Health officials in Europe OK’d CSA Medical’s cryotherapy system to treat chronic obstructive pulmonary disease (COPD) with chronic bronchitis.
The system applies metered sprayed liquid nitrogen at -196 C to areas within the lungs through a minimally invasive bronchoscopic procedure. The cold flash freezes damaged lung cells which induces a rejuvenative healing process.
COPD with chronic bronchitis is a progressive lung disease that, over time, makes it hard to breathe. Chronic bronchitis is characterized by a productive cough due to the overproduction of mucus and damaged cilia. According to the American Lung Association, chronic bronchitis affects more than 11 million Americans and is the third leading cause of disease-related deaths.
“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,” Heather Nigro, SVP of regulatory, quality and clinical affairs at CSA Medical, says in a statement.”This patient population now has an option that can dramatically improve their quality of life – that’s exciting.”
The approval in the EU of this technology was supported by a prospective, multi-center, open-label, safety and efficacy study. The 35 patient study led to improvements 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.
“RejuvenAir metered cryospray can be safely delivered in patients with COPD and demonstrates clinical meaningful improvements in quality of life and patient-reported outcome scores out to 12 months,” Professor Pallav Shah, MD, FRCP. from the Royal Brompton, London, says in a statement. “This is a promising new therapy for the millions of people who suffer from chronic bronchitis.”