“The Spin You Put on It…”
At the Holiday Inn, Hugh Calkins found himself at the center of a pecking party. His presentation of Cardima’s REVELATION catheter ablation system had not gone over well.
The chief argument he made for the REVELATION system was that it had to be better than the current alternative to the drag and burn, which was pulmonary vein isolation, the very procedure that he’d let Richard Wu practice on my wife 14 months earlier.
Hugh Calkins told the FDA that pulmonary vein ablation, which he was promoting and practicing at the time, was neither safe nor sound. At the same time that he was recruiting patients for the procedure on his website, advertising a proven and effective therapy that cured Dave Erdman the mountain climber, he was telling government regulators that “the safety and efficacy of pulmonary vein ablation was unknown then [in 2000] and it is unknown now.”
It seemed extraordinary to no one in the room that a doctor was telling the Food and Drug Administration, an agency designed to safeguard the public, that he has been performing a procedure which he considers to be dangerous and unproven…