Abstract: A loader and method for loading a transcatheter heart valve into a delivery sheath or catheter is described that is also configured to facilitate retrieval of the heart valve back through the delivery sheath while protecting the delivery sheath from damage. Another loader provides for easier crimping and loading of a THV into a delivery sheath or catheter from a storage jar or container. A method for crimping a THV facilitates easier end user preparation of the valve for implantation and reduces the likelihood of tissue deformation in the valve during storage. These devices and methods for deploying THVs simplify the valve replacement procedure.

Abstract: Disclosed herein are catheter control handles that include various mechanisms for controlling the circumferential angle and radial magnitude of flexion of an attached catheter. Control handles can comprise a housing. Control wires extend from a distal end of the housing and into a steerable transluminal device. A flex control member is operable to control tension on the pull wires to adjust a magnitude of radial flexion of the steerable transluminal device. A position control member is operable to control tension on the pull wires to adjust a circumferential angle in which the radial flexion of the steerable transluminal device is directed.

Abstract: Steerable catheter control handles and catheter assemblies that include pull wires and direction and magnitude controls on the handle operable such that adjustment of the direction and magnitude controls adjusts a direction and degree of catheter flex, thereby to steer the catheter as an operator directs.

Abstract: A method for retrieving a previously inserted prosthetic valve is disclosed. In one example, a loader assembly is inserted through a hub of a delivery sheath device. The delivery sheath device includes an expandable sheath that extends into a blood vessel of a patient. The loader assembly is advanced in a distal direction until a distal section of the loader assembly extends into the expandable sheath which is attached to a distal end of the hub. The distal section has a larger inner diameter than a middle tube section of the loader assembly. A delivery catheter is retracted to move a prosthetic valve attached thereto in a proximal direction until the prosthetic valve is received within the distal section. The loader assembly and the delivery catheter are removed from a proximal end of the hub while the prosthetic valve is retained within the distal section.

Abstract: A valve repair devices and systems for repairing a native valve of a patient include a spacer, a plurality of paddles, and a plurality of moveable clasp arms. The plurality of moveable clasp arms are disposed between the plurality of paddles and the spacer. The moveable clasp arms are configured to attach to leaflets of a heart valve.

Abstract: A valve repair system for repairing a native valve of a patient during a non-open-heart procedure includes a delivery device and a valve repair device. The valve repair device include a pair of paddles, first gripping member, a second gripping member, and a spacer. First and second gripping member controls or first and second gripping member control portions are coupled to the first and second gripping members to move the gripping members. The spacer element is configured to close a gap in the native valve of the patient when the valve repair device is attached to the native valve.

Abstract: A valve repair device for repairing a native valve of a patient. The valve repair device includes a compressible spacer element, a pair of paddles, and a pair of gripping members. The pair of paddles are coupled to the spacer element. The pair of gripping members are disposed between the pair of paddles. The paddles and the gripping members are configured to attach to leaflets of a heart valve.

Abstract: Components for valve treatment systems are disclosed. Valve treatment systems can include a delivery system for an implantable device. The delivery system can include one or more of clasp control components slidably disposed on a catheter handle, a control element for opening and closing the implantable device, a catheter assembly with features to reduce friction with another catheter assembly, grips for attaching catheter assemblies to clamps, catheter assemblies with features that stiffen or provide variable stiffness, and catheter assemblies with one or more steering control lumens incorporated into a reinforcement layer.

Abstract: In one example, an implantable prosthetic device comprises a spacer body portion configured to be disposed between native leaflets of a heart, and an anchor portion configured to secure the native leaflets against the spacer body portion. The prosthetic device can be movable between multiple configurations. A size of the spacer body is configured to be adjusted after the spacer body is placed between the native valve leaflets and the pair of anchors are placed against the ventricular surfaces of the native heart valve leaflets. A delivery apparatus can have a first shaft and a second shaft, wherein movement of the first shaft relative to the second shaft moves the anchor portion relative to the spacer body.

