InSightec Begins Study of ExAblate to Treat Pain Caused by Bone Metastases

December 19, 2007 - InSightec Ltd. announced that the FDA has approved an investigational device exemptions (IDE) application that allows the company to launch a Phase 3 pivotal study to determine if its ExAblate incisionless surgery system can safely and effectively reduce the pain associated with bone metastases in patients who have failed to respond to radiation therapy.
The noninvasive, ionized radiation-free magnetic resonance-guided focused ultrasound (MRgFUS) system was approved to treat women suffering from symptomatic uterine fibroids in 2004. Over 3,500 women have already undergone treatment with ExAblate worldwide.
Current treatment options for pain control consist of systemic therapy (analgesics, chemotherapy, hormonal therapy and bisphosphonates) and local treatments (radiation, surgery and more recently, Radio Frequency Ablation (RFA)).
Using the ExAblate system, the physician uses MRI to visualize the patient's anatomy and then aims focused ultrasound waves at the tumor to thermally ablate, or destroy it. The MRI allows the physician to monitor and continuously adjust the treatment in real time. The patient is consciously sedated to alleviate pain and minimize motion. Due to the high acoustic absorption and low thermal conductivity of the bone cortex, it is possible to use a low level of energy and still achieve a localized heating effect while minimizing damage to adjacent tissue.
InSightec expects to enroll 148 subjects with bone metastases who did not respond to radiation treatments into the study, which is expected to take place at 15 centers throughout the U.S. and internationally.
For more information: www.insightec.com