St. Jude Medical gets FDA approval to begin clinical trial of cardiac ablation catheter system

ST. PAUL, Minnesota — Device maker St. Jude Medical Inc. has received U.S. Food and Drug Administration approval to begin enrolling patients in a clinical trial of a catheter system that uses radio frequency energy to destroy abnormal heart tissue.

The trial will study 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 statement from the company.

The trial is expected to last three years, involve 324 patients and take place in both the U.S. and international markets. It will involve patients afflicted with paroxysmal 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.