CryoCor a-fib trial
This article was originally published in The Gray Sheet
Executive Summary
The San Diego firm completes enrollment for pivotal clinical trial studying treatment of atrial fibrillation with its CryoCor cryoablation system Aug. 27. The system treats cardiac arrhythmias with cryonenergy, or extreme cold, to destroy targeted cardiac tissue. CryoCor has enrolled over 170 patients in the pivotal study and will conduct a 12-month follow-up for each patient. The company obtained FDA approval to market the device to treat atrial flutter in August and expects to receive approval for the atrial fibrillation indication in 2009. CryoCor is one of a handful of firms with ablation devices aiming to be the first to market with a-fib labeling...