+25,000
Global
treatments**
Transforming lives.* Incisionless therapy for movement disorders.
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Essential Tremor1
Unilateral and staged, bilateral MR-guided focused ultrasound.
5-year study results demonstrate significant and sustained tremorimprovement.
Download the 5-year clinical summary results73.8% Improvement in tremor severity at 5-years (CRST Part A).
Overall, focused ultrasound has been shown to be safe for treating essential tremor with minimal risk.
Most adverse events were mild and resolved in 6 months.
For complete safety data: https://insightec.com/safety-information
Reported adverse events following unilateral focused ultrasound treatment for essential tremor.
Revolutionary treatment for essential tremor, now approved to treat both sides.1
Download our referral brochure here
Announcing FDA approval of staged, bilateral pallidothalamic tractotomy to treat motor symptoms and complications of Parkinson’s disease.2
Stay informed – opt in to receive updates about this latest indication!
Parkinson’s Disease3
Unilateral MR-guided focused ultrasound for tremor dominant Parkinson’s disease.
53%
improvement in
functional disability
(CRST part C).
40%
improvement in quality
of life (QUEST).
Tremor-motor function significantly improved (CRST A+B composite)
Parkinson’s Disease4
MR-guided focused ultrasound for motor complications of Parkinson’s disease.
Unilateral MR-guided focused ultrasound pallidotomy is indicated for patients over 30 with confirmed diagnosis of idiopathic Parkinson’s disease.
Significant improvement,
in motor complications and motor symptom severity following focused ultrasound treatment of the GPi.
26.4%
Improvement in MDS-UPDRS Part III OFF at 3 months
46.1%
Improvement in MDS-UPDRS Part IV
No severe or life threatening events.
Primary efficacy responder analysis.
The most common complications reported by subjects in Insightec-sponsored clinical studies after treatment included: imbalance/gait disturbance, numbness/tingling, and headache/head pain. Additional infrequent events include dizziness, taste disturbance, slurred speech, fatigue and vomiting.
Persistent complications at three-years included: imbalance, unsteadiness, gait disturbance, musculoskeletal weakness and numbness/tingling.
- P150038/S015
- PMA50038/S037
- P150038/S006
- P150038/S014
*Referring to the significant improvement in quality of life.
** Insightec data on file
SAFETY INFORMATION:
Focused ultrasound treatment has been shown to be safe for treating essential tremor and Parkinson’s Disease certain indications, but as with any medical procedure, there are risks. For safety information, please visit: https://insightec.com/safety-information/. For detailed approved indications please visit: https://insightec.com/regulatory-approvals/
Results may not be representative of all treatment outcomes.
