Abstract: An introducer sheath assembly includes an expandable introducer sheath including an expandable braid defining an elongate tubular member moveable between a collapsed configuration for delivery and an expanded configuration for deployment, the expandable braid having a first length when in the collapsed configuration and a second, reduced, length when in the expanded configuration. The introducer sheath assembly includes a dilator adapted to releasably hold the expandable introducer sheath in its collapsed configuration for delivery until the dilator is actuated to release the expandable braid from the dilator, thereby permitting the expandable braid to expand to its expanded configuration.

Abstract: A delivery system for delivering a stent-valve may include an inner shaft including a distal tip, a stent-valve crimped onto the inner shaft, a distal sheath disposed over at least a lower portion of the stent-valve, and a proximal sheath disposed over at least an upper portion of the stent-valve. The distal sheath has a proximal free end with an angled proximal edge defining a short side and a long side of the distal sheath. The proximal sheath is actuatable independently from the distal sheath, and moveable proximally to release the upper portion of the stent-valve. The distal sheath is moveable distally to release the lower portion of the stent-valve. The angled proximal edge releases a first side of the lower portion of the stent-valve before an opposite second side.

Abstract: An improved guidewire may include an elongate shaft including a distal section and a proximal section extending proximally from the distal section. The elongate shaft includes a coiled portion disposed within the distal section. The coiled portion is curved in a first direction in a first plane. The elongate shaft includes a reverse curve portion curved in a second direction opposite the first direction. The reverse curve portion is disposed proximal of the coiled portion. A kit for forming the improved guidewire may include a guidewire having a coiled portion and a forming tool configured to form a reverse curve portion in the guidewire proximal of the coiled portion.

Abstract: A heart valve remodeling device may include a delivery device including an inner shaft slidably disposed over a guidewire and an outer shaft slidably disposed over the inner shaft, and a braided stent fixedly attached to the inner shaft and the outer shaft. The braided stent may be translatable between an elongated configuration and a deployed configuration by movement of the inner shaft relative to the outer shaft. The braided stent may include a valve having two or more leaflets disposed within the braided stent. Adjacent leaflets of the two or more leaflets may form longitudinally-oriented commissures proximate a perimeter of the valve, the commissures being fixedly secured to the braided stent along their length.

Abstract: A heart valve remodeling device may include a delivery device including an inner shaft slidably disposed over a guidewire and an outer shaft slidably disposed over the inner shaft, and a braided stent fixedly attached to the inner shaft and the outer shaft. The braided stent may be translatable between an elongated configuration and a deployed configuration by movement of the inner shaft relative to the outer shaft. The braided stent may include a valve having two or more leaflets disposed within the braided stent. Adjacent leaflets of the two or more leaflets may form longitudinally-oriented commissures proximate a perimeter of the valve, the commissures being fixedly secured to the braided stent along their length.