The published results of a 31-patient study and data from an eleven-patient subgroup analysis of that study showed that: 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, results concluded that ExAblate® may be an effective and safe treatment option in reducing the pain caused by bone metastases. Treatment on 12 lesions in 11 patients who ranged in age from 38 to 84 was done. 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.
For more information on the clinical study, see http://www.mycancerpain.org/.
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