InSightec Receives FDA Approval for Bone Pain Ultrasound Therapy
Non-ionizing alternative to radiation therapy for patients with painful bone metastases
CHICAGO — — Today at RSNA 2012, InSightec Ltd. is proud to announce US Food and Drug Administration (FDA) approval for the ExAblate 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 (NYSE:GE) is a minority shareholder of Insightec Ltd and is a distributor of ExAblate in many countries around the world. The system will be 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 unique 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% 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 Dr. 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.
GE Healthcare at RSNA 2012
Each year in Chicago, the conference of the Radiological Association of North America (RSNA) provides a forum for showcasing the latest innovations in medical imaging. If you are attending the conference, please visit GE Healthcare at booth number 3335 in McCormick Place south hall. Throughout the week of the event, GE Healthcare will distribute news and information using these digital platforms:
· Digital press kit: http://newsroom.gehealthcare.com/press-kits/ge-healthcare-at-rsna-2011/
· Twitter: Follow @GEHealthcare and our hashtag #GERSNA
· YouTube channel: http://www.youtube.com/gehealthcare
InSightec at RSNA 2012
Twelve talks will be given on ExAblate clinical results in addition to several poster sessions.
Details about the ExAblate talks to be presented at RSNA can be found here:
ABOUT GE HEALTHCARE
GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the world at a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems.
Our “healthymagination” vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing costs, increasing access and improving quality around the world. Headquartered in the United Kingdom, GE Healthcare is a unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employees are committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com.
InSightec Ltd. shareholders include Elbit Imaging, General Electric, and MediTech Advisors. Founded in 1999 InSightec developed ExAblate to transform MRI-guided Focused Ultrasound (MRgFUS) into a clinically viable technology. ExAblate has won several awards for innovation and its potential to help mankind including The Wall Street Journal Technology Innovation Awards and the European Union’s IST grand prize. TIME magazine recently named Focused Ultrasound as “one of 50 best inventions.” For more information about treatment centers and bone metastases please visit: http://www.InSightec.com and www.mycancerpain.org
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