NATIONAL REIMBURSEMENT INSIGHTEC receives national reimbursement from the Japanese Ministry of Health, Labour and Welfare (MHLW) for treating Parkinson's Disease.
HAIFA, Israel and MIAMI, Sept. 1, 2020 -- INSIGHTEC®, a global medical technology innovator of incisionless surgery, today announced that it has received national reimbursement from the Japanese Ministry of Health, Labour and Welfare (MHLW) for treating Parkinson's Disease.
Parkinson's Disease is a progressive neurodegenerative disorder with an incidence in Japan of 1 in 100 people above the age of 60, based on a survey conducted by MHLW. INSIGHTEC's Exablate® Neuro uses focused ultrasound waves to precisely target and ablate tissue deep within the brain with no incisions. The treatment is performed under Magnetic Resonance Imaging (MRI) guidance for real-time treatment monitoring.
"Parkinson's Disease patients now have a new incisionless surgical treatment option, focused ultrasound," commented Professor Takaomi Taira, Director of Stereotactic and Functional Neurosurgery, Department of Neurosurgery, Tokyo Women's Medical University (TWMU), Tokyo, Japan. "Using focused ultrasound we can precisely target and treat the brain regions which contribute to improvements of the patient's symptoms."
Exablate Neuro is approved for targeting the thalamus for treating Tremor-dominant Parkinson's Disease, and the globus pallidum for treating advanced Parkinson's Disease in patients suffering from mobility, rigidity, or dyskinesia symptoms.
"Japan is the first country in the world to cover focused ultrasound for Parkinson's Disease with nationwide public health insurance," commented Maurice R. Ferré MD, INSIGHTEC CEO and Chairman of the Board of Directors. "This is a major milestone for patients with Parkinson's Disease across Japan."
The Exablate Neuro device received MHLW approval for the treatment of medication-refractory essential tremor and National Health Insurance coverage in June 2019 and received a pre-market approval (PMA) for the treatment of Parkinson's Disease in January 2020. There are currently 12 medical institutions in Japan performing the MR-guided focused ultrasound treatment for essential tremor on a routine basis.
"This extended coverage by the National Health Insurance provides an incisionless treatment option for Parkinson's Disease patients," said Yair Bauer, Country Manager, INSIGHTEC Japan. "This adds to the existing coverage for treatment of tremor from essential tremor and Parkinson's Disease," he added
About INSIGHTEC Japan K.K. INSIGHTEC Japan K.K. is a subsidiary of INSIGHTEC LTD. The company is the regulatory market approval holder of Exablate Neuro (Exablate 4000) and its distributor in Japan. Founded in 2005, its mission is to provide focused ultrasound treatments for neurosurgery and women's health indications, in order to significantly improve the quality of life for patients in Japan. For more information please visit: www.insightec.com/JP
About INSIGHTEC INSIGHTEC is a global medical technology innovator transforming patient lives through incisionless brain surgery with MR-guided focused ultrasound. Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions. INSIGHTEC is headquartered in Haifa, Israel, and Miami, with offices in Dallas, Shanghai and Tokyo.
For more information, please visit: www.insightec.com
19-Nov-2020 INSIGHTEC® incisionless MRgFUS surgery to be funded by NHS England to treat Essential Tremor condition that causes shaking of the hands, head and voice, but it can also cause legs and trunk to shake. The tremor begins mildly and progresses over time to become more severe, and in some patients, severe enough to interfere with daily activities, such as eating and writing.
“This is extremely exciting news for those living with Essential Tremor,” said Prof Wady Gedroyc, MD, Consultant Radiologist at London’s St. Mary’s Hospital. “Essential Tremor can be incredibly debilitating and impacts virtually every aspect of a person’s life. There’s a significant unmet need in terms of treatment options so I am delighted that NHS England has recognised the value that this new technology can bring to patients. I am looking forward to seeing the first NHS patients from April next year.”
MRgFUS is an incisionless treatment option for Essential Tremor, often performed in an outpatient setting, enabling patients to return home the same day. High intensity ultrasound waves, guided by MRI, converge at a small target to create a permanent lesion in the specific area of the brain responsible for the tremor.
“Medicines only work in approximately 50% of people with Essential Tremor, and so to have another treatment option available that is incisionless is a major breakthrough for this patient group,” commented Prof Dipankar Nandi, MD, Consultant Neurosurgeon, Imperial College Healthcare NHS Trust. “Now that the NHS has agreed to make focused ultrasound available from next April, it is critical that we ensure equity of access across the country, and not just for those that can make it to London.”
“NHS funding is an important step in expanding patient access to Focused Ultrasound,” said Maurice R. Ferré MD, INSIGHTEC CEO and Chairman of the Board of Directors. "Most importantly, people living with tremor can now get back their independence and their lives.”
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