InSightec receives EU approval for treating bone cancer pain with
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.
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."