By AMANDA PEDERSEN
Medical Device Daily Senior Staff Writer
InSightec (Tirat Carmel, Israel) reported that the FDA has approved its Exablate MRI-guided focused ultrasound as a therapy to treat pain from bone metastases in patients who do not respond or cannot undergo radiation treatment for their pain.
This is the second FDA approval for Exablate, which has been widely used since it was approved in 2004 as a non-invasive outpatient therapy for uterine fibroids. Bone metastases occur when cancer cells break away from their primary site and spread to other parts of the body.
"This is our first application oncology and as such this is an entry point to oncology from many different view points . . . in many ways we are looking for unmet needs when we are entering this part of the market," Kobi Vortman, PhD, president/CEO of InSightec, told Medical Device Daily during a phone interview Monday from Israel. He said that the available data shows that about one-third of the patients suffering from bone metastases pain do not respond to radiation treatment. For that segment of the population, the only treatment option for this crippling bone pain is to drug them out with narcotics, Vortman said.
These patients are typically at the end of their life and want to spend the time they have left with family and trying to maintain at least some quality of life, he noted. "Once you start using narcotics you lose your quality of life, so from this point of view we are addressing an unmet need with a very effective treatment," Vortman said.
The second FDA approval for Exablate was based on the results of an international, multi-center, randomized clinical study comparing patients with painful bone metastases undergoing palliative therapy with the Exablate system to a similar group undergoing a placebo therapy. Patients who underwent the Exablate therapy reported clinically significant pain relief and improvement of quality of life during follow-up three months after treatment. More than 15 centers participated in the clinical trial.
Vortman said this FDA approval represents a significant milestone for InSightec in its quest to expand the applications for the Exablate therapy and to bring the MRI-guided focused ultrasound system into broad clinical use and improve patients' quality of life.
According to the company, the 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. Twenty hospitals in Europe and Asia-Pacific offer Exablate as a palliative therapy for bone metastases, InSightec noted.
"Pain is the most common and severe symptom of bone metastases, often causing significant physical and emotional discomfort with a large impact on enjoyment of life," said Mark Hurwitz, MD, principal investigator of the international, multi-center, randomized study that formed the basis of InSightec's pre-market application (PMA) approval with the FDA. "Pain palliation by Exablate can dramatically improve the quality of life for cancer patients with bone metastases. Results from the clinical study showed that Exablate therapy significantly reduces pain caused by bone metastases. Patients also reported lasting improvement in well-being and function, along with a decrease in the need for medication."
Hurwitz, who is currently director of thermal oncology and vice chair of the radiation oncology department at Thomas Jefferson University (Philadelphia), led the study during his previous tenure as director of regional program development for the department of radiation oncology at Brigham and Women's Hospital (Boston) and associate professor of radiation oncology at Harvard Medical School (Boston).
InSightec says it will be conducting a multi-center post-marketing study of 75 U.S. patients who suffer from painful bone metastases and will also be establishing a commercial registry to collect data about patients undergoing Exablate therapy for the palliation of painful bone metastases.
ExAblate combines therapeutic acoustic ultrasound waves and continuous guidance and treatment monitoring with an MRI. 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, resulting in rapid reduction in pain.
Vortman told MDD that treating this same pain with radiation therapy takes weeks, but with the Exablate system patients experience a "significant drop in pain" in just two to three days.
According to the American Cancer Society (Atlanta), more than two-thirds of breast and prostate cancers that metastasize spread to the bones and this also occurs in up to 30% of metastatic lung, bladder and thyroid cancers. Up to 30% of patients with bone metastases either do not respond to radiation therapy or will be unable to undergo radiation for pain relief, the company noted.
Amanda Pedersen, 912-660-2282;
Published October 23, 2012