Insightec’s Exablate Neuro, a groundbreaking medical device, has recently received its second CE mark for the treatment of essential tremor. This achievement marks a significant milestone in the field of neurology and offers hope to millions of people suffering from this debilitating condition.
Essential tremor is a neurological disorder characterized by involuntary shaking or trembling of certain parts of the body, most commonly the hands. It can significantly impact a person’s quality of life, making simple tasks such as eating, writing, or even holding a cup of coffee challenging. While medications can help manage the symptoms to some extent, they often come with side effects and may not provide long-term relief.
The Exablate Neuro, developed by Insightec, is a non-invasive treatment option that utilizes focused ultrasound technology to target and destroy specific areas in the brain responsible for causing essential tremor. The device combines magnetic resonance imaging (MRI) guidance with high-intensity focused ultrasound (HIFU) to precisely deliver therapeutic ultrasound waves to the targeted area, without the need for incisions or radiation.
The first CE mark for Exablate Neuro was obtained in 2016, allowing it to be used for the treatment of medication-refractory essential tremor in patients who are not eligible for surgical interventions such as deep brain stimulation (DBS). This initial approval revolutionized the treatment landscape for essential tremor patients, offering a non-invasive alternative to traditional surgical procedures.
The recent second CE mark expands the indications for Exablate Neuro, allowing it to be used in patients who have not responded well to medication and are considering surgical interventions. This means that more individuals suffering from essential tremor can now benefit from this innovative technology, even if they were previously deemed ineligible for surgical options.
The treatment process with Exablate Neuro involves several steps. First, the patient undergoes an MRI scan to identify the precise location of the tremor-causing area in the brain. This information is then used to plan the treatment, ensuring accurate targeting of the affected region. During the procedure, the patient lies inside an MRI machine while the Exablate Neuro delivers focused ultrasound waves to the targeted area, heating and destroying the problematic tissue. Real-time MRI monitoring allows the medical team to monitor and adjust the treatment as needed.
One of the key advantages of Exablate Neuro is its non-invasive nature. Unlike traditional surgical interventions, there are no incisions, no anesthesia, and no risk of infection. Patients can typically go home on the same day and resume their normal activities within a few days. The treatment is also customizable, allowing physicians to tailor the therapy to each patient’s specific needs.
Clinical studies have demonstrated the effectiveness of Exablate Neuro in reducing essential tremor symptoms. In a multicenter trial involving 76 patients, 56% experienced a significant improvement in their tremor score three months after treatment, with 49% maintaining this improvement at 12 months. The results also showed a reduction in disability and improved quality of life for the treated patients.
The second CE mark for Exablate Neuro is a significant achievement for Insightec and a major breakthrough in the treatment of essential tremor. It offers new hope to patients who have exhausted other treatment options and were previously left with limited choices. With its non-invasive approach and proven efficacy, Exablate Neuro has the potential to transform the lives of millions of people worldwide suffering from essential tremor.
- SEO Powered Content & PR Distribution. Get Amplified Today.
- PlatoData.Network Vertical Generative Ai. Empower Yourself. Access Here.
- PlatoAiStream. Web3 Intelligence. Knowledge Amplified. Access Here.
- PlatoESG. Automotive / EVs, Carbon, CleanTech, Energy, Environment, Solar, Waste Management. Access Here.
- PlatoHealth. Biotech and Clinical Trials Intelligence. Access Here.
- ChartPrime. Elevate your Trading Game with ChartPrime. Access Here.
- BlockOffsets. Modernizing Environmental Offset Ownership. Access Here.
- Source: Plato Data Intelligence.
- Source Link: https://platohealth.ai/insightecs-exablate-neuro-secures-second-ce-mark-for-essential-tremor-treatment/
An Overview of the FDA’s Draft Guidance on Translation of GLP Study Reports in the United States
An Overview of the FDA’s Draft Guidance on Translation of GLP Study Reports in the United States The Food and...