Abstract: Disclosed is an anchoring element for an implantable prosthesis that includes a barb, wherein the anchoring element, which includes a basal portion, comprises a thin layer of material, such as a cannula or sheet of metal, that extends or wraps at least partially around the strut of the prosthesis to which it is attached. The barb is configured to extend outward from the basal portion to penetrate adjacent tissue. The anchoring element is either permanently affixed to the strut, such as by laser or spot welding, crimping, or some other method of bonding, or allowed to slide longitudinally over the strut between two points or stops in order to relieve any excessive loads placed upon the barb that could cause fracture. The anchoring element and strut may be configured to limit axial rotation of the barb, while still allowing longitudinal movement. In another embodiment, the slidable anchoring element may be manipulated following initial deployment to reorient the barb toward the implantation site.

Abstract: Methods of reducing retrograde fluid flow through a valve within a body vessel are provided. The methods can include the steps of identifying a valve exhibiting an undesirable amount of retrograde fluid flow within a body vessel, such as a venous valve or a heart valve, and providing a means for reducing the retrograde fluid flow. A medical device providing a desired amount of retrograde fluid flow can be modified after permitting the medical device to remain in a body cavity for a remodeling-effective time period. The implanted medical device can be modified by subsequently reducing the amount of retrograde fluid flow permitted across the implanted prosthetic valve within the body vessel.

Abstract: The disclosure relates to medical devices for implantation in a body vessel, and methods of using and making the same. A medical device can include a frame with one or more projections each having at least one edge extending from the surface of the frame, and a biocompatible, water-soluble removable material coated over at least a portion of the at least one edge. The projections can be barbs positioned to engage the interior wall of a body vessel or to attach a material, such as a valve leaflet or graft, to the frame. The removable material can be dissolved within a body vessel upon implantation, thereby exposing the at least one edge. Methods of making an implantable medical device and methods of treating a subject are also disclosed.

Abstract: Medical devices for implantation in a body vessel, and methods of using and making the same, are provided. Embodiments of the invention relate to medical devices comprising a frame having a compliance that can change upon implantation of the medical device within the lumen of a body vessel. Controlled fracture or bioabsorption of frame material can, in some embodiments, increase the compliance of a frame after implantation. Medical devices comprising a frame and one or more valve members adapted to regulate fluid flow in a body vessel, such as a vein, are also provided.

Abstract: A medical prosthesis for implantation within the body of a patient comprises a support structure and an anchoring element that comprises a basal portion and at least one barb extending from the basal portion. The anchoring element may be slidably attached to the strut and the strut may include a first stop and a second stop that define a longitudinal zone of movement for the anchoring element. Other devices and methods are described.

Abstract: Prosthetic valves for regulating fluid flow through a body vessel are described. The valves include a valve member that includes at least a portion that is capable of moving to selectively permit and substantially prevent fluid flow through the body vessel, either alone or with one or more additional valve members. A cannula is associated with the valve and permits a controlled amount of fluid flow through the valve, such as retrograde flow while the valve member substantially prevents fluid flow through the body vessel.

Abstract: Medical devices for implantation in a body vessel, and methods of using and making the same, are provided. A medical device can include a frame with one or more projections each having at least one edge extending from the surface of the frame, and a biocompatible, water-soluble removable material coated over at least a portion of the at least one edge. The projections can be barbs positioned to engage the interior wall of a body vessel or to attach a material, such as a valve leaflet or graft, to the frame. The removable material can be dissolved within a body vessel upon implantation, thereby exposing the at least one edge. Methods of making an implantable medical device and methods of treating a subject are also disclosed.

Abstract: Exchangeable delivery systems, methods of making delivery systems, and methods of delivering a self-expandable prosthetic device are provided. Delivery systems according to embodiments of the invention include an elongate tubular member defining a passageway with a distal end defining an exchange port, and a distal tip member disposed at least partially within the distal end of the passageway. A pusher is disposed in the passageway to effect axial movement of the distal tip member.

