CSA Medical plans to initiate the pivotal study designed as a prospective, multi-center, blinded randomized (2:1) sham controlled trial using the RejuvenAir System across 30 sites in the U.S., Europe and Canada with up to 330 subjects. The study's Lead Principal Investigator will be Gerard J. Criner, MD, FACP, FACCP, chair and professor, Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, and director, Temple Lung Center.
COPD, which includes CB, is a long-term, progressive lung disease that over time makes it hard to breathe. According to the American Lung Association, the disease affects more than 11 million Americans and is the third leading cause of disease-related deaths.
"We are eager to begin this pivotal trial and build on the successful data that was generated from the feasibility study of RejuvenAir," stated Heather Nigro, senior vice president of regulatory, quality and clinical affairs at CSA Medical, who continued, "Receiving the Breakthrough Device designation from the FDA further highlights the unmet clinical need for this patient population and we are excited to drive the solution for moderate to severe COPD patients with chronic bronchitis."
The Breakthrough Devices Program is designed to facilitate the development and expedite the review of medical devices that provide for a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Benefits from this designation include early and more frequent contact with the FDA in an effort to collaborate and streamline development and regulatory approval.
Wendelin Maners, CSA Medical's president stated, "We are especially encouraged that the FDA approved the IDE unconditionally. The study approval and device designation will allow us to greatly impact the lives of Chronic Bronchitis patients worldwide and collect significant clinical data surrounding our novel system."