AF Ablation: Finding the Right Mix

Article preview from Medtech Insight - September, 2010

For a number of reasons, 2009 was a big year for the atrial fibrillation ablation market. Early in the year, Biosense Webster received FDA approval for its radiofrequency ablation catheter, the first such device to launch in the US with a specific AF indication. That approval was much more than just a landmark event for J&J; it changed the landscape of the AF industry, reinvigorating interest in the funding and development of new catheter-based technologies--a trend that has extended through to 2010 and will likely continue in the years ahead.

AF Ablation: Finding the Right Mix

Article preview from Medtech Insight - September, 2010

For a number of reasons, 2009 was a big year for the atrial fibrillation (AF) ablation market. Early in the year, Biosense Webster Inc. (a division of Johnson & Johnson [J&J]) received US Food & Drug Administration (FDA) approval for its NaviStar ThermoCool radiofrequency (RF) ablation catheter, the first catheter ablation device on the US market with a specific AF indication. That milestone helped usher in several high-profile acquisitions undertaken by competitors jostling for a stake in this highly promising, yet still greatly underserved space. In fact, FDA approval of the NaviStar ThermoCool was much more than just a landmark event for J&J; it changed the landscape of the AF industry, opening doors and reinvigorating interest in the funding and development of new catheter-based technologies—a trend that has extended through to 2010 and will likely continue in the years ahead.

Research on catheter ablation for AF also has entered a new stage. Several important trials have demonstrated the superiority of catheter ablation versus antiarrhythmic drugs (AADs) for the treatment of paroxysmal (intermittent) AF, establishing the procedure as a viable and effective treatment strategy, although it is not yet widely accepted as a first-line therapy. Now that the first ablation catheter has received FDA approval for AF, clinical trials for new ablation devices will likely shift away from comparisons of devices versus AADs and move toward comparisons between new and approved devices—an important transition that is likely to make it easier to enroll patients in future studies.

But challenges to treatment still persist. While catheter-based AF ablation (and specifically pulmonary vein [PV] isolation) is now an accepted therapy for paroxysmal AF, it does not work for everyone, and there is still no clear cut way to identify which patients are most likely to benefit. Moreover, the data demonstrating the effectiveness of catheter ablation for persistent and long-standing AF remain less robust, and large-scale prospective, randomized, controlled studies comparing ablation to drug therapy in these more complex patients are still needed.

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