Abstract: A heart valve prosthesis for replacing a native mitral valve includes a self-expanding frame with a plurality of anchoring members disposed along the lower region. A valve body is positioned within the self-expanding frame and includes a plurality of leaflets configured to allow blood flow through the self-expanding frame in only one direction. A skirt surrounds the self-expanding frame and is spaced apart therefrom for contacting surrounding tissue and impeding blood flow around the self-expanding frame. The skirt may be reinforced with wires to help maintain a desired shape. The leaflets in the valve body are preferably connected to the self-expanding frame through one or more intermediate components such that the valve body is spaced radially inwardly from an inner surface of the self-expanding frame.

Abstract: An introducer for an endoluminal prosthesis and a methods for delivering a prosthesis within a body vessel are described. The introducer comprises pusher catheter having a lumen extending therethrough, the lumen being in communication with an opening formed in the sidewall of the pusher. A sheath is disposed over the pusher catheter and also has an opening formed in its sidewall. The sheath is longitudinally movable relative to the pusher catheter between a prosthesis delivery position and a prosthesis deployment position. When the sheath is in the deployment position, the opening formed in the sidewall of the pusher catheter is at least partially longitudinally aligned with the opening formed in the sidewall of the sheath. A wire may extend though the opening in the sheath, the opening in the pusher, through the lumen of the pusher and through a fenestration in a prosthesis to cannulate a branch vessel.

Abstract: The present invention relates to a prosthesis delivery device and to a handle assembly located at the distal end of the delivery device. The handle assembly has a main handle and a nut disposed on the main handle. The nut has a first configuration in which the nut is engaged with the outer surface of the main handle and a second configuration in which the nut is disengaged from the outer surface of the main handle. Disengaging the nut from the main handle facilitates quick sheath retraction and deployment of at least the distal end of the prosthesis as well as recapturing the proximal end of the device within the sheath.

Abstract: Devices, systems and methods are described herein a prosthesis for implantation within a lumen or body cavity and delivery systems for delivering the prosthesis to a location for implantation. A delivery system can include a plurality of components, including a flexible nose cone, multi-layer sheath, and pre-compressed shaft, which can be moveable relative to each other.

Abstract: A delivery device and methods for deploying an endovascular prosthesis within the common and internal iliac arteries are described. The device comprises a pusher catheter having a proximal end and a pusher extension extending proximally therefrom. A tubular prosthesis having a side branch is releasably coupled to the pusher extension. An extension dilator extends proximally from the proximal end of the pusher catheter, extends at least partially along an external surface of the main tubular body, into a distal end of the side branch and exits a proximal end of the tubular prosthesis. The extension dilator can be tracked over a guide wire which serves to both position the device within a vessel and also to facilitate cannulation of an internal iliac artery.

Abstract: A prosthesis can be configured to grasp intralumenal tissue when deployed within a body cavity and prevent axial flow of fluid around an exterior of the prosthesis. The prosthesis can include an expandable frame configured to radially expand and contract for deployment within the body cavity and a valve body. The expandable frame can include a frame body and a supplemental frame. The valve body can include a plurality of leaflets and one or more intermediate components. The one or more intermediate components can couple at least a portion of the leaflets to the expandable frame. The prosthesis can include an annular flap positioned around an exterior of the expandable frame.

Abstract: The present invention relates to a deployment handle for a prosthesis delivery device and to a delivery device including such a handle. The handle assembly facilitates the controlled release of a prosthesis from the delivery device, while ensuring that various deployment steps are performed in a particular sequential order. The handle assembly comprises a main handle and a second handle which is rotatably and/or longitudinally moveable relative to the main handle. The second handle has an initial position on the main handle such that it prevents access to, and premature manipulation of, a proximal stent release mechanism, until the stent graft has been at least partially unsheathed.

Abstract: A pre-loaded stent graft delivery device having a guide wire catheter and a handle including a multi-port manifold with access ports, where an access sheath extends from each access port. A sheath is disposed coaxially around the guide wire catheter and includes two splits that enable the retraction of the sheath while the access sheaths are disposed within the respective access port of the manifold.

Abstract: A mitral valve prosthesis includes an expandable frame having a proximal end, a distal end, and a middle portion. A plurality of tips extend from the proximal end of the frame for attachment to a delivery catheter. A plurality of anchors are disposed along the distal end of the frame and extend toward the proximal end for engaging tissue. An outer circumferential portion extends around the middle portion of the frame and is positioned radially outwardly of the frame. The outer circumferential portion preferably increases in diameter along a distal direction. A distal end of the outer circumferential portion is located distal of free ends of the anchors when the expandable frame is deployed. A valve body is positioned within an interior of the expandable frame and includes leaflets adapted to allow flow in a first direction and prevent flow in a second direction.

