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Diseases

FDA Approves Insightec's Exablate Neuro Platform for Staged Bilateral Pallidothalamic Tractotomy Treatment in Advanced Parkinson's Disease

Strategic Insights

— 2 min read

The U.S. Food and Drug Administration (FDA) has approved Insightec's Exablate Neuro platform for staged bilateral pallidothalamic tractotomy treatment in patients living with advanced Parkinson's disease. This new therapeutic option offers a lower risk profile compared to traditional surgical interventions and is incisionless, requiring no implanted hardware. Insightec's Exablate Neuro platform uses focused ultrasound to precisely treat targeted areas in the pallidothalamic tract, guided by MRI. The approval is a significant milestone for patients suffering from severe motor symptoms such as rigidity, bradykinesia, and dyskinesia due to Parkinson's disease.

Key Takeaways:

  • The FDA has approved Insightec's Exablate Neuro platform for staged bilateral pallidothalamic tractotomy treatment in patients with advanced Parkinson's disease, offering a new therapeutic option for those with severe motor symptoms.
  • The procedure is incisionless, does not require implanted hardware, and offers a lower risk profile compared to traditional surgical interventions.
  • The Exablate Neuro platform uses focused ultrasound to precisely treat targeted areas in the pallidothalamic tract, guided by MRI, providing a comprehensive bilateral treatment.
  • The clinical trial demonstrated encouraging outcomes, supporting FDA approval and paving the way for publication of full results later this year.
  • Insightec plans a limited launch of the bilateral procedure in select centers during 2025, along with ongoing efforts to establish routine reimbursement pathways to ensure broader patient access.
  • More than 25,000 patients have been treated with Insightec's Exablate technology for a variety of movement disorder indications at 197 centers worldwide, including 84 in the U.S.
  • The Exablate Neuro platform previously received FDA approval for unilateral treatment of medication-refractory essential tremor in 2016, tremor-dominant PD in 2018, unilateral pallidotomy for Parkinson's-related dyskinesia and motor symptoms in 2021, and staged unilateral treatment for ET patients on the contralateral (second) side.

Statistics:

  • The FDA has approved Insightec's Exablate Neuro platform for staged bilateral pallidothalamic tractotomy treatment in patients with advanced Parkinson's disease.
  • More than 1.2 million Americans are expected to be affected by Parkinson's disease by 2030.
  • Over 50,000 patients are expected to benefit from the expanded indication of the Exablate Neuro platform.
  • The Exablate Neuro platform has been used to treat over 25,000 patients at 197 centers worldwide, including 84 in the U.S.

Sources:

  • Insightec press release, July 8 (no date specified)
  • "Insightec Receives FDA Approval for Expanded Indication of Exablate Neuro Platform for Staged Bilateral Pallidothalamic Tractotomy Treatment in Patients Living with Advanced Parkinson's Disease"

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