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MR-guided focused ultrasound —incisionless therapy for essential tremor and Parkinson’s disease.

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Essential Tremor1,2

Unilateralandstaged,bilateral MR-guided focused ultrasound.

5-year study results demonstrate significant and sustained tremor improvement.

73.8%

Improvement in tremor severity at 5-years (CRST Part A).

Focused ultrasound has been shown to be safe for treating essential tremor with minimal risk.

Most adverse events were mild and resolved within 6 months.

Reported adverse events following unilateral focused ultrasound treatment for essential tremor

Refer your patients for focused ultrasound.

Revolutionary treatment for essential tremor, now approved to treat both sides.1,2

Parkinson’s Disease 3

Staged bilateral pallidothalamic tractotomy (PTT) for the treatment of advanced Parkinson’s disease.

Study summary:

The Insightec-sponsored study included 54 patients treated at 9 centers. The majority (74%) of the participants (40) went on to receive staged, bilateral treatments. Second-side treatments were staged at least 6 months from the first side.

AVERAGE IMPROVEMENT

MDS-UPDRS III – Total

• Off Medications (tremor, bradykinesia, rigidity)
• 17.7-point improvement from baseline
• Reported at month 3, sustained at 12 months.

AVERAGE IMPROVEMENT

MDS-UPDRS IV

• 7.1-point improvement in motor complications (dyskinesia, fluctuations) from baseline
• Reported at month 3, sustained at 12 months.

SAFETY INFORMATION:

Majority of side effects were not clinically significant and 80% resolved in 3 mos or less. The most common adverse events were hypertension, imbalance, and falling. One related serious adverse event (anarthria) was reported in 1 patient (out of 40). No life-threatening events related to device or procedure occurred

Parkinson’s Disease4

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 Disease5

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.

1. Essential Tremor – P150038
2. Essential Tremor Staged, Bilateral – P150038/S022
3. Parkinson’s Disease Motor Complications, Staged, Bilateral (PTT)- P150038/S037
4. Parkinson’s Disease-Tremor Dominant – P150038/S006
5. Parkinson’s Disease Motor Complications (GPi) – 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/safetyinformation/. For detailed approved indications please visit: https://insightec.com/regulatory-approvals/
Results may not be representative of all treatment outcomes.

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