Abstract: Delivery systems for expandable and stented implants include adjustable tensioning members that control the expansion of the implant along the length of the implant. The tensioning members are wound onto one or more rotors located on the distal segment of the delivery system, which are rotated to unwind the tensioning members and incrementally expand the implant. Positioning mechanisms are also provided to adjust the position and orientation of the implant during delivery.

Abstract: Delivery systems for expandable and stented implants include adjustable tensioning members that control the expansion of the implant along the length of the implant. The tensioning members are wound onto one or more rotors located on the distal segment of the delivery system, which are rotated to unwind the tensioning members and incrementally expand the implant. Positioning mechanisms are also provided to adjust the position and orientation of the implant during delivery.

Abstract: A delivery device for cardiac valve repair implants includes a delivery catheter and an extension member protruding from a distal end of the delivery catheter. The delivery device further includes a control arm assembly having pairs of control arms. Each pair includes a proximal control arm drivable from a handle assembly of the delivery device and a distal arm coupled to a distal end of the proximal control arm and a distal end of the extension member. Proximally driving each of the proximal control arms of the control arm assembly results in expansion of the control arm assembly and corresponding expansion of a cardiac valve repair implant coupled to the control arm assembly.

Abstract: Delivery systems for expandable and stented implants include adjustable tensioning members that control the expansion of the implant along the length of the implant. The tensioning members are wound onto one or more rotors located on the distal segment of the delivery system, which are rotated to unwind the tensioning members and incrementally expand the implant. Positioning mechanisms are also provided to adjust the position and orientation of the implant during delivery.

Abstract: A delivery device for cardiac valve repair implants includes a delivery catheter and an extension member protruding from a distal end of the delivery catheter. The delivery device further includes a control arm assembly having pairs of control arms. Each pair includes a proximal control arm drivable from a handle assembly of the delivery device and a distal arm coupled to a distal end of the proximal control arm and a distal end of the extension member. Proximally driving each of the proximal control arms of the control arm assembly results in expansion of the control arm assembly and corresponding expansion of a cardiac valve repair implant coupled to the control arm assembly.

Abstract: A replacement heart valve comprises a unibody, folded, double-wall stent, with a stent cover and a leaflet valve attached to the inner lumen of the stent. The heart valve is delivered using a multi-pulley, suture-based stent restraint assembly provided by fixed guide openings or structures along the distal end of the delivery system that independently permits expansion of the distal and proximal ends of the outer wall of the stent, and control of the inner wall expansion simultaneously with or separately from the expansion of the outer wall.

Abstract: A replacement heart valve comprises one or more stent frame features, including inset barbs, ring attachment structures or attachment tabs.

Abstract: A replacement heart valve comprises a unibody, folded, double-wall stent, with a stent cover and a leaflet valve attached to the inner lumen of the stent. The heart valve is delivered using a multi-pulley, suture-based stent restraint assembly provided by fixed guide openings or structures along the distal end of the delivery system that independently permits expansion of the distal and proximal ends of the outer wall of the stent, and control of the inner wall expansion simultaneously with or separately from the expansion of the outer wall.

Abstract: Delivery systems for expandable and stented implants include adjustable tensioning members that control the expansion of the implant along the length of the implant. The tensioning members are wound onto one or more rotors located on the distal segment of the delivery system, which are rotated to unwind the tensioning members and incrementally expand the implant. Positioning mechanisms are also provided to adjust the position and orientation of the implant during delivery.

Abstract: A valve implant includes an occlusive assembly and a frame coupled to the occlusive assembly. The frame transitions from a collapsed state to an expanded state about a central longitudinal axis and transitioning from the collapsed state to the expanded state causes a proximal end of the frame to expand radially outward from the central longitudinal axis. The valve implant further includes an outer sheet supported on a proximal portion of the frame. The occlusive assembly is supported on a distal portion of the frame such that the inner sheet extends about the central longitudinal axis and an annular opening is defined between the outer sheet and the inner sheet when the frame is in the expanded state.

