The FDA has granted 510(k) clearance to C2 Therapeutics’ Coldplay Cryoballoon Full Ablation System and its Cryoballoon Swipe Ablation System for the treatment of Barrett’s esophagus, the company announced.
“The clearance of Coldplay Cryoballoon Full and Swipe Systems is an important milestone in broadening the company’s portfolio,” Peter Garcia-Meza, president and CEO of C2 Therapeutics, said in a press release. “The Full and Swipe Ablation Systems will be critical in allowing physicians to ablate larger areas of tissue in endoscopic applications.”
According to the release, the technology behind these ablation systems involves a through-the-scope balloon catheter that is inflated and cooled at the same time by an inert refrigerant, which is delivered through a disposable handheld unit. Operating the systems is “intuitive, fast and cost-effective,” and they eliminate “the need for precise sizing, multiple deployment steps, and controller units,” the release said.
“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,” George Triadafilopoulos, MD, clinical professor of gastroenterology and hepatology at Stanford University, said in the release. “These technologies provide endoscopists with more options to eliminate Barrett’s esophagus and improve patient outcomes.”
Disclosures: Garcia-Meza is an employee of C2 Therapeutics, and Triadafilopoulos reports various financial relationships with C2 Therapeutics.