TIRAT CARMEL, Israel, December 2 /PRNewswire/ -- InSightec Ltd. announced today that new publications show that Magnetic Resonance-guided Focused Ultrasound (MRgFUS) with the ExAblate(R) system has the potential to be an effective noninvasive pain-relieving treatment for tumors that have spread to the bones (bone metastases). The results of a 31 patient study appear in the November 11 online issue of Annals of Surgical Oncology, while data from an eleven-patient subgroup analysis of that study were published separately in the October issue of Radiology.
"The increasing longevity of the population along with the rise in cancer incidence during the last decade and ever-improving treatment outcomes for primary cancers contributes to the growing number of patients living with metastatic bone disease," said Boaz Liberman, MD, Head of Orthopedic Oncology, of Sheba Medical Center, Tel Hashomer, Israel and lead author of the 31-patient analysis. "Increasing focus on cancer patients' quality of life has led to a search for effective pain-relieving treatments with fewer short- and long-term side effects. These preliminary results suggest that the ExAblate(R) treatment using MRgFUS has the potential to provide a safe and effective noninvasive treatment for patients suffering from painful bone metastases."
Of the 25 patients included in Dr. Liberman's efficacy analysis, 72% (18/25) experienced significant pain relief, with 36% (9/25) reporting no pain at three months. More than half of the patients (52%) reported substantial pain relief at the follow-up visit three days after their treatment. A majority of the patients also decreased their opioid and non-opioid analgesic intake following treatment. No device-related adverse events were reported.
In subgroup analysis, researchers from Mount Sinai Hospital in Toronto who participated in this study concluded that ExAblate(R) may be an effective and safe treatment option in reducing the pain caused by bone metastases. They treated 12 lesions in 11 patients who ranged in age from 38 to 84. After undergoing treatment, some patients experienced pain relief in as little as three days, with all experiencing relief within 14 days. By the end of the three month follow-up period all patients were virtually pain-free; four patients reported being able to resume more vigorous activities such as housework, light exercise and other outdoor activities. No adverse side effects were recorded immediately after treatment or during follow-up.
InSightec is currently enrolling patients into a FDA approved Phase 3
pivotal study to confirm these earlier results. InSightec expects to enroll
148 subjects with bone metastases who are not candidates to radiation
treatments into the study at centers throughout the U.S. and around the
world. Participating sites include Brigham & Women's Hospital in Boston, Fox
Chase Cancer Center in Philadelphia, Houston Methodist in Houston, Texas,
SightLine Medical Center, Houston, Texas, the Lahey Clinic in Burlington,
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InSightec is also conducting a similar study outside the United States, in Europe, Asia, and Americas.
Bone pain is the most common source of pain in patients suffering from metastatic cancer. Almost all patients with metastatic prostate cancer have skeletal metastases and 90% of patients with progressive breast cancer develop these painful and debilitating lesions. Current pain treatments consist of systemic therapy (analgesics, chemotherapy, hormonal therapy and bisphosphonates) and local treatments (radiation, surgery and more recently, Radio Frequency Ablation (RFA)).
During the ExAblate(R) treatment, the physician uses the Magnetic Resonance Imaging (MRI) with registered CT images to visualize the patient's anatomy and then aims focused ultrasound waves at the tumor to relieve the pain. 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 that will relieve the pain while minimizing damage to adjacent tissue.
The ExAblate(R) system will be on display at the GE Healthcare booth (number #5529 South Hall) at the Radiological Society of North America's (RSNA) 94th Scientific Assembly and Annual Meeting taking place in Chicago from November 30 to December 5 at the McCormick Place Convention Center.
ExAblate(R) is currently used commercially as a treatment for symptomatic uterine fibroids. The system received its European CE Mark in uterine fibroids in 2002 and the U.S. Food and Drug Administration approved the system as a treatment for symptomatic uterine fibroids in 2004. Over 4,500 symptomatic women have been treated with the ExAblate to date with 92% reporting symptom relief up to 36-months after treatment. The ExAblate system received the European CE Mark certification for pain palliation of bone metastases in June 2007.
InSightec Ltd. is a privately held company owned by Elbit Imaging, General Electric, MediTech Advisors, LLC and employees. It was founded in 1999 to develop the breakthrough MR guided Focused Ultrasound technology and transform it into the next generation operating room. Headquartered near Haifa, Israel, the company has over 150 employees and has invested more than $150 million in research, development, and clinical investigations. Its U.S. headquarters are located in Dallas, Texas. For more information, please go to: http://www.insightec.com/
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|SOURCE InSightec Ltd|
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