Safety and Efficacy of a Novel Blunt-Tip Concealed-Needle Epicardial Access Device: First-in-Human Feasibility Study.

Epicardial access is becoming increasingly important for various cardiovascular interventions. Access to dry pericardial space can be challenging and is often associated with significant complications. A novel concealed-needle blunt-tip device is designed to capture the parietal pericardium layer and retract it into the distal end of the device, which houses a fixated concealed needle, in a bid to minimize the likelihood of lacerating the visceral layer of the pericardium. This prospective single-arm study evaluated the feasibility of use of this device in 11 human subjects with successful access attained in 91% (10 of 11) of cases without adverse events. (Pericardial Access With ViaOne Device; NCT05006157).