RejuvenAir System Granted CE Mark Approval in Europe to Treat COPD With Chronic Bronchitis
CSA Medical‘s RejuvenAir System has been granted CE Mark approval in Europe for treating people with chronic obstructive pulmonary disease (COPD) who have chronic bronchitis — frequent inflammation of the bronchial airways.
RejuvenAir is a cryosurgical medical device designed to destroy cells on the surface of the airways that are producing excessive mucus.
The device uses a bronchoscope to reach the lungs, and releases extremely cold liquid nitrogen — up to -196°C (approximately -321°F) — in specific areas of the lungs. This minimally invasive procedure destroys the defective cells while promoting the rejuvenative healing process of the tissue.
The procedure is performed in an operating room under general anesthesia.
“While pharmaceutical options can decrease cough and mucus production, the RejuvenAir System offers the only treatment able to address the underlying cause of CB [chronic bronchitis] — while simultaneously treating the debilitating symptoms,” Heather Nigro, senior vice-president of regulatory, quality and clinical affairs at CSA Medical, said in a press release.
“This patient population now has an option that can dramatically improve their quality of life — that’s exciting!” Nigro added.
The CE Mark approval — required for many products before they can be sold in the EU — was supported by clinical evidence from an open-label study (NCT02483637).
The data demonstrated that treatment with RejuvenAir could lead to significant and clinically meaningful improvements in patient-reported, health-related quality of life for at least up to 12 months. The treatment was in general well-tolerated, and was not associated with significant or unexpected safety events.
“This is a promising new therapy for the millions of people who suffer from chronic bronchitis,” said Pallav Shah, MD, from the Royal Brompton in London.
The RejuvenAir System received breakthrough device designation from the U.S. Food and Drug Administration in April 2019 for the treatment of COPD. The U.S. regulatory agency also granted CSA Medical an unconditional investigational device exemption, allowing it to test RejuvenAir in an upcoming pivotal clinical trial. That trial will assess the system’s effectiveness in patients with moderate-to-severe COPD with chronic bronchitis.
The company is preparing the launch of a randomized, sham-controlled trial (NCT03893370) in 30 sites across the U.S., Canada, and Europe. It will enroll approximately 330 people with COPD, ages 40-80, who will be randomly assigned to undergo treatment with the RejuvenAir System or a sham procedure.
An estimated 12.7 to 14.7 million people in the U.S. have COPD. Around 11 million patients sought medical attention for chronic bronchitis, a subset of COPD, in 2011.
