FDA-cleared, non-drug wearable, Encora X1, expands treatment options for veterans living with essential tremor
BOSTON–(BUSINESS WIRE)–#VAhealthcare–Encora Therapeutics today announced that Encora X1™, its FDA-cleared wearable for adults with essential tremor, is now available for order through the U.S. Department of Veterans Affairs (VA), expanding treatment options for veterans living with the condition.
More than 30,000 veterans receiving VA care had a recorded essential tremor diagnosis in a single year, according to a peer-reviewed national analysis of VA health records [https://tremorjournal.org/articles/10.5334/tohm.400].
For many, tremor can make ordinary tasks such as holding a cup, eating a meal, pouring a drink, writing, or using a phone difficult. Medications are typically the first line of treatment, but it doesn’t work for everyone, and side effects can limit its use. Encora X1 offers veterans and their care teams a non-drug, non-invasive approach to managing hand tremor using mechanical neurostimulation.
“Too many veterans with essential tremor have learned to adapt their lives around their tremor. They use two hands to hold a cup, avoid certain foods, or let someone else pour,” said Daniel Carballo, co-founder of Encora Therapeutics. “Making Encora X1 available through the VA gives veterans and their care teams another option when medication isn’t enough, isn’t well tolerated, or simply isn’t the right fit, and when they’re looking for an option that isn’t a drug and isn’t a procedure. We want veterans to be able to stay independent and keep doing the everyday things most of us take for granted.”
Essential tremor is one of the most common movement disorders, affecting an estimated 7.6 million people in the United States [https://tremorjournal.org/articles/10.5334/tohm.198]. It causes involuntary, rhythmic shaking, most often in the hands, that typically occurs during movement and can worsen over time.
Encora X1 is a wrist-worn device about the size of a smartwatch. It delivers gentle mechanical neurostimulation targeting the median, radial, and ulnar peripheral nerve distributions at the wrist. It can be used alongside medication or on its own and is designed to be worn throughout the day, allowing users to activate it when they want support with everyday activities.
Encora X1 may also fill an important treatment gap for patients who need a non-drug option and have an implanted electrical device, such as a pacemaker. Because Encora X1 uses mechanical rather than electrical stimulation, it has no electrical contraindications, giving physicians another option to consider when determining the appropriate treatment for their patients.
In clinical studies, device effects were observed within approximately 15 minutes of use. In a randomized, double-blind, sham-controlled study, 70% to 75% of participants achieved a one-point improvement in tremor-related disability during everyday tasks after 30 minutes of stimulation, compared with 48% of the sham group. And 96% of study participants rated Encora X1 therapy as “comfortable all of the time.” Individual results may vary.
Encora X1 is available for purchase by VA facilities through Lovell Government Services, an SBA-certified service-disabled veteran-owned small business contracted to process Encora X1 orders.
Veterans living with essential tremor can ask their VA care team whether Encora X1 is right for them. Encora X1 is available by prescription only.
About Encora Therapeutics
Encora Therapeutics is a Boston-based medical device company developing non-invasive neuromodulation therapies for people living with movement disorders. Founded by graduates of the Massachusetts Institute of Technology, Encora combines neuroscience, engineering, and human-centered design to develop treatment options that fit into everyday life.
The company’s first product, Encora X1, is an FDA-cleared, prescription wrist-worn device that uses mechanical neurostimulation to aid in the relief of hand tremors during stimulation in adults with essential tremor. Encora X1 can be used alongside medication or when first-line options have failed, weren’t tolerated, or were ruled out.
Learn more about VA ordering for Encora X1 and explore clinical and safety information at encoratherapeutics.com.
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