Abstract: The disclosure relates to a flow-deflecting medical device comprising a support structure and at least one flow-deflecting member attached to the support structure. The flow-deflecting member is at least partially evertible between a first position and a second position. In the first position, antegrade flow contacts the antegrade surface of the flow-deflecting member, urging the flow-deflecting member proximally in the body vessel such that antegrade flow is substantially uninterrupted. In the second position, retrograde flow contacts the retrograde surface of the flow-deflecting member, urging the flow-deflecting member distally in the body vessel, such that retrograde flow is received and redirecting by the flow-deflecting member. Also provided is a method for treating a body vessel valve-related condition comprising implanting a flow-deflecting medical device proximal to a native valve.

Abstract: Exchangeable delivery systems, methods of making delivery systems, and methods of delivering a self-expandable prosthetic device are provided. Delivery systems according to embodiments of the invention include an elongate tubular member defining a passageway with a distal end defining an exchange port, and a distal tip member slideably disposed partially within the distal end of the passageway.

Abstract: Described, in certain aspects, are devices and methods for treating fistulae. In one embodiment, a fistula plug includes a hydratable component and hydration resistant component incorporated on or in the hydratable component. Illustratively, an inventive plug can include a first component and a second component, wherein the first component is hydratable, and the second component is less receptive to hydration than the first component (or is essentially non-hydratable). Either of these components may be formed with one or more of a variety of biocompatible materials including some that are naturally derived and some that are non-naturally derived. In one embodiment, the first component and the second component, while dissimilar in their receptivity to hydration, are both comprised of a remodelable, angiogenic material, for example, a remodelable extracellular matrix material such as submucosa.

Abstract: Described are methods and apparatuses for delivering fistula plugs into fistulae having at least a primary fistula opening, a secondary fistula opening, and a fistula tract extending therebetween. Illustratively, some inventive methods involve delivering a fistula plug into a fistula tract through a primary fistula opening and toward a secondary fistula opening, while others involve delivering a fistula plug into a fistula tract through a secondary fistula opening and toward a primary fistula opening. In certain aspects, a fistula plug is pushed and/or pulled through a fistula tract along a guidewire or other plug-guiding device, potentially protected by a protective delivery device such as a sheath, capsule or other suitable delivery vehicle.

Abstract: The present invention provides, in certain aspects, medical devices deliverable into passageways and other open spaces in the body. In one embodiment, the invention provides a fistula plug for delivery into a fistula tract. This fistula plug comprises an elongate plug body, and a removable core material that is received in the plug body and effective to increase the column strength of the plug body. The plug body may be formed with one or more of a variety of biocompatible materials including some that are naturally derived and some that are non-naturally derived. The present invention also provides apparatuses and methods for delivering these and other medical devices into the body. One such apparatus comprises a fistula plug having a plug body, and a removable delivery device received in the plug body, wherein the delivery device is effective to deliver the plug body into a fistula tract when advanced therethrough.

Abstract: The invention relates to a prosthetic valve for regulating flow through a body lumen. The medical device comprises discrete shaping members, a flexible covering, and a valve member. The discrete shaping members are operatively attached to the flexible covering, such that the medical device may exhibit low radial force and dynamic movement.

Abstract: A delivery system and method for introducing a self-expanding prosthesis into a work site of a patient. The delivery system is introduced to the work site over an elongate guiding member. The delivery system is subsequently uncoupled from the guiding member upon deployment of the prosthesis while remaining within the work site. In an exemplary embodiment of the invention, the delivery system comprises an elongate outer member slidably disposed about an elongate inner member. A self-expanding prosthesis is disposed within the outer member and is laterally constrained thereby in a compressed delivery configuration, and is constrained against longitudinal movement relative to the inner member. The inner member further comprises a passageway extending through the distal portion thereof the passageway extending between a distal opening near the distal end of the inner member and a proximal opening spaced proximally from the distal end of the inner member.

Abstract: A wire guide and a medical system including an elongate member having a releasably connected loop are provided. The wire guide includes an elongate shaft having a proximal portion and a distal portion. The distal portion of the shaft includes a loop releasably connected to the shaft in a first looped configuration. The loop is disconnectable at a detachment point and forms a second configuration wherein the loop is at least partially disconnected from the shaft. A method of making the wire guide and a method of disconnecting a loop portion of a medical device are also provided.