During its analysts’ meeting in New York last month, St. Jude Medical (St. Paul, Minnesota) provided a detailed review of its worldwide operations. It specifically noted that atrial fibrillation (AF) is an important platform for its future growth, noting that ”after heart failure, AF represents the largest unmet clinical need in cardiovascular medicine today.”

This opportunity exists because of the morbidity of AF and the economic consequences of untreated and under- treated patients.

According to Jane Song, president of St. Jude’s Atrial Fibrillation division, “the safety and efficacy of current medical and traditional device treatment options do not meet clinical expectations.” The company has developed a multiple technology platform to better serve the AF market and meet the needs of electrophysiologists (EPs) and cardiac surgeons, the two key physician customers.

Song noted that St. Jude generated about $254 million in worldwide revenue from its AF franchise in 2005, a hefty share of the estimated global market of $790 million. For this year, the company hopes to achieve AF revenue in the $290 million to $310 million range, which again represents a significant portion of an estimated $880 million global market for 2006.

Both percutaneous catheter and surgical ablation are being aggressively addressed. Song indicated that about 40,000 ablation procedures were performed in the U.S. in 2005, which represents less than 2% of the potential population. Impressively, ablation procedures grew 54% between 2004 and 2006. Surveys show that 65% of EPs cite ablation as the No. 1 clinical procedure that they wish comprised more of their workload.

Meanwhile, proposed guidelines from the Heart Rhythm Society (Washington) will move AF ablation to the second choice after medical management. Previously, it had been slotted as No. 3.

Clinical efficacy for AF catheter ablation continues to improve, with several centers showing efficacy rates in the 80% or higher range. St. Jude will be the exclusive sponsor for the Catheter Ablation Versus Anti-Arrhythmic Drug Therapy for Atrial Fibrillation (CABANA) trial, which will randomize catheter ablation to drug therapy. The pilot study is expected to begin by mid-2006, with a pivotal trial, which could enroll up to 3,000 patients, starting after completion of the pilot phase. The National Institutes of Health (Bethesda, Maryland) will be involved in this landmark trial.

St. Jude also will be involved in two surgical trials, both using HIFU as its energy source. Through its minority interest in ProRhythm, the company will begin enrolling patients in 2Q06 in an AF trial to treat paroxysmal AF. The protocol calls for 240 patients to be randomized 1:1 vs. medical management.

In addition, a trial using the Epicor HIFU device will start in 3Q06, treating patients with this device concomitant to either CABG or valves procedures. The study aims to demonstrate the safety and efficacy of HIFU therapy vs. a surgery only group.

Song noted that St. Jude is “well-positioned to lead the development of this market, with our focused investments in technology, clinical, training and educational programs.”

— Larry Haimovitch, CDU Contributing Editor

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