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.
“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
How It Works and How It Helps
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 associated with this treatment are headache/head pain (35%), dizziness (30%), numbness/tingling (30%), imbalance (20%), and gait disturbance (10%).
The most common treatment-related complications included numbness/ tingling (7%), imbalance (4%), gait disturbance (2%) and unsteadiness (1%). The number in parenthesis is the percentage of active subjects experiencing these adverse events.
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 details of the clinical study methods and results, download Clinical Study Results. For additional safety information, please refer to Pre-Market Approval (PMA) P150038
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.
PMD Alliance offers opportunities for people impacted by Parkinson and other movement disorders to learn, live more fully and connect to a support community.
A Better Tomorrow
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