the whole adenomyosis lesion is difficult because of its ambiguous boundary.
INSIGHTEC is the global leader in MRgFUS. The Company, founded in 1999, develops and distributes a non-invasive therapy platform that is transforming medicine. INSIGHTEC is continuously expanding its applications ranging from functional neurosurgery to oncology and gynecology. MRgFUS is embraced by world-renowned physicians in more than 120 medical facilities who applaud both its clinical and economic value. The Company has received numerous innovation awards, among others from the Wall Street Journal and TIME magazine. INSIGHTEC is privately held by GE Healthcare, Elbit Imaging, York Capital Management, GEOC Hengtong Investment Limited Partnership and MediTech Advisors.