Key Points
- Patients with advanced Parkinson’s disease now have the option to receive focused ultrasound on both sides of their brain in two sessions at least six months apart.
- The treatment for one side was cleared in 2021.
The US Food and Drug Administration (FDA) will now allow appropriate patients with advanced Parkinson’s disease (PD) to have focused ultrasound treatment – as an adjunct to medication treatment – on the second side of their brain. This ruling is an important milestone for the technology, as PD is a systemic disease with symptoms like rigidity and dyskinesia that can impact the whole body. A noninvasive bilateral treatment option like focused ultrasound will be a good choice for certain patients with advanced PD.
Affecting more than one million people in the US, PD is a neurodegenerative disease that has no cure and often affects both sides of the body. Traditional treatments for motor symptoms include drug therapy and invasive surgery (e.g., deep brain stimulation or radiofrequency lesioning).
In December 2018, the FDA approved Insightec’s Exablate Neuro focused ultrasound device to treat tremor-dominant PD, which affects approximately 10-20% of the Parkinson’s population. In November 2021, this approval was expanded to include those suffering with mobility, rigidity, or dyskinesia symptoms. For certain patients, focused ultrasound offers a noninvasive alternative to surgery with a lower risk of complications and lower cost. It is important to note that focused ultrasound – and all current therapies – only address the PD symptoms and not the primary disease.
Now, patients who have undergone focused ultrasound treatment on one side can have the second side treated at least six months after the initial procedure. This second side procedure is also called a staged bilateral treatment.
The FDA’s decision was based on data from a clinical trial conducted at nine centers across the US, Europe, and Asia that investigated staged bilateral pallidothalamic tractotomy (PTT) in patients with PD and demonstrated encouraging outcomes. Insightec indicates that full results from the study are expected to be published later this year.
“This is a tremendous milestone for not only the field of focused ultrasound but also patients suffering from this debilitating disease,” said Foundation Chairman Neal F. Kassell, MD. “We congratulate the team at Insightec and all of the investigators, including Daniel Jeanmonod, MD, who successfully pioneered this PTT technique.”