Endosense, a medical device manufacturer based in Geneva, announced that it had successfully treated the first patient in the United States for a study of its TactiCath Quartz. The TactiCath Quartz is a cardiac catheter ablation device and will be entered for review by the United States Food and Drug Administration at the end of its trial, pending outcome.
The TactiCath Quartz is designed to treat cardiac arrhythmia in patients with heart disease. The device is the first of its kind: With a variety of new real-time feedback tools, the system gives physicians an additional way to monitor contact force during a surgical catheter ablation.
In June of 2012, the device earned its CE Mark clearance in the Europe Union. The device was commercialized in the E.U. less than 30 days ago. The current study will be used to supplement information from previous studies.
Jan Keltjens is the CEO of Endosense. In prepared remarks, she said, "The TactiCath Quartz brings several technical and functional advancements to the electrophysiology lab that further strengthen our leadership position in the field." She continued, "(This study) will pave the way for us to continue to offer electrophysiologists and their patients the most advanced contact-force sensing technology available, once we achieve anticipated approval in the United States."