December 19, 2012 — At RSNA 2012, InSightec Ltd. announced U.S. Food and Drug Administration (FDA) approval for the ExAblate magnetic resonance imaging (MRI) guided focused ultrasound for treatment of painful bone metastases in patients who are not candidates for or refuse to undergo radiation treatment.
This is the second FDA approval for ExAblate, which received FDA approval in 2004 as a non-invasive, outpatient therapy for uterine fibroids. GE Healthcare is a minority shareholder of Insightec Ltd and is a distributor of ExAblate in many countries around the world. The system was showcased by InSightec at the GE Healthcare booth at RSNA 2012.
InSightec’s ExAblate system is exclusively compatible with GE Healthcare’s normal and wide bore systems, including Signa HDxt 1.5T, Signa HDxt 3.0T, Optima MR450 & 450w, and Discovery MR750 & 750w. It combines therapeutic acoustic ultrasound waves with continuous guidance and treatment monitoring by MRI. This combination of technologies is called Magnetic Resonance guided Focused Ultrasound Therapy (MRgFUS). Physicians use the MRI to plan and guide the therapy and monitor treatment outcome. The focused ultrasound acoustic energy destroys the nerves causing the pain from bone metastases, resulting in rapid reduction in pain.
“The FDA approval of ExAblate is an exciting next step in GE’s investment in InSightec,” said Tom Gentile, president and CEO of GE Healthcare Systems and InSightec board member. “Pain is the most common and most severe symptom for patients suffering from bone cancer; we believe that ExAblate can help significantly improve the quality of life for patients. This is the first approved oncology application of ExAblate and we are excited that InSightec will continue researching in this area to expand the applications of this product.”
Bone metastases occur when cancer cells break away from their primary site and spread to other parts of the body. According to the American Cancer Society, more than two-thirds of breast and prostate cancers that metastasize spread to the bones. This also occurs in up to 30 percent of metastatic lung, bladder, and thyroid cancers.
Pain is the most common and severe symptom of bone metastases and is usually treated with radiation therapy. However, up to 30 percent of patients either do not respond to radiation therapy or are unable to undergo radiation for pain relief. Results from the clinical study to support the PMA approval showed that ExAblate therapy offers these patients significantly reduced pain and also improves patient well-being and function. Patients also reported reduced use of medications.
“The new FDA approval of ExAblate for pain palliation offers new options for cancer patients with crippling bone pain who are seeking pain-management options but are no longer eligible for radiation treatment,” said Kobi Vortman, president of InSightec. “This second approval represents a significant milestone in our quest to provide non-invasive treatment alternatives to improve patients’ quality of life and establish ExAblate MRI-guided focused ultrasound for new clinical uses.”
ExAblate is the only FDA-approved MRI-guided focused ultrasound system for treating uterine fibroids and bone metastases related pain management. It has also received European CE marking for uterine fibroids, bone metastases, and adenomyosis. ExAblate is a GE healthymagination-validated product and will be co-marketed by GE Healthcare as InSightec’s distributor.
For more information: www.insightec.com