Adagio Gives Afib Cold Treatment in Hot Market

Adagio Medical is vying to get its treatment for persistent atrial fibrillation treatment on the market. The Laguna Hills, CA-based company made significant progress toward the goal this week and announced it received an IDE from FDA. The firm is developing a catheter procedure involving an energy source that freezes tissue. Adagio said its intelligent continuous lesion ablation system (iCLAS) encompasses the One- Shot+ catheter, a corresponding console, and a protective esophageal balloon to mitigate the effects of the cold beyond the localized area of ablation. The anatomical approach requires a single transseptal puncture to reach the targets in the left atrium. The same catheter is used for navigation, ablation, and validation of the lesions. The firm’s study is set to support a PMA application for the treatment of patients with Afib that has persisted more than seven days but less than twelve months, who have not had prior Afib ablation therapy. Research centers will include both private practice and academic sites in the US, Canada, and Europe. “Adagio has been working diligently toward, and is extremely pleased with, this important corporate milestone,” Nabil Jubran, VP of Regulatory Affairs and Quality, said in a release. “We have started the approval process of our clinical sites and may have patients enrolled and treated by the fall. We are pleased with the strong interest expressed by the clini...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Business Source Type: news