The invention relates to a device for use in the transcatheter treatment of mitral valve regurgitation, specifically a coaptation assistance element for implantation across the valve; a system including the coaptation assistance element and anchors for implantation; a system including the coaptation assistance element and delivery catheter; and a method for transcatheter implantation of a coaptation element across a heart valve.

Systems for mitral valve repair are disclosed where one or more mitral valve interventional devices may be advanced intravascularly into the heart of a patient and deployed upon or along the mitral valve to stabilize the valve leaflets. The interventional device may also facilitate the placement or anchoring of a prosthetic mitral valve implant. The interventional device may generally comprise a distal set of arms pivotably and/or rotating coupled to a proximal set of arms which are also pivotably and/or rotating coupled. The distal set of arms may be advanced past the catheter opening to a subannular position (e.g., below the mitral valve) and reconfigured from a low-profile delivery configuration to a deployed securement configuration. The proximal arm members may then be deployed such that the distal and proximal arm members may grip the leaflets between the two sets of arms to stabilize the leaflets.

Features for a restraint to facilitate delivery and deployment of an implantable cardiac device are described. The restraint may include a series of circumferential engagements for securing inwardly corresponding portions of the implant. The restraint may be located inside the implant and provide a radially inward force on the implant. The restraint may include a center shaft having a series of grooves configured to cooperate with corresponding splines of the implant. Distal or proximal advance of the restraint disengages the restraint from the implant. The implant may include a tubular frame configured to contract and be secured by the restraint in a contracted configuration and to expand upon disengagement from the restraint. The restraint may provide for a smaller overall cross-sectional profile of a transcatheter delivery system, for instance by negating the need for a distal delivery sheath.

A method for transcatheter delivery to a native heart valve needing replacement. A first component is attached to the native annulus upstream of the native leaflets maintaining native leaflet function, and is held to the native annulus by barbs that are activated by a torus balloon after the first component is fully expanded. The torus balloon can be implanted along with the support frame. A limiting cable restricts further expansion of the first component and holds a second component that contains the replacement leaflets.

A method of making an annuloplasty implant includes forming first and second support rings arranged in a coiled configuration around an axial direction and forming at least part of the first and second support ring from a carbon fiber material. The first and second support rings can be formed by 3-D printing according to dimensions of a 3-D reconstruction of a heart valve.

Systems, devices and methods for resizing a valve annulus are described. An implant is delivered proximate a mitral valve, the implant comprising a tubular body and a plurality of piercing helical anchors, the tubular body comprising an proximal diameter and a distal diameter. Tissue proximate the mitral valve is engaged by rotating the plurality of anchors with corresponding rotational drivers. The tubular body may be transitioned from a first structural configuration having the proximal diameter smaller than the distal diameter to a second structural configuration having the proximal diameter larger than the distal diameter.

A two-part aortic annular support system for supporting an aortic annulus during aortic valve repair procedures for prevention of further annular dilation. The first part comprises a composite annular ring that is positionable from within an aortic valve into the left ventricular outflow tract at the level of annular plane. The composite ring comprises a semi-rigid section and a resiliently deformable section. The semi-rigid section is shorter in length than the deformable section. The deformable section is extendible into a commissure of the aortic valve. The second part is a resilient band that is positionable external to the aortic root. The resilient band is securable to the composite ring through the aortic annulus by suturing. The present disclosure also relates to a use of the aortic annular support system and a method of inserting and securing the aortic annular support system during a surgical intervention.

Coating of at least a portion of components of an implantable device to reduce friction during movement therebetween. The surfaces of the components which are coated may be pretreated in a manner contrary to recommended for application of such coating or may simply not be treated as recommend for application of such coating.

Systems, devices, and methods for adjusting cardiac tissue are described involving adjustment of a frame element of an implantable device relative to the cardiac tissue. At least a component of the implantable device is rotated relative to the cardiac tissue and/or another component of the implantable device. At least a component of the implantable device is axially movable relative to the cardiac tissue and/or another component of the implantable device.

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.