The Coldplay Cryoballoon Full Ablation System and the Coldplay Cryoballoon Swipe Ablation System from C2 Therapeutics has received FDA 510(k) clearance.
The newly approved editions to the C2 Therapeutics portfolio are designed to treat Barrett's esophagus.
"The U.S. regulatory clearance of the promising Coldplay Full and Swipe Ablation Systems is a major leap forward in the care of patients with Barrett's Esophagus at risk for development of esophageal cancer," said George Triadafilopoulos, MD, clinical professor of gastroenterology and hepatology at Stanford (Calif.) University. "These technologies provide endoscopists with more options to eliminate Barrett's Esophagus and improve patient outcomes."