CryoCath Reports Positive Data From AFIB Trial
CryoCath announced positive twelve month follow up data from the second and final cohort of 18 patients treated during the feasibility stage (33 patients total) of its STOP AF IDE trial. The results from the 12 month follow up confirm that 14 of the 18 subjects are free of Atrial Fibrillation (AFIB), with 12 of the 14 not taking any anti-arrhythmic drug (AAD) therapy. The trial, now in the pivotal stage, is assessing the Company's proprietary Arctic Front catheter to treat AFIB, the most prevalent cardiac arrhythmia affecting more than 4.3 million people worldwide.
Of the total 33 patients treated during the feasibility stage, the second cohort of 18 patients, who have been treated with 23mm or 28mm catheters as in the pivotal trial, has now completed the 12 month period. All patients from the second cohort were free of detectable AFIB at six months. Three of those patients required a second procedure which is permissible under the protocol set for the trial.
In the feasibility trial, the blanking period (where detectable AFIB is not considered a treatment failure) extends 60 days after the procedure. In the Pivotal IDE, as well as all current FDA-approved clinical trials, this blanking period has been extended to 90 days. Under this blanking period, the clinical success of the Arctic Front feasibility trial increased to 15 of 18 patients (83%) free from AFIB at twelve months, with 13 of those 15 patients off AAD therapy.
"The results from this study are very encouraging and strongly support the effectiveness hypothesis of the STOP AF trial," said Jean-Pierre Desmarais, Chief Scientific Officer, CryoCath. "In comparison to the 40 per cent success rate reported in medical literature using current AAD therapies, these results are outstanding and strongly suggest that we are creating permanent lesions, producing a significant clinical benefit."