Synapse Biomedical, Inc. has received an Emergency Use Authorization for the emergency use of its TransAeris® DPS, to assist in weaning patients determined by their healthcare provider to be at high risk of weaning failure off of ventilators in healthcare settings during the COVID-19 pandemic for no more than 30 days.
During the COVID-19 pandemic, the surge of patients requiring prolonged mechanical ventilation (PMV) has put an unprecedented demand on hospital and ICU resources. Even when their primary symptoms have stabilized, these PMV patients are still at risk for developing ventilator-induced diaphragm dysfunction (VIDD)—further prolonging their ventilation.
The TransAeris system addresses this issue by conditioning a patient’s diaphragm to reduce or avoid VIDD. Models suggest the technology—which recently received CE Mark approval and is under clinical investigation in the U.S – could reduce ventilator burden in COVID-19 patients by 26 percent, helping to free up more ventilators in a time of great demand.
“More than 2,000 patients have been successfully treated world-wide with our diaphragm, pacing technologies,” said Anthony Ignagni, President & CEO of Synapse Biomedical. “We welcome the FDA’s leadership in providing this emergency pathway to get our latest TransAeris device into the hands of clinicians so they can help as many COVID-19 patients as possible during this pandemic.”
Emergency Use authorizations
Synapse has received Emergency Use Authorization (EUA) from the FDA for use of our TransAeris System(R) to treat patients during the COVID-19 pandemic. Pursuant to the EUA, a fact sheet for healthcare providers has been issued to outline the significant known and potential risks, as well as benefits, associated with the emergency use of ventilators. The fact sheet for patients must be provided to patients using EUA TransAeris and contains information to help them understand the risks and benefits associated with TransAeris to help wean patients from prolonged mechanical ventilation.
The TransAeris® Diaphragm Pacing System is designed to stimulate the diaphragm (breathing) muscle in order to improve breathing muscle strength. This, in turn, may reduce the amount of time needed to get off of the ventilator. The TransAeris® Diaphragm Pacing System may be used on patients during the COVID-19 pandemic who need to be placed on a ventilator. This device may allow patients to wean off of the ventilator in order to meet emergency demands for ventilators, critical care beds, and ICU personnel.
The TransAeris® Diaphragm Pacing System is a diaphragm pacing device designed to deliver small amounts of electricity to the diaphragm (breathing) muscle to make it move while using mechanical ventilation. TransAeris® is designed to stimulate the diaphragm muscle, one of your breathing muscles, in order to improve your breathing muscle strength. This, in turn, may reduce the amount of time needed to get you off of the ventilator.
Patients with COVID-19 and other illnesses or conditions that require mechanical ventilation, are not spontaneously breathing, and are expected to require prolonged ventilation.
Potential benefits of the TransAeris® Diaphragm Pacing System:
- Maintenance of diaphragm muscle strength to promote early weaning from the ventilator
- Avoidance of risks of being on the ventilator for a prolonged time, including pneumonia, lung injury, damage to your airway, and death
Potential risks of the TransAeris® Diaphragm Pacing System:
- Infection, breakage of the device, lung injury, pain due to stimulation, interference with your heart rhythm, bleeding, and, rarely, implant procedure related death
- Reduced familiarity of some healthcare providers with new devices such as the TransAeris® Diaphragm Pacing System
- Lack of effectiveness despite use as intended
A surgeon will place four temporary electrodes into the diaphragm (breathing) muscle using the most appropriate surgical approach for the patient’s condition.
After surgery, a healthcare provider will connect the electrodes to the TransAeris® diaphragm pacing device. The device will be programmed to use small amounts of electricity to help move the diaphragm without causing pain or discomfort. This movement will help improve the condition of the diaphragm.
Your healthcare providers will continue to use TransAeris until you no longer need a ventilator to breathe, or for a maximum of 30 days, whichever comes first.
Healthcare providers will discuss with you and your caregiver(s) the most appropriate options for the patient’s condition.
No. Your healthcare providers will remove the electrodes prior to discharge from the ICU, or after the electrodes have been in the diaphragm for 30 days, whichever comes first.
The TransAeris Diaphragm Pacing System has neither been cleared or approved for the indication to assist in weaning patients off ventilators in healthcare settings during the COVID-19 pandemic.
The TransAeris Diaphragm Pacing System has been authorized for the above emergency use by FDA under an EUA;
The TransAeris Diaphragm Pacing System has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the TransAeris Diaphragm Pacing System undersection 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.