Cala Trio is a non-invasive, wrist-worn device designed to treat hand tremors. It uses transcutaneous afferent patterned stimulation (TAPS) to target brain pathways, providing on-demand relief. FDA-cleared for essential tremor, it offers a prescription-based solution without surgery or medication.
1.1 What is Cala Trio?
Cala Trio is a groundbreaking, non-invasive, wrist-worn medical device designed to provide targeted therapy for hand tremors. It utilizes transcutaneous afferent patterned stimulation (TAPS) technology to deliver electrical impulses to the median and radial nerves in the wrist. These impulses are calibrated to interrupt abnormal brain activity responsible for tremors. The device is specifically designed for individuals with essential tremor (ET) and can also be used to address tremors associated with Parkinson’s disease. Cala Trio is a prescription-only therapy, meaning it must be prescribed and calibrated by a healthcare professional to ensure personalized treatment. Unlike invasive procedures such as deep-brain stimulation, Cala Trio offers a safe, wearable solution that provides on-demand relief without the need for surgery or medication. Its compact design resembles a smartwatch, making it discreet and easy to use in daily life. By targeting the same brain pathways as invasive therapies, Cala Trio represents a significant advancement in the treatment of tremor conditions, offering both efficacy and convenience.
1.2 Overview of Its Use
Cala Trio is a non-invasive, prescription-only medical device designed to provide on-demand relief from hand tremors. It is specifically intended for individuals with essential tremor (ET) and can also be used to address tremors associated with Parkinson’s disease. The device is worn on the wrist and operates by delivering gentle electrical impulses to the median and radial nerves through transcutaneous afferent patterned stimulation (TAPS). These impulses are tailored to interrupt the abnormal brain activity that causes tremors, offering personalized relief. Patients can activate the device as needed, making it a convenient solution for managing tremors in daily life. Cala Trio is calibrated by a healthcare professional to ensure optimal effectiveness and safety for each user. Its design is user-friendly, resembling a smartwatch, and it can be adjusted via a companion app to customize treatment settings. The device is cleared by the FDA for the treatment of action tremors in adults with essential tremor, making it a groundbreaking option for those seeking non-surgical and drug-free therapy.
How Cala Trio Works
Cala Trio uses transcutaneous afferent patterned stimulation (TAPS) technology, delivering electrical impulses to the median and radial nerves in the wrist. These impulses disrupt abnormal brain activity, reducing hand tremors. It’s a non-invasive, FDA-cleared solution.
2.1 The Technology Behind It
Cala Trio operates using a proprietary technology called transcutaneous afferent patterned stimulation (TAPS). This method involves delivering precisely calibrated electrical impulses to specific peripheral nerves in the wrist, such as the median and radial nerves. These nerves are connected to brain regions responsible for motor control, particularly the ventral intermediate nucleus of the thalamus, which is often hyperactive in individuals with tremors.
The device is worn on the wrist and contains sensors that detect tremor patterns. It then generates electrical impulses tailored to interrupt abnormal brain activity, thereby reducing tremor severity. The therapy is non-invasive, avoiding the need for surgical implants or medication. Cala Trio’s technology is FDA-cleared for treating essential tremor and has been recognized for its innovative approach to managing movement disorders.
The system is programmed by a healthcare provider to match the individual’s tremor characteristics, ensuring personalized treatment. This customization allows for effective and consistent relief from hand tremors, making it a groundbreaking solution in neurology.
2.2 Nerve Stimulation Process
Cala Trio employs a unique nerve stimulation process called transcutaneous afferent patterned stimulation (TAPS). This involves delivering low-level electrical impulses to the median and radial nerves in the wrist through small, non-invasive electrodes. These nerves are directly connected to the brain’s motor control centers, particularly the ventral intermediate nucleus of the thalamus, which is often hyperactive in individuals with tremors.
The device is calibrated by a healthcare provider to detect and analyze the patient’s specific tremor patterns. Once activated, it generates electrical impulses that interrupt the abnormal brain activity causing the tremors. This process creates a competing signal that reduces the severity of hand tremors, providing on-demand relief without the need for surgery or medication.
The stimulation process is tailored to each patient’s condition, ensuring personalized therapy. The non-invasive nature of Cala Trio makes it a safe and convenient option for managing tremors, offering significant benefits for individuals seeking to regain control over their daily activities.
Conditions Treated
Cala Trio is FDA-cleared to treat essential tremor and Parkinson’s disease tremors. It provides non-invasive, on-demand relief for hand tremors, improving quality of life without surgery or drugs.
- Essential Tremor
- Parkinson’s Disease Tremors
It targets specific nerves to reduce tremor severity, enhancing daily activities.
3.1 Essential Tremor
Cala Trio is specifically designed to address essential tremor (ET), a common movement disorder characterized by involuntary shaking of the hands during voluntary movements or when maintaining posture. ET can significantly impact daily activities, such as writing, eating, and social interactions, reducing quality of life. Cala Trio offers a breakthrough solution by providing non-invasive, on-demand relief from hand tremors. Unlike traditional treatments that often rely on medications or invasive surgeries, Cala Trio uses transcutaneous afferent patterned stimulation (TAPS) to target the brain pathways responsible for tremors.
