Catheter ablation technology developer Endosense announced that its TactiCath Quartz contact force-sensing ablation catheter has been used for the first time in the U.S. in a catheter ablation procedure at the University of Virginia Medical Center in Charlottesville.
The procedure was performed as part of an amended protocol of an investigational device exemption clinical study of TactiCath. Endosense said it expects to use the results of the study to file a premarket approval application with the U.S. Food and Drug Administration in the fourth quarter of 2013.
Endosense began to sell the TactiCath catheter in Europe in December 2012 after receiving CE Mark approval earlier that year in June.
The device features a new force sensor designed to provide increased stability and precision. It does not require preprocedure calibration, according to the Geneva-headquartered company. It also has a significantly smaller equipment footprint than the company's prior TactiCath model, a user-friendly graphical interface, and enhanced signal processing and digital output that facilitates connectivity with imaging devices and other equipment in a cardiac catheterization laboratory.
