TIRAT CARMEL, Israel, July 14 --
- Ten-Patient Feasibility Study Shows Safety and Potential for Non-Invasive
Deep Brain Ablation
InSightec Ltd. today announced that a team at the University Children’s
Hospital Zurich has completed a feasibility study testing the use of
non-invasive transcranial MR-guided focused ultrasound surgery (MRgFUS) for the
treatment of neuropathic pain. Ten adult patients diagnosed with chronic
neuropathic pain successfully underwent non-invasive deep brain ablation surgery
(central lateral thalamotomy) with transcranial MRgFUS and showed improvement in
pain scores and reduction of pain medication with no adverse effects at three
months follow-up. This is the first study in the world to test non-invasive
transcranial focused ultrasound as a treatment modality for functional brain
This study showed that we can perform successful operations in the depth of the
brain without opening the cranium or physically penetrating the brain with
medical tools, something that appeared to be unimaginable only a few years ago,
said Daniel Jeanmonod, neurosurgeon at the University of Zurich. By eliminating
any physical penetration into the brain, we hope to duplicate the therapeutic
effects of invasive deep brain ablation without the side effects for a wider
group of patients.
Neurosurgeons currently treat patients with functional neurological disorders
such as neuropathic pain or Parkinson’s disease by inserting a tiny probe
through the cranium and brain to reach and ablate damaged tissue.
The more traditional invasive treatment works to alleviate pain and other
symptoms, however it exposes the patient to complications, including infections,
bleeding and damage to surrounding brain tissue, Dr. Jeanmonod explained. Also,
only patients whose target tissue lies in the clear path of the probe are
eligible for the invasive procedure, he said.
We now have early clinical evidence suggesting that transcranial MRgFUS
provides a safe and effective way to non-invasively ablate tissue deep within
the brain, said Ernst Martin, M.D., Director of the Magnetic Resonance Center at
the University Children’s Hospital Zurich. While we need to monitor these
patients further, we are very encouraged by the results to date and look forward
to continuing our research. A non-invasive treatment that reduces the risk of
infection and bleeding will fill an unmet need for many patients who currently
have run out of treatment options or are unwilling to undergo invasive brain
surgery because of the risks associated with it.
One patient in the study suffered nerve damage from a spinal tumour that led to
severe pain and cramps in his right arm. The pain persisted for years and the
patient ultimately reported depression and suicidal thoughts because of his
condition. Immediately after receiving transcranial MRgFUS treatment on his
brain, he reported that the pain had disappeared. A short time later he was able
to resume normal activities that his neuropathic pain had prevented him from
doing, such as gardening and outings in the country with his family.
The Swiss research team is planning a larger study for functional brain
disorders and expands its clinical research to movement disorders, such as
Parkinson’s disease and tremor, and to other functional neurological
disorders later this year. Additional sites in North America are also expected
to initiate clinical research programs in functional brain disorders with
transcranial MRgFUS later this year.
About ExAblate(R) 4000
ExAblate is the first system to use the MR guided focused ultrasound technology
that combines MRI - to visualize the body anatomy, plan the treatment and
monitor treatment outcome in real time - and high intensity focused ultrasound
to target brain tissue non-invasively. MR thermometry allows the physician to
control and adjust the treatment in real time to ensure that the targeted area
is fully treated and surrounding tissue is spared. The ExAblate 4000 is a
platform for a variety of transcranial indications, such as brain tumours,
functional neurosurgery, stroke and targeted drug delivery.
The ExAblate(R) 2000, based on the same technology, was approved by the U.S.
Food and Drug Administration in 2004 as a treatment for symptomatic uterine
fibroids. 5,000 women have been treated worldwide to date. ExAblate 2000
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 160 employees and has invested more than US$150 million in
research, development, and clinical investigations. Its U.S. headquarters are
located in Dallas, Texas. For more information, please Go to:
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Media contact: Hollister Hovey Lazar Partners +1-646-871-8482
SOURCE: InSightec Ltd
Media contact: Hollister Hovey, Lazar Partners, +1-646-871-8482,