The device is calibrated by healthcare providers to individual tremor patterns, ensuring personalized therapy. Clinical studies have shown that Cala Trio reduces tremor severity by up to 88%, offering significant improvement for patients. Its wearable design makes it convenient for daily use, allowing patients to manage their tremors discreetly and effectively. By targeting the median and radial nerves in the wrist, Cala Trio interrupts abnormal brain signals, providing immediate and sustained relief.
For many patients, Cala Trio has become a game-changer, reducing reliance on medications and improving motor function. It is particularly beneficial for those who experience tremors during specific tasks or activities, offering a portable and user-friendly solution to manage symptoms effectively.
3.2 Parkinson’s Disease Tremors
Cala Trio has shown promise in addressing tremors associated with Parkinson’s Disease (PD), a neurodegenerative disorder that affects movement. Parkinsonian tremors often occur at rest but can also appear during movement, significantly impacting daily life. While Cala Trio is currently FDA-cleared for essential tremor, clinical evidence suggests its potential benefits for PD patients.
The device works by delivering transcutaneous afferent patterned stimulation (TAPS) to the wrist, targeting nerve pathways linked to tremor generation in the brain. This non-invasive approach offers an alternative to traditional treatments like deep-brain stimulation, which requires surgery. Cala Trio’s ability to reduce tremor severity and improve motor function aligns with the needs of PD patients seeking effective symptom management.
Studies and real-world data indicate that Cala Trio can reduce tremor severity in PD patients, enhancing their quality of life. Its portability and ease of use make it a viable option for those seeking non-pharmacological therapies. While further research is ongoing, Cala Trio represents a promising advancement in managing Parkinson’s Disease tremors.
Clinical Evidence
Clinical studies demonstrate Cala Trio’s effectiveness in reducing tremor severity, with real-world data showing significant improvement in patient outcomes. Research highlights its ability to provide sustained relief, enhancing quality of life for individuals with essential tremor and related conditions.
4.1 Key Studies
Several key studies have demonstrated the efficacy and safety of Cala Trio for treating essential tremor. A pivotal study presented at the Virtual ISPOR Europe 2020 conference highlighted its ability to significantly reduce tremor severity in real-world settings. Another notable study published in 2021 at the International Parkinson and Movement Disorder Society (MDS) virtual congress showed that Cala Trio provided sustained relief, with patients experiencing a substantial reduction in hand tremor amplitude. These studies utilized calibrated, individualized therapy, which was tailored to each patient’s tremor patterns. The data underscored Cala Trio’s non-invasive approach as a viable alternative to traditional treatments like deep-brain stimulation. Researchers also emphasized its user-friendly design, allowing patients to manage their symptoms independently. The results from these studies have been instrumental in supporting Cala Trio’s FDA clearance and its recognition as a breakthrough device for tremor management. Overall, the evidence consistently supports Cala Trio’s effectiveness in improving quality of life for individuals with essential tremor.
4.2 Real-World Data
Real-world data on Cala Trio has further validated its effectiveness in treating essential tremor. Studies conducted in clinical and home settings have shown that the device consistently reduces hand tremor severity, with patients reporting improved dexterity and daily functionality. Data collected from thousands of users indicates that Cala Trio maintains its efficacy over time, with many patients experiencing sustained relief from tremors. Additionally, real-world usage has highlighted the device’s ease of use and high patient satisfaction rates. The non-invasive nature of Cala Trio has made it accessible to a broader population, including those who may not be candidates for surgical interventions. Insurance coverage for Cala Trio has also been expanding, reflecting its growing recognition as a viable treatment option. These real-world insights complement clinical trial results, reinforcing the device’s role in improving the quality of life for individuals with essential tremor.
FDA Clearance and Recognition
Cala Trio has received FDA clearance as a non-invasive treatment for essential tremor. Its designation as a Breakthrough Device highlights its innovative approach to targeting tremors without surgery, marking a significant advancement in neurological care.
5.1 Breakthrough Device Designation
The FDA granted Cala Trio the Breakthrough Device Designation, recognizing its innovative approach to treating essential tremor. This designation accelerates the development and review process for devices that offer significant improvements over existing treatments. Cala Trio qualified due to its non-invasive nature and ability to target tremor pathways in the brain without surgery or medication. This designation highlights the device’s potential to address unmet needs in tremor management, particularly for patients seeking alternatives to invasive procedures. The Breakthrough Device program underscores the FDA’s commitment to advancing cutting-edge technologies that improve patient outcomes. As a result, Cala Trio has gained regulatory priority, streamlining its path to market and ensuring timely access for patients. This recognition also supports insurance coverage discussions, as it validates the device’s clinical significance and innovation in neurology.
5.2 FDA Clearance Details
Cala Trio received FDA clearance as a non-invasive, wrist-worn device for treating action tremors in adults with essential tremor. It is the only FDA-cleared, prescription-only wearable therapy designed to address this condition. The clearance was based on clinical evidence demonstrating its safety and effectiveness in reducing hand tremors. Cala Trio uses transcutaneous afferent patterned stimulation (TAPS) to target brain pathways responsible for tremor generation, offering a novel alternative to invasive treatments. The device is calibrated by a healthcare provider to individualize therapy, ensuring personalized treatment. FDA clearance underscores its potential to improve quality of life for millions affected by essential tremor. While primarily approved for essential tremor, studies are exploring its efficacy in managing tremors associated with Parkinson’s disease, further expanding its therapeutic potential. This clearance highlights the FDA’s recognition of Cala Trio as a groundbreaking solution in neurology, paving the way for broader adoption and insurance coverage discussions.