Edwards eSheath Optima introducer set

The Edwards eSheath Optima introducer set is a catheter introducer system used to facilitate entry of Edwards transcatheter heart valves into the patient's vasculature. It consists of a sheath, vessel dilator, introducer, and in-sheath dilator, all designed to enable introduction and removal of compatible interventional devices into the vascular system.

The device features a two-layer expandable sheath with an inner member that slides against itself and an outer elastomeric jacket that expands radially. Key modifications from the predicate include modified shaft dimensions, an elastomeric outer jacket for seamless expansion, a locking mechanism for the introducer, and an optional in-sheath dilator. The sheath includes radiopaque markers, a hydrophilic coating, hemostasis seals, and radiopaque components for improved fluoroscopic visibility.

Not stated in this summary.

The Edwards eSheath Optima introducer set is substantially equivalent to the predicate device (K200258) because both devices share the same intended use of facilitating entry of Edwards transcatheter heart valves into the vasculature. Although the new device incorporates technological modifications including elastomeric outer jacket design, modified shaft dimensions, a locking mechanism, and an optional in-sheath dilator, comprehensive bench testing across 26 performance parameters—including hemostasis, kink radius, tensile strength, biocompatibility, thrombogenicity, and delivery system interaction—demonstrates that these changes do not alter the fundamental function or safety profile, maintaining substantial equivalence.