INSIGHTEC Announces FDA Approval of Exablate Neuro for the Treatment of Tremor-Dominant Parkinson's Disease

无切口手术技术独角兽 INSIGHTEC : FDA 批准 Exablate Neuro 治疗震颤性帕金森

2018-12-19 16:27:09 PR Newswire


INSIGHTEC®, a global medical technology innovator of incisionless surgery, today announced that The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has approved an expansion of the indication of Exablate Neuro to include the treatment of patients with tremor-dominant Parkinson's disease (PD). The Exablate Neuro is a focused ultrasound device for performing incisionless thalamotomy guided by MR imaging. This expansion adds medication-refractory tremor from PD to the current Exablate Neuro indication for incisionless, focused ultrasound thalamotomy for medication-refractory essential tremor. "This is another validation of a great technology," said Jeff Elias, MD, of the University of Virginia School of Medicine. "Patients are attracted to the less invasive aspects of focused ultrasound. Now Parkinson's patients, for whom tremor is their primary disability, have more treatment options than conventional cranial surgery. While focused ultrasound is not curative for Parkinson's disease, it can provide significant quality of life benefits. Research continues for the other symptoms of Parkinson's," he concluded. Tremor, rigidity, slowness of movement and postural instability are the cardinal features of Parkinson's disease (PD). In an estimated 10 - 20% of PD patients, the primary symptom is tremor. These patients initially have tremor and as the disease progresses, they may experience an onset of relatively mild bradykinesia and rigidity. Upon further disease progression, tremor remains the symptom with the most severe impact on daily activities. "Focused ultrasound has the potential to improve the quality of life of patients living with medication-refractory tremor, whether from essential tremor or Parkinson's disease," said Maurice R. Ferré, MD, INSIGHTEC Chief Executive Officer and Chairman of the Board. "This is an important milestone in expanding focused ultrasound treatment for a growing number of neurological indications." During the focused ultrasound treatment, sound energy passes safely through a patient's skull with no surgical incisions to heat and precisely ablate the target in the thalamus. The treatment allows the neurosurgeon to create a personalized treatment plan and to evaluate feedback of the patient's symptom relief or potential side effects in real-time. Patients must be at least 30 years of age. This approval was based on data from a study led at the University of Virginia School of Medicine and was also conducted at Swedish Neuroscience Institute in Seattle. About INSIGHTEC INSIGHTEC is a global medical technology innovator transforming patient lives through incisionless brain surgery using MR-guided focused ultrasound. The company's award-winning Exablate Neuro™ is used by neurosurgeons to perform the Neuravive™ treatment to deliver immediate and durable tremor relief for essential tremor and tremor-dominant Parkinson's disease patients. 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, Florida, with offices in Dallas, Tokyo and Shanghai.
全球无切口手术医疗技术创新者INSIGHTEC®今天宣布,美国食品和药物管理局(FDA)的器械和放射健康中心(CDRH)已批准扩大Exablate Neuro的适应症,包括治疗患者伴有震颤占优势的帕金森病(PD)。 Exablate Neuro是一种聚焦超声设备,用于通过MR成像进行无切口丘脑切开术。这种扩张将PD的药物难治性震颤增加到目前的Exablate Neuro适应症,用于无切口,聚焦超声丘脑切开术治疗药物难治性特发性震颤。 “这是一项伟大技术的又一次验证,” 弗吉尼亚大学医学院的医学博士Jeff Elias说。“患者被聚焦超声检查的侵入性较小的方面所吸引。现在帕金森病患者,其震颤是他们的主要残疾,比传统的颅骨手术有更多的治疗选择。虽然聚焦超声不能治疗帕金森病,但它可以提供显着的质量生活受益。对帕金森症的其他症状的研究仍在继续,“他总结道。 震颤,僵硬,运动缓慢和姿势不稳定是帕金森病(PD)的主要特征。在估计10-20%的PD患者中,主要症状是震颤。这些患者最初患有震颤,随着疾病的进展,他们可能会出现相对轻微的运动迟缓和僵硬。在疾病进一步发展时,震颤仍然是对日常活动影响最严重的症状。 “聚焦超声波有可能改善患有药物难治性震颤的患者的生活质量,无论是来自特发性震颤还是帕金森病,”INSIGHTEC首席执行官兼董事会主席医学博士MauriceR.Ferré说。“这是扩大聚焦超声治疗以应对越来越多神经系统适应症的一个重要里程碑。” 在聚焦超声治疗期间,声能安全地通过患者的头骨,没有手术切口加热并精确消融丘脑中的目标。该治疗允许神经外科医生创建个性化治疗计划,并实时评估患者症状缓解或潜在副作用的反馈。患者必须至少30岁。 该批准是基于弗吉尼亚大学医学院领导的一项研究的数据,也是在西雅图的瑞典神经科学研究所进行的。 关于INSIGHTEC INSIGHTEC是一家全球医疗技术创新者,通过使用MR引导聚焦超声的无切口脑外科手术改变患者的生活。该公司屡获殊荣的Exablate Neuro™被神经外科医生用于执行Neuravive™治疗,为特发性震颤和震颤占优势的帕金森病患者提供即时和持久的震颤缓解。正在与领先的学术和医疗机构合作,开展对神经科学领域未来应用的研究。INSIGHTEC总部位于以色列海法和佛罗里达州迈阿密,在达拉斯,东京和上海设有办事处。