CSA Medical, Inc. Receives FDA Breakthrough Device Designation and IDE Approval for its RejuvenAir System for COPD Patients with Chronic Bronchitis

Today CSA Medical announced that its RejuvenAir System has been designated as a Breakthrough Device by the U.S. Food and Drug Administration (FDA) and received unconditional IDE (Investigational Device Exemption) approval to initiate a pivotal clinical study to treat patients with moderate to severe chronic obstructive pulmonary disease (COPD) with chronic bronchitis (CB). The RejuvenAir® System utilizes a Metered Cryospray of liquid nitrogen at -196◦C to targeted areas within the lungs.

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.”

Note: The RejuvenAir® Metered Cryospray™ System is designed to spray liquid nitrogen at -196◦C in a circumferential pattern within the airway. It is anticipated that the rapid freezing of the epithelial layer of the airway walls will destroy the mucus-producing goblet cells while preserving the extracellular matrix, thereby enabling the regrowth of healthy cells. The RejuvenAir® System is currently under clinical investigation and is not commercially available. 

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides our readership with breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The ArthroFree system is the first FDA-cleared wireless camera for arthroscopy and general endoscopy, both areas of minimally invasive surgery. The system is designed to help surgeons work with aximum dexterity and focus.
The project, which was led by the University of Southern California, included large increases in representation among men of African, Hispanic and Asian ancestries, that were contributed in part by an ongoing collaboration between the U.S. Department of Veterans Affairs and DOE reports Argonne.
This innovative software turns smartphones into medical-grade stethoscopes, allowing people to capture, analyze, and share critical heart health data with medical personnel from the comfort of any location notes Sparrow BioAcoustics.
"Taewoong Medical becoming an Olympus group company is also a major milestone in our global growth strategy," said Henry Shin, CEO of STARmed. "We look forward to our products being made available to more patients through Olympus' global distribution network."
The company reports they have successfully met the six-month primary endpoint for the first-ever female patient implanted with the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) to treat SUI.

By using this website you agree to accept Medical Device News Magazine Privacy Policy