Obstructive lung disease treatment developer Nuvaira said today that the FDA has designated its lung denervation system a breakthrough device.
The Nuvaira lung denervation system enables a novel bronchoscopic procedure that disrupts pulmonary nerve input to the lung to reduce the clinical consequences of neural hyperactivity, which causes airway hyper-responsiveness or “lung attacks” in both COPD and asthma.
The system is designed to reduce the risk of worsening moderate-to-severe chronic obstructive pulmonary disease (COPD) in patients on optimal medical care, according to Minneapolis-based Nuvaira. In March, the FDA’s review of safety data on the first 50 patients enrolled in Nuvaira’s Airflow-3 pivotal trial resulted in FDA investigational device approval for the company to complete the 400-patient study, Nuvaira noted. In April, the Centers for Medicare & Medicaid Services (CMS) approved Medicare coverage of the Airflow-3 trial.<…