Abstract: A cardiac valve repair implant, wherein the implant includes a central occluder, and frame and a thin sheet. The central occluder includes a central longitudinal axis. The frame extends proximally from the central occluder and is centered about and forms a circumference around the central longitudinal axis of the central occluder. The frame self-biases from a collapsed state to an expanded state. A proximal end of the frame projects proximally when the frame is in the collapsed state. The proximal end of the frame projects radially outward away from the central longitudinal axis of the central occluder when the frame is in the expanded state. The thin sheet is supported on a proximal portion of the frame. When the frame is in the expanded state, the thin sheet forms an annular surface defining an inner circular opening centered about the central longitudinal axis of the central occluder.

Abstract: Delivery systems for expandable and stented implants include adjustable tensioning members that control the expansion of the implant along the length of the implant. The tensioning members are wound onto one or more rotors located on the distal segment of the delivery system, which are rotated to unwind the tensioning members and incrementally expand the implant. Positioning mechanisms are also provided to adjust the position and orientation of the implant during delivery.

Abstract: A replacement heart valve comprises a unibody, folded, double-wall stent, with a stent cover and a leaflet valve attached to the inner lumen of the stent. The heart valve is delivered using a multi-pulley, suture-based stent restraint assembly provided by fixed guide openings or structures along the distal end of the delivery system that independently permits expansion of the distal and proximal ends of the outer wall of the stent, and control of the inner wall expansion simultaneously with or separately from the expansion of the outer wall.

Abstract: An apparatus for replacement a native heart valve is herein provided. The apparatus includes a replacement heart valve, an expandable anchor, and a plurality of rivets. The expandable anchor comprises a woven braid structure that surrounds at least a portion of the replacement heart valve and has a plurality of braid intersections. At least some of the braid intersections have rivets extending therethrough.

Abstract: The disclosure pertains to profile reduction seals associated with heart valve replacements which may reduce or eliminate paravalvular regurgitation and methods of fabricating such seals. The generally cylindrical multilayer seals of the disclosure include a crown-like end and reinforcing elements which facilitate compression of the seal and associated device by minimizing bunching of the seal as it enters a delivery system.

Abstract: A tissue modification apparatus includes a first and a second guide, a first and a second set of mounts, and a first and a second actuator. The first guide defines a first axis, and the second guide defines a second axis intersecting the first axis. The mounts of the first set of mounts are movable relative to one another along the first axis, and the mounts of the second set of mounts are movable relative to one another along the second axis. The first actuator and the second actuator are each settable to a stress load, with the first actuator and the second actuator movable, respectively, along the first axis and the second axis to transmit each respective stress load to a piece of tissue mechanically coupled to the first and second set of mounts.

Abstract: An apparatus for replacement a native heart valve is herein provided. The apparatus includes a replacement heart valve, an expandable anchor, and a plurality of rivets. The expandable anchor comprises a woven braid structure that surrounds at least a portion of the replacement heart valve and has a plurality of braid intersections. At least some of the braid intersections have rivets extending therethrough.

Abstract: An apparatus for endovascularly replacing a patient's heart valve comprises an anchor having an outer surface and an inner surface. The anchor is expandable from a collapsed delivery configuration to a fully deployed configuration. A first locking element and a second locking element are attached to the inner surface of the anchor. The first locking element is engageable with the second locking element. At least one of the first locking element and the second locking element has a curved outer surface. Methods for attaching the second locking element to the anchor are also provided.

Abstract: A tissue modification apparatus includes a first and a second guide, a first and a second set of mounts, and a first and a second actuator. The first guide defines a first axis, and the second guide defines a second axis intersecting the first axis. The mounts of the first set of mounts are movable relative to one another along the first axis, and the mounts of the second set of mounts are movable relative to one another along the second axis. The first actuator and the second actuator are each settable to a stress load, with the first actuator and the second actuator movable, respectively, along the first axis and the second axis to transmit each respective stress load to a piece of tissue mechanically coupled to the first and second set of mounts.

Abstract: A tissue modification apparatus includes a first and a second guide, a first and a second set of mounts, and a first and a second actuator. The first guide defines a first axis, and the second guide defines a second axis intersecting the first axis. The mounts of the first set of mounts are movable relative to one another along the first axis, and the mounts of the second set of mounts are movable relative to one another along the second axis. The first actuator and the second actuator are each settable to a stress load, with the first actuator and the second actuator movable, respectively, along the first axis and the second axis to transmit each respective stress load to a piece of tissue mechanically coupled to the first and second set of mounts.