This designation is given to medical devices with the potential to more effectively treat diseases that are life-threatening or irreversibly debilitating. It aims to expedite the development, assessment, and review of such devices, so they can be brought to the market more quickly if shown to be effective.
Cala Health, the device’s developer, is planning to open clinical trials in Parkinson’s patients with action hand tremors this year. These studies will be conducted virtually, meaning participants will have the chance to use the device at home, with regular check-up visits with a neurologist done over the phone or via a computer. Those interested in participating may learn more about these studies here.
“Cala Health is committed to pursuing rigorous scientific and clinical research to demonstrate the mechanism, benefits, usability, and safety of our technologies,” Kate Rosenbluth, PhD, the founder and chief scientific officer of Cala Health, said in a press release.
“We are pleased to have the FDA recognize the novelty and potential for our wrist-worn neuromodulation therapy,” Rosenbluth said.
“While hand tremor in patients living with Parkinson’s disease typically occurs when the arm is at rest while sitting or walking, it is also estimated that more than half of patients also experience action tremor,” said Stuart Isaacson, MD, director of the Parkinson’s Disease and Movement Disorders Center of Boca Raton, in Florida.
“Furthermore, published data suggest that levodopa, the primary treatment for motor symptoms of Parkinson’s disease, is not usually effective in treating this type of tremor, which can negatively affect performing daily tasks like eating and writing,” Isaacson added.
A treatment for action tremor “remains a significant unmet medical need” for these patients, he said.
Cala Trio is worn around the wrist like a watch. The device is designed to send small electrical signals that stimulate tremor-associated nerve cells in the wrist to normalize their activity, easing hand tremors. Conceptually, its mode of action is similar to deep brain stimulation, a surgical treatment for Parkinson’s.
Its approval for essential tremor was supported by data from a clinical trial, called PROSPECT (NCT03597100). Using the device in two 40-minute sessions per day for three months was seen to effectively reduced hand tremor severity in most people with essential tremor.
Essential tremor is characterized by Parkinson’s-like tremors, and for this reason, is often misdiagnosed as Parkinson’s. However, essential tremor is not associated with the disease’s other motor symptoms, such as slow movement and muscle stiffness.
According to Cala Health, many people with Parkinson’s experience the same action tremors as those with essential tremor, which is what prompted the company to seek this FDA designation for Cala Trio.
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