FAQs
How to order?
PATI will be available to order soon for patients, Medical Institutions, and Government Entities. Please be patient with us as our distribution capabilities are currently being developed. In the meantime, to get on our distribution list click here.
What is this device, and what makes it unique?
This is the first-of-its-kind, FDA-cleared prescription rescue device designed to facilitate seizure management during emergencies. It protects against oral injuries and facilitates airway management during seizures. Its innovative design allows for safe placement in the mouth, unlike traditional methods such as spoons, towels, or fingers, which can be hazardous.
How does this device change the standard of care for seizures?
Traditionally, managing seizure emergencies has been limited by the lack of a safe, approved device for oral placement. This device finally enables healthcare providers and caregivers to administer seizure rescue in a safe, controlled manner without risking injury or airway obstruction, significantly improving patient safety. It offers a standardized, effective approach to seizure intervention, potentially reducing emergency room visits and injuries.
Why is this device considered a breakthrough?
Because it is the first FDA-cleared device specifically designed for oral placement during seizures, it fills a critical gap in emergency seizure management. Unlike other methods that rely on manual intervention with fingers or hazardous objects, this device is designed for safety, ease of use, and consistency, setting a new standard for seizure rescue protocols.
How does this device improve safety during a seizure?
The device protects against all injuries and facilitates airway management during seizures. Its single-use, tear-away pouch design ensures safe, hygienic, and effective placement, reducing the risk of oral injuries, choking, or airway obstruction caused by improper intervention.
Who can prescribe and use this device?
The device is FDA-cleared for prescription use by licensed physicians. It can be used in outpatient settings, during emergencies, or in inpatient care. Caregivers and trained medical professionals can administer it under proper guidance.
What types of seizures is this device indicated for?
It is indicated for a broad range of seizure types, including those caused by epilepsy, traumatic brain injury or concussion, other neurological conditions, overdose situations, and any emergency scenario where seizure management is required.
Why is this device important for patients and caregivers?
It provides a safe, reliable, and easy-to-use tool to manage seizures effectively, particularly in emergency situations. It empowers caregivers to intervene quickly and confidently, potentially preventing injuries and improving patient outcomes.
How does this device compare to traditional methods like spoons or fingers?
Traditional methods such as inserting fingers, spoons, or towels into the mouth are unsafe and can cause injury or airway obstruction. This device is specifically designed for safe placement, reducing these risks and providing a standardized approach to seizure rescue.
Why are sports mouthguards or dental guards not appropriate for seizure management?
Sports mouthguards and dental guards are designed for protection during physical activity and do not have the safety, testing, or approval for use during seizure emergencies. They have not been tested or approved for airway management or injury prevention in seizure contexts, and their use could pose risks such as airway obstruction or choking. Our device is specifically designed, tested, and FDA-cleared for seizure rescue to ensure safety and effectiveness.
How does this device impact the overall management and treatment of seizure disorders?
By offering a safe, effective, and FDA-cleared rescue option, it enhances emergency response protocols, reduces the risk of injuries, and potentially decreases reliance on more invasive or hazardous interventions. It represents a significant advancement in seizure care, especially for patients with frequent or difficult-to-control seizures.
What are the next steps for adoption and integration into clinical practice?
The device is currently in final stages of discussions with treatment facilities and is expected to be prescribed by physicians for outpatient use. Education and training will be key for effective adoption, and ongoing research will support its integration into standard seizure management protocols.
Why does this device need to be prescribed by a healthcare provider?
The device is FDA-cleared as a prescription medical device because it is intended for use under the guidance of a healthcare professional to ensure proper placement, usage, and safety. Prescription status also helps ensure that caregivers and patients receive appropriate training, and that the device is used in suitable clinical contexts for optimal safety and effectiveness.
Why is this device limited to single use?
The device is designed for single use to maintain strict hygiene, ensure the integrity of the device, and prevent cross-contamination or infection. Single-use design also guarantees that each device is sterile and fully functional when used, providing maximum safety during seizure management. Reusing such devices could compromise safety and efficacy.