Abstract: A delivery system for delivering an endovascular prosthesis is disclosed. A handle assembly is disposed at the distal end of the delivery system. The handle assembly includes a main handle and a second handle disposed at least partially on the main handle and rotationally moveable relative to the main handle. A trigger wire release mechanism is operatively coupled to the second handle. A sheath is operatively coupled to the second handle, such that rotation of the second handle relative to the main handle retracts the sheath in a distal direction. Rotation of the handle also moves the trigger wire release mechanism from a first position to a second position to retract one or more trigger wires.

Abstract: The present embodiments provide system and methods for deploying an endoluminal prosthesis. In one example, the system comprises a sheath, and a stent-graft disposed within the sheath in a delivery state. A pusher having proximal and distal sections is disposed at least partially within the sheath in the delivery state. An orientation marker is disposed on the pusher. The orientation marker extends less than 360 degrees around a circumference of the pusher.

Abstract: The present embodiments provide systems and methods for deploying at least a portion of a stent. In one embodiment, the system comprises a cannula having an outer surface, and at least one coiled member having proximal and distal ends and a plurality of turns disposed therebetween. One of the proximal and distal ends of the coiled member is secured to the outer surface of the cannula, and the other of the proximal and distal ends of the coiled member is unsecured relative to the outer surface of the cannula. A portion of a stent is looped around the unsecured end of the coiled member and disposed within spacing between adjacent turns of the coiled member. Rotation of the cannula subsequently causes the portion of the stent to disengage from the coiled member.

Abstract: Methods for delivering and deploying an endovascular graft to the common and internal iliac arteries are described. A system including a pre-loaded delivery device with a releasably attached extension cannula and an extension sheath for use with such methods is also described.

Abstract: A valve prosthesis can be configured to be deployed within a native heart valve and prevent axial flow of fluid around an exterior of the prosthesis. The prosthesis can include an expandable frame configured to radially expand and contract for deployment within the native heart valve, a flap assembly positioned around an exterior of the expandable frame, a proximal end of the flap assembly being positioned at or proximate a proximal end of the expandable frame. In some embodiments, the flap assembly can extend outward from the frame and have an expanded configuration configured to create a barrier to fluid flow exterior to the frame when deployed within the native heart valve.

Abstract: The present embodiments provide systems and methods for deploying at least a portion of a stent. In one embodiment, the system comprises a cannula having an outer surface, and at least one coiled member having proximal and distal ends and a plurality of turns disposed therebetween. One of the proximal and distal ends of the coiled member is secured to the outer surface of the cannula, and the other of the proximal and distal ends of the coiled member is unsecured relative to the outer surface of the cannula. A portion of a stent is looped around the unsecured end of the coiled member and disposed within spacing between adjacent turns of the coiled member. Rotation of the cannula subsequently causes the portion of the stent to disengage from the coiled member.

Abstract: A delivery system for delivering an endovascular prosthesis is disclosed. A handle assembly is disposed at the distal end of the delivery system. The handle assembly includes a main handle and a second handle disposed at least partially on the main handle and longitudinally moveable relative to the main handle. A trigger wire release mechanism is disposed in the interior or the main handle. A sheath is operatively connected to the second handle, such that longitudinal movement of the second handle relative to the main handle retracts the sheath in a distal direction. Movement of the trigger wire release mechanism from a first position to a second deployed position is prevented when the sheath is in the first position. Methods for accessing the iliac arteries and deploying an endovascular prosthesis therein using the delivery system and handle assembly are also disclosed.

Abstract: A prosthesis delivery device and method of using the same is described. The delivery device comprises a rotatable inner cannula extending from a proximal end to a distal end with a prosthesis releasably coupled to the proximal end. A delivery handle assembly is disposed at the distal end of the delivery device. The handle comprises a first handle disposed about the inner cannula, a rotary dial rotatably disposed about a distal end of the first handle and a second handle disposed about at least a portion of the distal end of the first handle. The second handle is longitudinally moveable relative to the first handle between a first position wherein the sheath is coaxially disposed about the prosthesis and rotation of the rotary dial is prevented, and a second position wherein the sheath is retracted distally to expose at least a portion of the prosthesis and rotation of the dial is permitted.

Abstract: The present embodiments provide stent-grafts. In one embodiment, a stent has proximal and distal ends, a plurality of strut segments disposed between the proximal and distal ends that enable expansion of the stent from a compressed state to a deployed state, and a series of distal apices disposed at the distal end of the stent. At least a portion of a first distal apex overlaps with graft material. First and second sutures are each coupled between a portion of the first distal apex and the graft material. The first and second sutures are positioned at different longitudinal zones that lack an axial overlap with one another.

Abstract: A prosthesis can be configured to grasp intralumenal tissue when deployed within a body cavity and prevent axial flow of fluid around an exterior of the prosthesis. The prosthesis can include an expandable frame configured to radially expand and contract for deployment within the body cavity and a valve body. The expandable frame can include a frame body and a supplemental frame. The valve body can include a plurality of leaflets and one or more intermediate components. The one or more intermediate components can couple at least a portion of the leaflets to the expandable frame. The prosthesis can include an annular flap positioned around an exterior of the expandable frame.