2 results
Approved WMOCompleted
Demonstrate that the observed incidence of procedure and/or device related incidence of new stroke (excludes transient ischemic attack) within 30 days of an ablation procedure (index or reablation) with the Phased RF System is less than 1.8% with…
Approved WMOCompleted
To determine the efficacy and safety of the CardioFit system for the treatment of subjects with systolic heart failure who have failed to achieve symptom relief through standard evidence-based management per applicable guidelines.