Abstract: Disclosed herein are steerable catheter assemblies and methods of steering catheters. Some embodiments include a catheter with first and second oppositely disposed pull wires and third and fourth oppositely disposed pull wires that flex the catheter, a control handle coupled to the catheter, a first follower connected to the first pull wire, a second follower connected to the second pull wire, a first driver coupled to the control handle and coupled to the first and second followers, a third follower connected to the third pull wire, a fourth follower connected to the fourth pull wire, and a second driver coupled to the control handle and coupled to the third and fourth followers. Rotation of the first driver moves the first and second followers in opposite directions. Rotation of the second driver moves the third and fourth followers in opposite directions.

Abstract: One method of implanting a prosthetic valve includes advancing the valve into a patient with a delivery apparatus. The valve includes apices circumferentially-spaced apart relative to each other. At least some of the apices include first apertures. The delivery apparatus includes release arms and a sheath. The release arms include second apertures for receiving the apices. At least one of the second apertures of the release arms has a different length than another one of the second apertures. The method also includes positioning the valve at a location, retracting a sheath of the delivery apparatus relative to the valve, allowing the valve to self-expand from a radially compressed state to a radially expanded state, and while the valve is coupled to the delivery apparatus, pivoting the valve relative about the release arms such that an axis of the valve is tilted relative to an axis of the delivery apparatus.

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: 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 exemplary 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 includes a pair of gripping members that are configured to attach to the native valve of the patient. A gripper control mechanism is configured to independently engage and move each of the gripping members.

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: A system for implanting a repair device onto a native valve of a natural heart to repairing the native valve of a patient during a non-open-heart procedure. The system includes a paddle and a gripping member. The paddle is movable between an open position and a closed position. The gripping member has a weakened portion and a barbed portion. The barbed portion is configured to secure the gripping member to valve tissue of the native valve of the patient. A gripper control mechanism is configured to move the gripping member between an open position and a closed position. The gripper control mechanism comprises a suture removably attached to the gripping member at a first connection point and a pushing member configured to engage the gripping member at a second connection point. The weakened portion is between the first and second connection points.

Abstract: An exemplary valve repair device for repairing a native valve of a patient has a pair of paddles, a pair of gripping members, and at least one latch member. The paddles are movable between an open position and a closed position. The paddles and/or the gripping members are configured to attach to the native valve of the patient. When the paddles are in the closed position, the latch members latch the paddles in the closed position.

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 base assembly, a pair of paddles, and a pair of gripping members. The base assembly includes a shaft and a coupler attached to the shaft such that the coupler can be moved along the shaft. The paddles are movable between an open position, a closed position and a bailout position. The paddles and the gripping members are configured to attach to the native valve of the patient. Movement of the coupler along the shaft causes the paddles to move between the open position, the closed position, and the bailout position. When the paddles are in the bailout position, a bailout angle between each paddle of the pair of paddles and the shaft is greater than or equal to 120 degrees.

Abstract: A pair of paddles are moved laterally away from one another in an exemplary method of repairing a native valve of a patient during a non-open-heart procedure. After the paddles are moved laterally away from one another, first and second gripping members are moved from an open position to a closed position to grasp valve leaflets. The paddles are then moved laterally toward one another. A cam can be used to move the paddles away from one another.

Abstract: An implantable prosthetic device can include a spacer member, a plurality of anchors, and a plurality of clasps. The spacer member can be configured to be disposed between native leaflets of a heart. The anchors can be coupled to the spacer member and configured to secure the native leaflets against the spacer member. The clasps can be coupled to a respective anchor and configured to secure the native leaflets to the anchors. The clasps can be independently movable between an open configuration and a closed configuration.

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 base assembly having a plurality of pivoting links, a pair of paddles attached to the base assembly, a pair of gripping members attached to the base assembly, and at least one coaptation or spacer element disposed between the pair of gripping members. Movement of the pivoting links of the base assembly causes the paddles to move between an open position and a closed position. The paddles and the gripping members are configured to attach to valve leaflets of the patient. The coaptation or spacer element is configured to fill at least a portion of a gap between the valve leaflets of the patient.

Abstract: An exemplary 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 delivery device includes a catheter, an actuation shaft, and a coupler. The valve repair device is configured to be delivered through the catheter. The valve repair device is configured to attach to a native valve of a patient. The valve repair device includes a coaption element having a first end portion and a second end portion, a proximal collar attached to the first end portion of the coaption element, first and second paddles connected to the coaption element, and a distal collar connected to the first and second paddles. The coupler is releasably connected to the proximal collar. The actuation shaft extends through the coupler, the proximal collar, and the coaption element. The actuation shaft is releasably connected to the distal collar.

Abstract: A system for implanting a repair device onto a native valve of a natural heart to repairing the native valve of a patient during a non-open-heart procedure. The system includes a surgical delivery instrument, a valve repair device, and a gripper control mechanism. The surgical delivery instrument has at least one lumen. The valve repair device is configured to be delivered through the lumen of the surgical delivery instrument and to be attached to a native valve of a patient. The valve repair device has a pair of paddles, and first and second gripping members. The paddles are movable between an open position and a closed position. The paddles and the first and second gripping members are configured to attach to the native valve of the patient. The gripper control mechanisms each include a suture and a wire having a loop at a distal end. The suture extends from the surgical delivery instrument and through the loop of the wire. The suture is removably attached to the gripping member.

Abstract: An exemplary recapturable valve repair system for repairing a native valve of a patient during a non-open heart procedure has a delivery device, a valve repair device, and a tethering line. The delivery device has a catheter and a coupler. The valve repair device is configured to be delivered through the catheter and attach to a native valve of a patient. The valve repair device includes a coaption element, a proximal collar, and first and second paddles. The first and second paddles are connected to the coaption element. The coupler is releasably connected to the proximal collar. The tethering line connects the valve repair device to the delivery device for recapturing the valve repair device.

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 pair of paddles and a pair of gripping members. The paddles are movable between an open position and a closed position. The paddles and the gripping members are configured to attach to the native valve of the patient. The paddles are biased to the closed position, latched to the gripping members in the closed position, maintained in the closed position by a threaded connection, or otherwise maintained in the closed position.

Abstract: A system for implanting a repair device onto a native valve of a natural heart to repairing the native valve of a patient during a non-open-heart procedure. The system includes a pair of paddles and a pair of gripping members. The paddles are moveable between an open position and a closed position. The gripping members can have different configurations for effective attachment and release from the native valve of the patient.

Abstract: An exemplary valve repair device for repairing a valve of a patient has a paddle, and a clasp. The clasp has a fixed arm attached to the paddle and a moveable arm. The moveable arm includes barbs that are spaced apart from a connection between the moveable arm and the fixed arm. The moveable arm is movable between open and closed positions relative to the fixed arm. The moveable arm has a weakened portion between the barbs and the connection between the moveable arm and the fixed arm. Applying tension to the movable arm in a retraction direction stretches the moveable arm and moves the barbs in the retraction direction.

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 catheters include cam and follower mechanisms that provide independent control of catheter flex magnitude and catheter flex direction to provide improved steerability of an attached catheter. In certain embodiments, the steerable catheter assemblies include two or more pull wires that flex the catheter, and a control handle coupled to the catheter having a direction control and a magnitude control, both of which are operably coupled to the two or more pull wires by the cam and follower mechanism. In embodiments disclosed herein, the cam and follower system can be modified to achieve particular catheter control.