FDA grants breakthrough designation to targeted lung denervation system
Nuvaira Inc. announced that its targeted lung denervation system for patients with COPD has been designated as a breakthrough device by the FDA.
The Nuvaira lung denervation system is designed to reduce moderate to severe COPD exacerbations in patients on optimal medical care. The targeted lung denervation system involves a catheter-based bronchoscopic procedure to disrupt pulmonary nerve input to the lung and reduce clinical consequences of neural hyperactivity. The catheter delivers radiofrequency energy to the nerves located on the outside of the airways. The procedure lasts about 1 hour. The technology demonstrated safety and feasibility in previous peer-reviewed clinical studies performed in patients with COPD, according to a company press release.
In March, the FDA reviewed safety data on the first 50 patients enrolled in the AIRFLOW-3 pivotal trial and then granted full investigational device exemption approval to complete the 400-patient study. In April, CMS approved the AIRFLOW-3 trial for the purposes of Medicare coverage, according to the release.
The AIRFLOW-3 pivotal trial is enrolling participants with COPD aged 40 to 78 years who are randomly assigned to targeted lung denervation plus optimal medical care or a sham procedure with optimal medical care only. Primary endpoint is moderate or severe COPD exacerbations within a 12-month period. Secondary endpoints include time to first exacerbation, change in St. George’s Respiratory Questionnaire-COPD Version total score, change in FVC and FEV1 and time to first respiratory-related hospitalization.
“We support our global pulmonary thought leaders who are working hard to ensure patient access to routine care and to important clinical trials like AIRFLOW-3 while simultaneously adapting to the new reality of COVID-19,” Dennis Wahr, MD, CEO of Nuvaira, said in the release.
Healio previously reported results of the AIRFLOW-2 study, in which targeted lung denervation in addition to optimal pharmacotherapy was associated with fewer respiratory events, including exacerbations, compared with pharmacotherapy alone.
The Nuvaira lung denervation system is not yet commercially available in the U.S.