CSA Medical Completes Enrollment in Mechanism of Action Study Utilizing the RejuvenAir® System for COPD Patients with Chronic Bronchitis
These results should provide the scientific proof behind the remodeling response and clinical improvements identified in earlier studies.
The RejuvenAir System received CE mark last year, and this post-market study aims to identify molecular and cellular targets in the central airways of patients before and after MCS treatment to determine the mechanism which enables metered cryospray to rejuvenate damaged airways in Chronic Bronchitis patients.
The RejuvenAir System is a revolutionary cryosurgical device which applies Metered Cryospray ("MCS") of liquid nitrogen at -196◦C to targeted areas within the lungs through a minimally invasive bronchoscopic procedure. The extreme cold flash freezes damaged surface area lung cells which induces a rejuvenative healing process.
CSA Medical, Inc. Receives FDA Breakthrough Device Designation and IDE Approval for its RejuvenAir System for COPD Patients with Chronic Bronchitis
4/3/19: 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.