CSA Medical has received CE Mark approval for its RejuvenAir System for the treatment of Chronic Obstructive Pulmonary Disease (COPD) with Chronic Bronchitis (CB).
The RejuvenAir System is a cryosurgical device which applies Metered Cryospray ("MCS") of liquid nitrogen at -196◦C to targeted areas within the lungs through a bronchoscopic procedure. The extreme cold flash freezes damaged surface area lung cells which induces a rejuvenative healing process.
COPD with CB is a long-term, progressive lung disease that, over time, makes it hard to breathe. CB is characterised by a productive cough due to the overproduction of mucus and damaged cilia.
Heather Nigro, SVP of regulatory, quality and clinical affairs at CSA Medical, said: "While pharmaceutical options can decrease cough and mucus production, the RejuvenAir System offers the only treatment able to address the underlying cause of CB – while simultaneously treating the debilitating symptoms. This patient population now has an option that can dramatically improve their quality of life - that's exciting!"
The approval was supported by a prospective, multi-centre, open-label, safety and efficacy study. The 35-patient study led to a significant improvement in patient-reported health-related quality of life, at least up to 12 months. Treatment with the RejuvenAir System was well tolerated and did not result in any significant or unexpected safety events.