Abstract: A prosthetic implant delivery assembly includes a prosthetic implant and a catheter. The prosthetic implant includes a plurality of apices with apertures. Each apex of the plurality of apices is circumferentially-spaced apart relative to an adjacent apex. The catheter includes a plurality of arms and a plurality of locking elements. Each of the arms includes an opening configured to receive a respective apex of the prosthetic implant. Each of the locking elements is configured to extend through the aperture of a respective apex of the prosthetic implant. A length of at least one of the locking elements is different than a length of another locking element such that when the prosthetic implant is coupled to the catheter by the locking elements, a longitudinal axis of the prosthetic implant can be held at a tilted position relative to a longitudinal axis of the catheter.

Abstract: A valve repair device for repairing a native valve of a patient includes a spacer element, a pair of paddles, and a pair of gripping members. The pair of paddles is coupled to the spacer element. The pair of gripping members is disposed between the pair of paddles. The paddles and the gripping members are configured to attach to leaflets of a heart valve. The spacer element extends past side edges of the gripping members, extends past side edges of the paddles, or extends past the side edges of both the gripping members and the paddles.

Abstract: An implantable device includes a spacer member configured to be disposed between leaflets of a native heart valve that is located between a first chamber and a second chamber of the heart. The device further includes a plurality of anchor members coupled to the spacer member and configured to capture the leaflets such that the device is retained between the leaflets. The spacer member is configured to provide a flow path through the device between the first chamber and the second chamber when the leaflets are captured such that blood can flow regurgitatively from the second chamber to the first chamber through the spacer member.

Abstract: An implantable device or implant is configured to be positioned within a native heart valve to allow the native heart valve to form a more effective seal. In some implementations, the implantable device or implant, or one or more portions thereof, can be configured to expand and/or contract. For example, the implantable device or implant can narrow during delivery and expand on implantation on the native heart valve.

Abstract: In one representative embodiment, an implantable prosthetic device comprises a spacer body portion configured to be disposed between native leaflets of a heart, and an anchor portion configured to secure the native leaflets against the spacer body portion. The prosthetic device can be movable between multiple configurations. The spacer body can be made from braided, self-expandable metallic thread. A delivery apparatus can have a first shaft and a second shaft, wherein movement of the first shaft relative to the second shaft moves the anchor portion relative to the spacer body.

Abstract: An implantable prosthetic device includes a plurality of anchor members, a plurality of clasps, and a cover. The plurality of clasps are configured to capture the leaflets to secure the leaflets to the anchor members. The cover is disposed over the plurality of anchor members. The cover can also be disposed over the clasps and a spacer member. A portion of the cover can be covered by a coupler. One or more extensions of a coupling collar can extend through the cover.

Abstract: A valve repair device includes a first paddle, a second paddle, a spacer, a first gripping member, and a second gripping member. The first paddle and the second paddle are configured to move between a closed position and an open position. The spacer is disposed between the first paddle and the second paddle. The first gripping member is disposed between the first paddle and the spacer. The second gripping member is disposed between the second paddle and the spacer. The first paddle and the first gripping member are configured to capture a first native valve leaflet. The second paddle and the second gripping member are configured to capture a second native valve leaflet.

Abstract: A system for implanting a repair device onto a native valve of a natural heart to repair the native valve of a patient during a non-open-heart procedure. The system includes a delivery catheter and a valve repair device. The valve repair device is disposed inside the delivery catheter. The valve repair device includes a pair of paddles and a pair of gripping members. The pair of paddles are movable between an open position and a closed position. The pair of paddles and the pair of gripping members are configured to secure the valve repair device to leaflets of the native valve. The pair of paddles are compressed inside the delivery catheter. Each paddle of the pair of paddles is configured to expand upon exiting the delivery catheter to increase the surface area of each paddle.

Abstract: A delivery apparatus includes a steerable guide sheath. The steerable guide sheath has a steerable portion, a pull ring located in the distal portion, and a pull wire coupled at one end to the pull ring and coupled at the opposite end to a control handle. The pull wire extends longitudinally through a pull-wire conduit. The steerable guide sheath further includes a compression-resistance portion made of metal and located in the distal portion.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes a coaption element, a pair of paddles, and barb portions. The barb portions extend directly from at least one of the coaption element and the pair of paddles.

Abstract: An implant catheter has a highly flexible portion. The highly flexible portion includes a liner positioned adjacent to a catheter coil. Some implementations of the implant catheter include sections where a portion of the coil layer is free from all material of the outer jacket. In some implementations, a portion of a layer internal to the catheter is omitted. Some implementations include a coil formed form wire with a self-aligning cross-section.