CD&D

Ablation Frontiers (Carlsbad, California) reported receiving FDA approval to extend U.S. enrollment in its clinical trial for interventional treatment of chronic AF.

The company says its Tailored Treatment of Permanent Atrial Fibrillation (TTOP AF) study is the first U.S. investigational device exemption trial of its kind. The TTOP AF trial is designed to compare the safety/efficacy of tailored ablation therapy against traditional pharmaceutical regimens, preliminary to seeking pre-market approval.

The company said that several patients have been randomized into the study. Initial U.S. treatment sites included the Lahey Clinic and Medical Center (Burlington, Massachusetts). The clinic’s first patient, with a three-year history of continuous AF, was treated and returned home the next day with a normal heart rhythm, the company said. Gregory Michaud, MD, performed the two-hour and 10-minute procedure.

Michaud said the system “has two advantages that are immediately apparent. One, the catheters are simpler to use than the traditional ‘point-by-point’ catheters, thus reducing the time it takes to complete complex left atrial procedures. Second, the depth of the radio frequency energy lesions is controllable, which makes damage to collateral structures, such as the esophagus, less likely.”

Designed to be a versatile tool kit for mapping and ablating areas of the heart where AF is most prevalent, the system combines a radio frequency (RF) energy source with a series of anatomically-designed catheters. Ablation Frontiers says its system is also unique because it does not require 3D navigation or robotic steering equipment.