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.
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.
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。