Article preview from Start-Up - October, 2012
Three years ago, the FDA approved Johnson & Johnson’s ThermoCool, the first in a series of ablation catheters specifically designed to halt atrial fibrillation. Despite these advances, the long-term success rates of catheter ablation procedures remain low, opening the door for start-ups to devise new approaches.
Device Companies Follow New Map To Atrial Fibrillation
Three years ago, the FDA approved Johnson & Johnson’s ThermoCool, the first in a series of ablation catheters specifically designed to halt atrial fibrillation. Despite these advances, the long-term success rates of catheter ablation procedures remain low, opening the door for start-ups to devise new approaches.
In emerging fields of interventional cardiology, success tends to come only after halting progress. In coronary artery disease, angioplasty catheters cleared arteries but elastic recoil caused them to close again, requiring stents to prop them open. Then stents caused an immune reaction leading to restenosis. Drug-eluting stents came along to deal with the new problem. Today, revascularization procedures produce high rates of efficacy. Atrial fibrillation is following a similar path. Earlier versions of radiofrequency catheters overheated tissue, so the tips were irrigated with solution to slow the burn. Irrigation solved one problem but created another – interventionalists no longer could confirm ablation by temperature measurement at the tissue surface. So instead, sensors were developed to measure the force with which the ablation probe contacts tissue so to give physicians feedback about whether they’re creating a competent lesion.
In the case of atrial fibrillation, however, these incremental advancements have so far failed to result in compelling efficacy across all types of disease and patients. The rates of elimination of atrial fibrillation following catheter ablation range from 30 to 80% according to the type of patient and one’s definition of success, which depends upon whether you include one or more procedures and concomitant anti-arrhythmia drugs. (The single-procedure success rate of Johnson & Johnson’s RF catheter ThermoCool, as noted at its FDA panel approval hearing, was only 49%, for example.) That inadequate efficacy is the main reason why barely 4% of all patients eligible for catheter ablation of atrial fibrillation are getting the procedures. Many clinicians feel the risk is too high, the benefit too low, and the economics of these unpredictably long multi-hour procedures unappealing.
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