The Ampcare Effective Swallowing Protocol (ESP™) Therapy System received an extended clarification Wednesday from the U.S. Food & Drug Administration for the Intended Use in the prevention and treatment of swallowing disorders following post-traumatic conditions, including the coronavirus (COVID-19).
The FDA clarification confirms that the Ampcare Effective Swallowing Protocol (ESP) Therapy System is indicated for the prevention and treatment of post-extubation dysphagia (PED), due to disuse atrophy resulting from ventilator support and/or feeding tube support. The FDA clarification specifically includes the COVID-19 patient population.
“After reviewing our request, the FDA has determined that the COVID-19 patient population and treatment of dysphagia proposed in our FDA clearance is within the scope of our intended use. This will allow us to promote our system to include the COVID-19 patient population consistent with the labeling in the cleared 510(k), K131222,” said Russ Campbell, President of Ampcare.
Ampcare, a leader in certifying and training Speech & Language Pathologists (SLPs) and others to treat people with swallowing difficulties, is a TechFW client and headquartered in Fort Worth.
“We are extremely grateful the FDA acknowledged our company as being able to provide the medical community an option by giving a clear protocol for treating people with swallowing disorders post-extubation, including COVID-19 patients. This could not have been accomplished without the assistance of our regulatory team. We are grateful to partner with Ken Block Consulting, who understands our products and led our successful interaction with the FDA,” said Campbell.
Many COVID-19 patients with acute respiratory infection and respiratory insufficiency, as well as other ICU patients, have been treated with intubation, mechanical ventilation and feeding tubes. Intubation is a procedure that is used when you can’t breathe on your own. A tube is inserted down your throat and into your trachea to make it easier to get air into and out of your lungs.
A machine called a ventilator mechanically pumps in air with extra oxygen. The ventilator then helps you breathe out air that is full of carbon dioxide (CO2), and helps keep your oxygen and CO2 at healthy levels.
Extubation, when the tube is removed, can cause PED (resulting in difficulty with swallowing), especially with critically ill patients. Nearly 60% of patients who are intubated in intensive care units experience PED, and 40-50% of those patients experience aspiration, according to an Ampcare news release. Aspiration is known to cause pneumonia and lead to prolonged hospitalization and, in some cases, death.
The FDA designation acknowledges that Ampcare’s ESP therapeutic exercises and neuromuscular stimulation of the necessary muscles for swallowing should be considered in the prevention and the treatment of swallowing disorders for all patients, including those with or recovering from COVID-19.
Medical professionals, including SLPs, must be trained and certified before using Ampcare’s ESP products.