ST. PAUL, Minnesota — Device maker St. Jude Medical Inc. (NYSE:STJ) won Food & Drug Administration approval to begin enrolling patients in a clinical trial of a radiofrequency cardiac catheter ablation system.
The trial will examine the safety and efficacy of the company’s Duo 12 catheter system for treating patients suffering from atrial fibrillation, or abnormal heartbeat, according to a press release.
The trial is expected to last three years, involve 324 patients, and take place in both U.S. and international markets. It will involve patients afflicted with paroxysymal atrial fibrillation, a type of irregular heartbeat that begins suddenly and ends spontaneously.
Patients will be treated with a noninvasive procedure known as ablation, which refers to the removal of tissue via erosion or vaporization.
The trial “marks an important milestone for St. Jude Medical because it could result in the company’s first atrial fibrillation indication for a catheter ablation system in the U.S.,” said Jane Song, president of the St. Jude’s atrial fibrillation division.
St. Jude reported last week that fourth-quarter sales in its cardiac rhythm management division fell one percent. The division’s annual revenues grew three percent, mostly from international sales. U.S. sales were flat.
