The successful treatment of Atrial Fibrillation (AF) requires permanent electrical isolation of the pulmonary veins. The least invasive method available to physicians today requires the use of an ablation catheter to form complete and contiguous lesions around the pulmonary veins.
Limitations with current ablation technologies include minimal indirect assessment of endpoints and they provide little real-time direct feedback or imaging assistance to the Electrophysiologist. This makes it difficult to create adequate lesions, leading to a recurrence of AF in over 40% of cases after a single treatment.
The patented Direct Endocardial Visualization Ablation Catheter - IRIS™ System provides the clinician direct visualization of the targets, the ability to monitor the delivery of therapy and create lesions in an overlapping or contiguous manner.
This direct visualization enables physicians to assess local anatomy, confirm catheter position, monitor tissue contact and watch each ablation lesion as it forms. The immediate, direct visual feedback allows physicians to optimize therapy delivery to the tissue and create complete and contiguous lesions; a cornerstone of AF treatment.
Voyage Medical is currently enrolling patients in a feasibility study for the treatment of paroxysmal AF with the IRIS System outside the United States.