Reports of unusually high death rates for COVID-19 patients on ventilators have raised alarms, and some doctors are looking to reduce reliance on the breathing machines when possible. To advance that goal, Lungpacer Medical Inc., of Vancouver, British Columbia, has obtained an emergency use authorization (EUA) from the U.S. FDA for its Lungpacer diaphragmatic pacing therapy system (DPTS) for immediate use in ventilator patients at high risk of weaning failure, including patients with the novel coronavirus.

The nonsurgical, nonimplanted Lungpacer DPTS provides temporary, minimally invasive diaphragm stimulation by means of a central venous catheter, similar to those currently used with patients on ventilators. The catheter is used to deliver fluids and medication while also activating the diaphragm muscle using transvenous phrenic nerve stimulation. Electrical charges are triggered using the touchscreen on an external control unit, or with a hand-held controller.

Treatment is authorized for up to 30 days.

Frees up ventilators

The EUA comes as hospitals in areas hard hit by the coronavirus have struggled to meet the surge in demand for mechanical ventilators for the most severely ill patients. At the same time, a study in the Journal of the American Medical Association suggested that at least 80% of COVID-19 patients in New York City who received ventilator support had died – twice the number of patients with severe respiratory distress who typically die while on the machines.

“Hospital resources around the world have been under significant strain during the COVID-19 pandemic and ICU beds and mechanical ventilators have been at peak demand,” said Ali Ataya, an assistant professor within the division of pulmonary and critical care medicine at University of Florida Health in Gainesville and co-author of a report on the RESCUE 1 feasibility trial of the Lungpacer DPTS. “This novel therapy has the potential to wean patients earlier from the ventilator and free up resources during these difficult times.”

Decreasing the time a patient spends on a ventilator not only frees up resources and ICU beds. “About one third of patients on mechanical ventilation are difficult to wean, resulting in prolonged ventilation,” Dawn Bitz, vice president of clinical marketing and enrollment at Lungpacer, told BioWorld. “Prolonged ventilation raises the risks of the negative effects of positive-pressure ventilation, including ventilator-induced diaphragm dysfunction and ventilator-induced lung injury.”

Breakthrough status

The FDA granted the Lungpacer DPTS an expedited access pathway (EAP) designation in 2016, entitling it to priority review and more interactive communication with agency personnel. The EAP was the forerunner to the breakthrough devices program. The company has since completed two clinical trials and is enrolling patients in a pivotal IDE trial to support FDA approval.

The RESCUE 1 study was a single-arm feasibility trial with 11 patients to demonstrate that Lungpacer DPTS could be used for patients on prolonged mechanical ventilation. “The results showed improvements from baseline measures of respiratory function maximal inspiratory pressure (MIP, mITT, p = 0.02) and rapid shallow breathing index (RSBI, mITT, p = 0.04) in patients who successfully weaned from MV,” Bitz told BioWorld. “Most patients (77.7%) successfully weaned from mechanical ventilation during the 30-day trial.” No unanticipated device- or procedure-related adverse events or deaths were reported.

RESCUE 2 – a randomized, controlled, multicenter study in Europe with 110 patients – compared Lungpacer DPTS plus standard of care vs. standard care alone. The trial was completed in January and the results were provided to the FDA as part of the EUA request.

The randomized, controlled, pivotal RESCUE 3 trial launched in December 2018, and is enrolling up to 376 patients in the U.S. and Europe. Lungpacer will seek premarket approval of the class III device once all the trials are completed, Bitz said.

Lungpacer has raised a total of $75.4 million in two rounds, the latest a $55.8 million private equity financing in April 2019, according to Crunchbase. “We believe we have the capacity and plans in place to meet the anticipated demand,” Bitz said, adding the company will continue to monitor its cash needs as the device rolls out under the EUA.

Other EUAs targeting ventilator patients

This is the third breathing-related device in the past two weeks to get an FDA pass for use in critically ill coronavirus patients. On Monday, Pittsburgh-based Alung Technologies Inc. announced that it had scored an EUA for its Hemolung respiratory assist system to treat lung failure caused by COVID-19. The device, which works much like a dialysis machine to remove carbon dioxide from the blood and recirculate it with oxygen, is seen as a promising alternative to ventilators, particularly for patients who can’t tolerate mechanical ventilation.

Just days earlier, the agency granted an EUA to Vent Multiplexor LLC, a New Haven, Conn.-based startup, for a device that enables personalized support for two adults on a single ventilator.

No Comments