Lung Denervation System Named FDA Breakthrough Device

Nuvaira‘s Lung Denervation System, under clinical investigation for its use in treating chronic obstructive pulmonary disease (COPD), has been designated a breakthrough device by the U.S. Food and Drug Administration (FDA).

This designation is given to devices that have the potential to substantially improve the treatment of serious diseases. It brings certain benefits — most notably, increased access to experts at the FDA for feedback and advice during clinical development, and likely priority review for regulatory submissions related to the device.

In lung denervation, a specialized catheter is inserted into the lungs. Radio waves are then used to destroy certain nerves thought to control airway constriction and mucus production. Eliminating these nerves usually helps reduce COPD exacerbations — a worsening or “flare up” of disease symptoms — which are a primary driver of poor clinical outcomes and high care costs.

Targeted lung denervation also may make other treatments, such as bronchodilators, more effective.

Early clinical data suggested that this procedure is generally safe and well-tolerated in people with COPD.

Now, the ongoing clinical trial AIRFLOW-3 (NCT03639051) is testing Nuvaira’s system for targeted lung denervation in people with COPD. The primary goal of the trial, which is sponsored by Nuvaira, is to determine whether the procedure reduces COPD exacerbations more than a sham model. That sham procedure uses the same catheter insertion but without the nerve-killing radio waves.

The trial also is assessing other outcomes to include quality of life, lung function, and hospitalization rates.

Most activity for AIRFLOW-3 had been ceased due to the ongoing global health pandemic. The Medical University of South Carolina recently became the first AIRFLOW-3 trial site to reopen.

“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, Nuvaira’s CEO, said in a press release.

The FDA in March reviewed safety data from the first 50 participants enrolled in the AIRFLOW-3 trial and approved the completion of the 400-patient study, the company said.

Nuvaira also announced the appointment of Tim Herbert, president and CEO of Inspire Medical Systems, to its Board of Directors. In addition, Medtech veteran Karen Peterson joined the executive team as vice president of clinical, regulatory and quality.