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ExAblate® 2000 Receives CE Mark Certification

by Joan Trombetti, Writer | June 18, 2007
InSightec's combination
MRI/Ultrasound machine
both images and treats

(click to enlarge)
Haifa, Israel -- InSightec Ltd has announced that the ExAblate® 2000 system, which combines Magnetic Resonance imaging and Focused Ultrasound to non-invasively treat tumors inside the body without incisions, has received European CE Mark for treatment of pain caused by bone metastases.

After the lungs and liver, bones are the most common organ that sees metastases from cancer cells. In metastatic prostate cancer, most patients also have skeletal metastases, and the same applies for breast cancer patients, where bone is the second most common site of metastatic spread (90%). Approximately 452,000 people in the United States suffer from cancer with metastases to the bone, and in Europe, 100,000 are diagnosed with bone metastases every year. Controlling and managing the pain is critical in treating these patients.

As part of a clinical study that supports CE mark certification, a pain questionnaire using VAS (Visual Analog Scores) was sent to patients to monitor changes in pain levels and determine the value of pain management. Most patients reported immediate improvement, and many said that they stopped all pain medication completely.

"Clinical studies have shown that MRgFUS treatment non-invasively alleviates the pain caused from cancer that has spread to the bones," said David Gianfelice, M.D. Chief of Vascular/Interventional Radiology, Mount Sinai Hospital and University Health Network (UHN) Joint Department of Medical Imaging in Toronto, Ontario, Canada. "The treatment also has the potential to lower patients' reliance on analgesics and provide them with the opportunity for improved quality of
life."

"ExAblate® 2000 has been used to successfully to 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."