Demand for non-drug intervention for atrial fibrillation will remain, despite FDA PVAC decision

According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, the search for an improved method of treating atrial fibrillation (AF) will be unaffected by the recent mixed decision by the Food and Drug Administration (FDA) panel on Medtronic's phased radiofrequency (RF) pulmonary vein ablation catheter (PVAC). The panel found that, while PVAC showed benefits over drug therapy, it did not meet the recommended safety endpoint.

The demand for a non-drug intervention for atrial fibrillation will remain”

Various companies in the electrophysiology mapping and ablation market are taking different approaches to treating atrial fibrillation. The same FDA panel gave approval to Atricure's Synergy Ablation System, which specifically targets patients undergoing open-heart surgery for either coronary artery bypass grafts or heart valve replacements. Medtronic, by contrast, has focused on improving the minimally invasive catheter ablation approach, targeting pulmonary vein isolation. Medtronic has previously successfully obtained approval for its Arctic Front, used for treating recurrent symptomatic paroxysmal atrial fibrillation.

Medtronic's PVAC has shown strong growth in Europe, where it obtained the CE mark in 2006 as an Ablation Frontiers product. According to data from MRG's Marketrack, the number of procedures in Europe that used the device more than doubled between 2009 and 2010. The penetration of this device into the facilities surveyed has also more than doubled in the same time period. It was approved in Canada in 2010. While the FDA is not mandated to follow the panel's advice, it typically does so, so approval is unlikely in the United States with the current safety profile.

Atrial fibrillation is the most common type of cardiac arrhythmia. The number of diagnosed cases of atrial fibrillation in the United States is expected to grow from 3.5 million in 2010 to 4.4 million in 2020, according to Decision Resources. While anti-arrhythmic drugs remain the first-line treatment for atrial fibrillation according to various clinical guidelines, the technique of AF ablation is increasingly popular, due to a growing amount of positive clinical data demonstrating efficacy. The number of such procedures performed annually will grow at an average of over 15 percent per year.

"The demand for a non-drug intervention for atrial fibrillation will remain," said MRG Senior Analyst Julie McLaughlin. "This is particularly true when addressing persistent atrial fibrillation, as Medtronic's PVAC attempts to do. This condition is extremely difficult to treat successfully, so there will continue to be a strong drive to produce and market a device that can do so while meeting appropriate safety and efficacy requirements."

In addition to Medtronic and Atricure, competitors in the active electrophysiology ablation market include Biosense Webster, St. Jude Medical, Boston Scientific, Philips Healthcare, Siemens Healthcare, GE Healthcare and C. R. Bard.

Recent Millennium Research Group reports covering the electrophysiology mapping and ablation device market include

European Markets for Electrophysiology Mapping and Ablation Devices 2012

BRIC Markets for Electrophysiology Mapping and Ablation Devices 2012

US Markets for Electrophysiology Mapping and Ablation Devices 2011