A meeting of the Circulatory System Devices Panel was held on June 27, 2007. The Panel discussed the submission, made several specific recommendations, and voted on a premarket approval application (P050024) for the CryoCor Cryoablation System.
The sponsor was seeking the following indications for use statement for the device: The device is intended for ablation of Isthmus-dependent atrial flutter in patients 18 years of age or older.
The CryoCor Cryoablation System is a catheter system that is designed to ablate cardiac tissue by extreme cooling for the treatment of atrial flutter. The system includes a console with an articulating arm housing a pre-cooler and a sterile, disposable, single-use percutaneous cryoablation catheter. The operation of the system is based on a two-stage evaporative refrigeration process that provides refrigeration power for the catheter. The replenishable primary refrigerant supply is housed in the console, from which coolant consumption is controlled and monitored. Localized ablation of tissue is achieved through extreme cooling of the catheter tip.
The sponsor presented data from a prospective single-arm study conducted with 160 subjects at 24 U.S. sites. The study used Objective Performance Criteria (OPC) to evaluate safety and effectiveness of the CryoCor System. Following presentations by the sponsor and the FDA, and after extensive deliberation, the Panel voted (8-2) in favor of Approvable with Conditions. Among the conditions of approval was a post-market study with specific endpoints recommended during the panel discussion, an on-site physician training program, and labeling modifications that were summarized during the panel discussion.
Contact: James Swink, Executive Secretary,
(240) 276-4179 James.Swink@fda.hhs.gov
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