In an estimated 26% of Parkinson’s disease (PD) patients2, the primary symptom is tremor. These patients initially have tremor and as the disease progresses, they may experience onset of other symptoms. However, tremor remains the symptom with the most severe impact on their daily activities.
MR-guided focused ultrasound (MRgFUS) provides an incisionless treatment option for tremor-dominant Parkinson’s patients who do not respond to medications. Candidates for treatment must be Parkinsonian tremor patients 30 years or older.
During treatment, ultrasound waves heat and ablate the deep brain target with no surgical incisions. Treatment is guided by MR imaging for patient-specific planning, real-time temperature monitoring as well as immediate assessment of treatment outcome.
The result for many patients is immediate improvement of tremor with minimal complications.
2 Grosset, D. (2009). Clinical diagnosis of parkinsonism and tremor. In M. Okun, K. Grosset, H. Fernandez, D. Grosset (Eds.), Parkinson’s Disease: Clinican’s Desk Reference (pp. 33). Boca Raton, Florida: CRC Press.Find a Treatment Center for PD
“All of a sudden, I mean, it just hits you. The relaxation was so instantaneous. It didn’t come on slowly. It was like. one minute you’re all tense. And the next minute you just relax. It’s the best feeling in the world. Yeah, I mean, feel like you can breathe. Like you’re flying.”
– Marie Baker, Treatment Patient
Treatment and Benefits
Discover how Incisionless Focused Ultrasound can diminish or eliminate symptoms safely and effectively — without a scalpel, hospital stay, or lengthy recovery time.
- Incisionless Surgery
Means little to no risk of infection.1
- No General Anesthesia Required
No invasive burr holes or implants.
- Improvement in Hand Tremor
Stably maintained at 3 years.1
- Personalized Treatment
With sub-millimeter target movement.
- Single Session Treatment
with minimal hospitalization.
- Safe and Effective
With minimal side effects.1
Insightec sponsored a pivotal trial of the Exablate Neuro platform to evaluate MRI-guided focused ultrasound thalamotomy to treat patients with medication-refractory tremor-dominant Parkinson’s disease (PD).
Median tremor scores improved 51.9% versus 12.7% for the treatment and sham groups, respectively, at 3-month follow-up.1 There was a trend of improvement from baseline observed in the Exablate-treated group not seen in the sham group which persisted through 12-month follow-up.
Insightec-sponsored clinical studies have shown that the most common adverse events associated with this treatment included numbness/tingling (7%), imbalance (4%), gait disturbance (2%), and unsteadiness (1%).
The number in parentheses is the percentage of subjects who experienced the side effect.
Most of these events were classified as mild or moderate, and 58% resolving on the same day as treatment or within one week of treatment. Two treatment-related severe AEs were reported: one subject experienced ataxia/hemiparesis (weakness on one side of the body) which resolved in 30 days and one subject experienced severe hemiparesis. It should be noted that improvements in training, targeting, MR thermal monitoring, and cavitation detection have advanced since the study was conducted.
For additional safety information, please refer to Pre-Market Approval (PMA) P150038
Important Safety Information
You should have a detailed conversation with your physician regarding complications, also known as adverse events, that you may experience.
Insightec-sponsored clinical studies have shown that the most common adverse events experienced after treatment included: 1) imbalance/gait disturbance (26%), 2) numbness/tingling (33%), and 3) headache/head pain (51%). Most of these events were classified as mild or moderate, and 48% of all adverse events resolved on their own within 30 days.
Adverse events that persisted at 3 years were all mild or moderate and included: numbness/tingling (9%), imbalance (4%), unsteadiness (4%), gait disturbance (2%), and musculoskeletal weakness (2%). Additional infrequent events include dizziness, taste disturbance, slurred speech, fatigue, and vomiting.
The number in parenthesis is the percentage of active subjects experiencing these adverse events.
For details of the clinical study methods and results, download Clinical Study Results. For additional safety information, please refer to Pre-Market Approval (PMA) P150038
The Exablate Neuro is intended for use in the unilateral Thalamotomy treatment of idiopathic Essential Tremor patients with medication-refractory tremor. Patients must be at least age 22. The designated area in the brain responsible for the movement disorder symptoms (ventralis intermedius) must be identified and accessible for targeted thermal ablation by the Exablate device.
Click here to view the regulatory approvals of Insightec products by country.
From working diligently toward medical advances, to providing holistic community support, Advocacy groups like the ones below champion both patients and the healthcare professionals treating them.
Focused Ultrasound Foundation (FUSF)
Focused Ultrasound Foundation. FUSF was created to improve the lives of millions of people with serious medical disorders by accelerating the development and adoption of focused ultrasound.Visit Website
PMD Alliance offers opportunities for people impacted by Parkinson and other movement disorders to learn, live more fully and connect to a support community.Visit Website
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