Abstract: A delivery system for delivery of a radially expandable device to an implantation site in a patient, the delivery system including an elongated tubular member comprising a distal tip and an outer surface, first and second balloon portions spaced proximally from each other and the distal tip along a length of the tubular member, an annular space between the first and second balloon portions, a plurality of clip deployment tubes extendably moveable relative to the outer surface of the tubular member, and a plurality of clips, wherein each clip is moveable within a length of one of the clip deployment tubes between a retracted position and a deployed position.

Abstract: A stented valve having at least one leaflet made of pericardium or other material having a relatively thin profile at the annulus. The leaflets are attached via chords to a stent frame, where the chords are positioned to mimic the native valve anatomy and functionality. In particular, the valves of one exemplary embodiment of the invention are sized to replace a mitral valve and therefore the chords are arranged to prevent prolapse of the leaflets into the atrium. The stented valve has a relatively short height at its annulus due to the positioning of the chords. In addition, the stented valve is capable of being crimped to a small enough size that it can be delivered to the implantation site via transcatheter delivery systems and methods.

Abstract: Aspects of the disclosure relate to devices and methods for preparing an existing, implanted prosthetic aortic valve for subsequent prosthetic aortic valve implantation. To prepare the existing valve, a valve preparation device is delivered to the valve and valve leaflets are severed either via mechanical cutting or electrodes so that the leaflets cannot obstruct a blood flow path once a prosthetic valve is subsequently implanted within the valve. Similarly, in alternate embodiments, devices and methods of the disclosure can be used for preparing a native aortic valve for delivery and implantation of a prosthetic valve.

Abstract: A prolapse prevention device formed by a continuous wire-like structure having a first end and a second end disconnected from each other. The continuous wire-like structure of the prolapse prevention device is substantially straight in a delivery configuration. The prolapse prevention device in a deployed configuration includes a centering ring of the continuous wire-like structure configured to seat adjacent to and upstream of an annulus of a heart valve in situ, a vertical support of the continuous wire-like structure which extends from the centering ring and includes an apex configured to seat against a roof of an atrium in situ, and a leaflet backstop of the continuous wire-like structure extending radially inward from the centering ring and configured to contact at least at least a first leaflet of the heart valve in situ to exert a pressure in a downstream direction on the first leaflet to prevent the first leaflet from prolapsing into the atrium.

Abstract: Devices, systems, and methods for crimping a medical device are disclosed. More specifically, the present disclosure relates to devices, systems, and methods for reducing the diameter of a collapsible heart valve prosthesis to be loaded onto a delivery device. The devices, systems, and methods using at least one funnel to crimp the heart valve prosthesis and load it onto the delivery system.

Abstract: Devices, systems, and methods for crimping a medical device are disclosed. More specifically, the present disclosure relates to devices, systems, and methods for reducing the diameter of a collapsible heart valve prosthesis to be loaded onto a delivery device. The devices, systems, and methods using at least one funnel to crimp the heart valve prosthesis and load it onto the delivery system.

Abstract: Systems and methods for modifying a heart valve annulus in a minimally invasive surgical procedure. A helical anchor is provided, having a memory set to a coiled shape or state. The helical anchor is further configured to self-revert from a substantially straight state to the coiled state. The helical anchor is loaded within a needle that constrains the helical anchor to the substantially straight state. The needle is delivered to the valve annulus and inserted into tissue of the annulus. The helical anchor is then deployed from the needle (e.g., the needle is retracted from over the helical anchor). Once deployed, the helical anchor self-transitions toward the coiled shape, cinching engaged tissue of the valve annulus.

Abstract: Systems and methods for approximating tissue segments, such as mitral valve leaflets, on a minimally invasive basis. The system includes first and second approximation devices each including a magnetic component and an attachment mechanism. Each device is connected to a target tissue segment by the corresponding attachment mechanism. Upon deployment at a target site, the tissue approximation devices are magnetically attracted to one another, approximating the tissue segments and maintaining the tissue segments in the approximated state.

Abstract: Systems and methods for modifying a heart valve annulus in a minimally invasive surgical procedure. A helical anchor is provided, having a memory set to a coiled shape or state. The helical anchor is further configured to self-revert from a substantially straight state to the coiled state. The helical anchor is loaded within a needle that constrains the helical anchor to the substantially straight state. The needle is delivered to the valve annulus and inserted into tissue of the annulus. The helical anchor is then deployed from the needle (e.g., the needle is retracted from over the helical anchor). Once deployed, the helical anchor self-transitions toward the coiled shape, cinching engaged tissue of the valve annulus.

Abstract: Stented prosthetic heart valves including a stent frame having a plurality of stent frame support structures collectively defining an interior surface, an exterior surface and a plurality of cells. The stented prosthetic heart valve further including a valve structure including valve leaflets disposed within and secured to the stent frame and defining a margin of attachment. The stented prosthetic heart valve including one or both of an outer paravalvular leakage prevention wrap and an inner skirt for supporting the valve leaflets. In various embodiments, the outer wrap is positioned entirely on one side of the margin of attachment. In embodiments including an inner skirt, the outer wrap and the inner skirt are on opposite sides of the margin of attachment such that the inner skirt and the outer wrap do not overlap. In other embodiments, the outer wrap includes a plurality of zones having varying thickness.

