CE Mark certification expanded to include adenomyosis

Until late last month, women suffering from adenomyosis – a benign gynecologic condition that causes heavy menstrual bleeding, pain and diffuse uterine enlargement – had two treatment options: have a hysterectomy and lose the ability to conceive; or, take medication for temporary symptom relief.

But on June 23, women in the European Union were offered a welcome new alternative that is safe, effective and non-invasive. EU authrorities expanded the approved uses of MR-guided focused ultrasound – amending the CE mark certification for InSightec's ExAblate 2000 system to include "ablation of soft tissue for treatment of benign tumors, including uterine fibroids and adenomyosis."

The ExAblate's original CE Mark, received in 2002 approved focused ultrasound treatments for women with uterine fibroids who had completed their families. Certification language was modified in 2007, noting that women planning future pregnancies should consult with their physicians before seeking treatment with the system.

The new certification permitting more widespread use was granted, according to InSightec, on the basis of published data and other clinical evidence showing that focused ultrasound is safe and effective in treating symptomatic adenomyosis.

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.

Fibroids and adenomyosis are non-cancerous tumors of the uterus. Because fibroids grow out from the uterine wall and have distinct boundaries, they can be removed without affecting nearby tissue. By comparison, adenomyosis originates from swelling of the uterine wall caused by penetration of endometrial tissue. Its boundaries are ambiguous. This makes it impossible to surgically excise the whole adenomyosis lesion without removing uterine muscle.

The newly-approved focused ultrasound treatment for adenomyosis will be available at all ExAblate sites in Israel, France, Germany, Italy, Russia, Spain and the United Kingdom, according to Ron Szekely, InSightec's Director of Women's Health Programs.

Szekely added that treatment will also be offered in Brazil, Taiwan, Australia, Mexico, Singapore and Hong Kong. Szekely said that InSightec is now preparing a regulatory plan for other countries.

Written by Ellen C., McKenna

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