ViaOne Epicardial Access System

The ViaOne Epicardial Access System is a sterile, single-use access tool designed to reach the epicardial surface of the heart through a subxiphoid incision. It uses a concealed needle within a leading channel to facilitate guidewire access into the pericardium, enabling delivery of diagnostic and therapeutic interventions for ventricular tachycardia.

The ViaOne has a 17.5 Ga. needle with an 11 Fr. device profile (two-thirds smaller than the predicate's 18 Fr.), uses an engagement element for tissue retraction rather than vacuum, requires fluoroscopy but not endoscopic visualization, and employs needle advancement limits. Both devices are single-use, EtO-sterilized, use radiopaque distal tips, and follow identical operating principles for accessing and pre-dilating the pericardial sac.

ISO 10993-1 (biocompatibility), ISO 11135-1 (sterilization validation), ISO 11070:2014 (verification testing for outer tube surface and rim analysis), and simulated use testing per standard protocols.

Although the ViaOne uses different tissue retraction mechanics (engagement element vs. vacuum), it achieves the same functional result of safely isolating pericardial tissue in a sealed compartment. The smaller needle diameter and device profile pose no additional safety risk because the needle is concealed and functions identically to puncture the pericardium. All performance testing, biocompatibility, sterilization, animal studies, and clinical trial data demonstrate the device performs safely and effectively with adverse events consistent with established epicardial access procedures, supporting substantial equivalence in intended use and safety profile.