InSightec receives European CE mark for ExAblate 2000

InSightec announced today that its ExAblate 2000 system has received the CE mark certification for pain palliation of bone metastases. In clinical studies, which supported the CE mark certification, patients reported their pain levels using VAS (Visual Analog Score). The majority of patients reported an immediate improvement in pain scores. Many also reported that they stopped using any analgesic pain relief.

According to the company, the ExAblate 2000 is the first system to use the breakthrough MRgFUS technology that combines MRI and high intensity focused ultrasound to thermally ablate uterine fibroid tissue. MR thermal feedback, provided uniquely by the system, allows the physician to control and adjust the treatment in real time to ensure that the targeted tumour is fully treated and surrounding tissue is spared.

"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."