InSightec receives EU approval for treating bone cancer pain with focused ultrasound

13 June 2007

Haifa, Israel. The ExAblate 2000 system, produced by InSightec Ltd., has received the European CE Mark certification for pain palliation of bone metastases.

InSightec reports that in clinical studies that supported the CE mark certification patients reported their pain levels using VAS (visual analog score), a pain questionnaire used to monitor changes in pain levels and assess the efficacy of pain management. The majority of patients reported an immediate improvement in pain scores. Many also reported that they stopped using any analgesic pain relief.

Bone is the third most common organ to which cancer metastasizes, after the lungs and liver. Almost all patients with metastatic prostate cancer have skeletal metastases and in breast cancer, bone is the second most common site of metastatic spread, affecting 90% of patients with progressive breast cancer.

It is estimated 100,000 in Europe are diagnosed with bone metastases every year. Most cancer patients suffer from pain; controlling it and managing its symptoms are important treatment goals.

"ExAblate 2000 has been used to successfully treat uterine fibroids non-invasively with magnetic resonance guided focused ultrasound (MRgFUS) and this second CE Mark represents a significant milestone in our quest to expand the potential applications of this non-invasive, innovative therapy for oncology applications providing improved care for patients around the world," said Dr. Kobi Vortman, President and CEO of InSightec.

"This procedure can alleviate the patient's pain, has the potential to lower reliance on analgesics and provide patients with the opportunity for improved quality of life."

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