Based in Carlsbad of California, Cryterion Medical is engaged in the development of a single-shot cryoablation platform for the treatment of atrial fibrillation (AF).
Cryterion Medical cryoablation platform uses cryothermal energy to break the irregular electrical signals that can cause AF.
Developed with a next-generation balloon catheter, advanced mapping catheter, steerable sheath and enhanced console, the system will streamline overall procedural workflow, enhance maneuverability and improve positioning in challenging anatomy.
The addition of Cryterion’s cryoballoon platform enables Boston Scientific to have both cryothermal and radiofrequency (RF) single-shot and balloon-based ablation therapies in its portfolio.
Ablation therapy involves the delivery of RF (heating) or cryothermal (cooling) energy to the areas of the heart muscle responsible for the abnormal heart rhythm. Both types of energy can be used to separate pulmonary veins.
Cryterion Medical president and CEO Keegan Harper said: “Initial clinical study results demonstrate that our system has a promising safety profile as well as acute efficacy.”
The cryoablation system is being studied in a clinical study in Europe, and the data from the study will be used for CE mark regulatory submission, which is expected in early 2019.
The firm will also submit an investigational device exemption (IDE) application to the US Food and Drug Administration, based on the trail in which patient recruitment is expected to begin in 2019
Cryterion also manages offices in Montreal of Canada and Wexford of Ireland.
Boston Scientific rhythm management and global health policy senior vice president and chief medical officer Dr Kenneth Stein said: “The acquisition of Cryterion Medical enhances our AF ablation procedure offerings, allowing physicians to select a therapeutic option based on clinical preference and specific patient needs.
“We are committed to providing physicians with a comprehensive suite of therapies that lead the way for clinical advancements and address the needs of the increasing population of patients with AF.”