Abstract: A stented valve having at least one leaflet made of pericardium or other material having a relatively thin profile at the annulus. The leaflets are attached via chords to a stent frame, where the chords are positioned to mimic the native valve anatomy and functionality. In particular, the valves of one exemplary embodiment of the invention are sized to replace a mitral valve and therefore the chords are arranged to prevent prolapse of the leaflets into the atrium. The stented valve has a relatively short height at its annulus due to the positioning of the chords. In addition, the stented valve is capable of being crimped to a small enough size that it can be delivered to the implantation site via transcatheter delivery systems and methods.

Abstract: A stented valve having at least one leaflet made of pericardium or other material having a relatively thin profile at the annulus. The leaflets are attached via chords to a stent frame, where the chords are positioned to mimic the native valve anatomy and functionality. In particular, the valves of one exemplary embodiment of the invention are sized to replace a mitral valve and therefore the chords are arranged to prevent prolapse of the leaflets into the atrium. The stented valve has a relatively short height at its annulus due to the positioning of the chords. In addition, the stented valve is capable of being crimped to a small enough size that it can be delivered to the implantation site via transcatheter delivery systems and methods.

Abstract: A delivery system for delivery of a radially expandable device to an implantation site in a patient, the delivery system including an elongated tubular member comprising a distal tip and an outer surface, first and second balloon portions spaced proximally from each other and the distal tip along a length of the tubular member, an annular space between the first and second balloon portions, a plurality of clip deployment tubes extendably moveable relative to the outer surface of the tubular member, and a plurality of clips, wherein each clip is moveable within a length of one of the clip deployment tubes between a retracted position and a deployed position.

Abstract: A delivery system for delivery of a radially expandable device to an implantation site in a patient, the delivery system including an elongated tubular member comprising a distal tip and an outer surface, first and second balloon portions spaced proximally from each other and the distal tip along a length of the tubular member, an annular space between the first and second balloon portions, a plurality of clip deployment tubes extendably moveable relative to the outer surface of the tubular member, and a plurality of clips, wherein each clip is moveable within a length of one of the clip deployment tubes between a retracted position and a deployed position.

Abstract: Systems and methods for approximating tissue segments, such as mitral valve leaflets, on a minimally invasive basis. The system includes first and second approximation devices each including a magnetic component and an attachment mechanism. Each device is connected to a target tissue segment by the corresponding attachment mechanism. Upon deployment at a target site, the tissue approximation devices are magnetically attracted to one another, approximating the tissue segments and maintaining the tissue segments in the approximated state.

Abstract: A valve prosthesis includes one or more anti-paravalvular leakage components coupled to a stent. The anti-paravalvular leakage component may encircle the stent and include a radially expandable control ring coupled to an unattached edge of a flexible skirt which extends the unattached skirt edge outwardly away from the stent and against the native heart valve to form an open-ended annular pocket around the stent. The anti-paravalvular leakage component may encircle the perimeter of the stent and include a flexible skirt having opposing edges coupled to the stent to form one or more enclosed compartments around the stent. Each compartment includes a one-way valve which allows for blood flow into the compartment but prevents blood flow out of the compartment. The anti-paravalvular leakage component may be at least one flap that is coupled to an inner surface of the stent and formed of a flexible material moveable by blood flow.

Abstract: Systems and methods for modifying a heart valve annulus in a minimally invasive surgical procedure. A helical anchor is provided, having a memory set to a coiled shape or state. The helical anchor is further configured to self-revert from a substantially straight state to the coiled state. The helical anchor is loaded within a needle that constrains the helical anchor to the substantially straight state. The needle is delivered to the valve annulus and inserted into tissue of the annulus. The helical anchor is then deployed from the needle (e.g., the needle is retracted from over the helical anchor). Once deployed, the helical anchor self-transitions toward the coiled shape, cinching engaged tissue of the valve annulus.

Abstract: Devices, systems, and methods for crimping a medical device are disclosed. More specifically, the present disclosure relates to devices, systems, and methods for reducing the diameter of a collapsible heart valve prosthesis to be loaded onto a delivery device. The devices, systems, and methods using at least one funnel to crimp the heart valve prosthesis and load it onto the delivery system.

Abstract: A valve prosthesis includes one or more anti-paravalvular leakage components coupled to a stent. The anti-paravalvular leakage component may encircle the stent and include a radially expandable control ring coupled to an unattached edge of a flexible skirt which extends the unattached skirt edge outwardly away from the stent and against the native heart valve to form an open-ended annular pocket around the stent. The anti-paravalvular leakage component may encircle the perimeter of the stent and include a flexible skirt having opposing edges coupled to the stent to form one or more enclosed compartments around the stent. Each compartment includes a one-way valve which allows for blood flow into the compartment but prevents blood flow out of the compartment. The anti-paravalvular leakage component may be at least one flap that is coupled to an inner surface of the stent and formed of a flexible material moveable by blood flow.

Abstract: A delivery system for delivery of a radially expandable device to an implantation site in a patient, the delivery system including an elongated tubular member comprising a distal tip and an outer surface, first and second balloon portions spaced proximally from each other and the distal tip along a length of the tubular member, an annular space between the first and second balloon portions, a plurality of clip deployment tubes extendably moveable relative to the outer surface of the tubular member, and a plurality of clips, wherein each clip is moveable within a length of one of the clip deployment tubes between a retracted position and a deployed position.