Abstract: A transcatheter valve prosthesis is disclosed that has a compressed, delivery configuration and an expanded configuration for deployment within a native heart valve. The valve prosthesis includes a self-expanding frame and a prosthetic valve component. The self-expanding frame includes a valve receiving portion defining an opening therethrough and first and second anchors at opposing ends of the valve receiving portion. The valve receiving portion is substantially planar and the first and second anchors are oriented substantially perpendicular to the valve receiving portion when the valve prosthesis is in the expanded configuration. The prosthetic valve component is disposed within the opening of the valve receiving portion and secured thereto.

Abstract: A prosthetic heart valve including a stent frame and a valve structure. The valve structure is disposed within a lumen of the stent frame. The stent frame is configured to self-expand from a compressed condition for transluminal delivery. The stent frame has a lattice structure forming a tubular shape defining a circumference and a plurality of closed cells arranged to define a band exhibiting a variable radial stiffness. The prosthesis can be deployed such that the band applies a minimal force on to anatomical locations relating to the heart's conductive pathways. A region of the band otherwise having low radial stiffness is located at or over a conductive pathway upon final implant.

Abstract: A prosthetic heart valve including a stent frame and a valve structure. The valve structure is disposed within a lumen of the stent frame. The stent frame is configured to self-expand from a compressed condition for transluminal delivery. The stent frame has a lattice structure forming a tubular shape defining a circumference and a plurality of closed cells arranged to define a band exhibiting a variable radial stiffness. The prosthesis can be deployed such that the band applies a minimal force on to anatomical locations relating to the heart's conductive pathways. A region of the band otherwise having low radial stiffness is located at or over a conductive pathway upon final implant.

Abstract: Aspects of the present invention provide apparatuses and methods for closing an apical hole in a heart of a subject, including a hole-closure device that includes a tissue-attachment portion configured to attach to cardiac tissue around the apical hole, and a collapsible portion coupled to the tissue-attachment portion and configured to close the hole by collapsing inwardly inside the apical hole.

Abstract: A valve prosthesis and methods for implanting the prosthesis are provided. The prosthesis generally includes a self-expanding frame and two or more engagement arms. A valve prosthesis is sutured to the self-expanding frame. Each engagement arm corresponds to a native mitral valve leaflet. At least one engagement arm immobilizes the native leaflets, and holds the native leaflets close to the main frame. The prosthetic mitral valve frame also includes two or more anchor attachment points. Each anchor attachment point is attached to one or more anchors that help attach the valve prosthesis to the heart.

Abstract: A delivery system for deploying a medical device includes a first attachment member configured to selectively couple to and radially constrain a first end portion of the medical device. The delivery system also includes a second attachment member configured to selectively couple to and radially constrain a second end portion of the medical device. The first attachment member is configured to move relative to the second attachment member such that the first attachment member applies a first tensile force to the first end portion of a medical device in a first direction and the second attachment member applies a second tensile force to the second end portion of a medical device in a second direction substantially opposite from the first direction.

Abstract: Medical device delivery assemblies are disclosed. The assembly may include a catheter-based delivery system. The assembly may include a pacing element to pace a patient's heart before, during, or after a procedure. The pacing element may be a detachable, implanting pacing element. The pacing element may be an implantable pacemaker and the implantable pacemaker may be disposed on a catheter-based delivery system. The assembly may include a prosthetic heart valve with one or more pacing elements on it. The pacing element may include a pacing strip or strips. These strips may be conductive or insulative. These strips may prevent, treat, or correct abnormal electrical communication in a heart.

Abstract: Valve retainers and delivery systems with valve retainers are disclosed. In certain embodiments, a portion of the valve retainer can rotate about a central axis of the delivery system relative to a different portion of the valve retainer. In certain embodiments, a first portion of the valve retainer can include a plurality of first orientation markings. In certain embodiments, a second portion of the valve retainer can include a second orientation marking, which can be aligned with a first orientation marking on the first portion of the valve retainer.

Abstract: Valve introducer systems and methods for implanting heart valve prostheses are disclosed, where a valve introducer includes an adjustable deployment mechanism comprising a deployment element and an implantation depth controlling element having a distal end and an adjustable length. The valve introducer also includes a tubular member having a distal end, configured to deliver a heart valve prosthesis, and a length extending from a fixed reference point. The implantation depth controlling element can comprise an inner and an outer cylinder, such as where the outer cylinder has interior threads, and the inner cylinder has exterior threads. The adjustable deployment element can include a depth gauge, wherein the depth gauge indicates the length the tubular member extends beyond a fixed reference point. In certain embodiments, the adjustable deployment element can also be configured to be secured to a cannula.

Abstract: A machined or molded hinge design, for use with a delivery device, which allows for controlled deflection of a large diameter catheter. With embodiments in which the delivery device is employed to implant a prosthetic heart valve, deflection of the catheter allows for central alignment of the delivery system in the native annulus during deployment of the bioprosthesis.

Abstract: A prosthesis retaining assembly for securing an implantable prosthesis to a catheter assembly can include a first member including a prosthesis retaining slot configured to retain a portion of the prosthesis. The retaining slot can have a first portion with a first width and a second portion with a second width. The first portion can be distal to the second portion. The second width can be larger than the first width, and the retaining slot can have an opening at a first surface of the first member. The prosthesis retaining assembly can also include a second member configured to be move relative to the first member. The second member can be configured to move to a position that obstructs a portion of the opening of the retaining slot.

Abstract: Heart valve prosthesis recapture devices and methods for recapture are disclosed, which can be used for recapturing a partially deployed heart valve prosthesis. The recapture device comprises a recapture sleeve, configured to envelop and collapse a partially deployed heart valve prosthesis. The recapture sleeve comprises a distal end, configured to be securely attached to a guide wire, and a proximal end, comprising an opening along a longitudinal axis of the recapture sleeve. The opening can be configured to expand as it engages the heart valve prosthesis, and be biased toward a closed configuration. An attachment element can interface with the distal end of the recapture sleeve and be securely attached to a guide wire, such as by crimping. The recapture sleeve can include a support structure comprising at least one spine and a plurality of ribs.

Abstract: A guidewire is coupled to a control module and extends through a lumen of the control module. The control module operates to transition between a first control state wherein the control module allows movement of the guidewire relative to a catheter and a second control state wherein relative axial movement between the catheter and guidewire is prevented.

Abstract: The invention features modular implantable ventricular assist devices configured to be, at least in part, assembled within a patient. The devices generally include a pump assembly and an expandable frame. The frame is configured to engage tissue of a patient when implanted. The pump assembly is configured to be operably coupled to the frame when the frame is implanted and in the expanded configuration.

Abstract: A prosthesis for implantation at a native semilunar valve site of a subject can include a support structure configured such that in a first rotational disposition of the prosthesis with respect to the native semilunar valve, a tactile feedback sensation is provided to a user implanting the prosthesis.

Abstract: A guidewire is coupled to a control module and extends through a lumen of the control module. The control module operates to transition between a first control state wherein the control module allows movement of the guidewire relative to a catheter and a second control state wherein relative axial movement between the catheter and guidewire is prevented.

Abstract: Devices and methods for preparing a transcatheter heart valve system. The device includes a housing, sealing apparatuses and a port. The housing forms a chamber sized to receive a prosthetic valve and a portion of a delivery device. During use, the prosthesis is seated in the chamber, and the sealing apparatuses operated to seal the chamber about the delivery device. Air bubbles in a liquid delivered through the delivery device and to the chamber are removed from the system via the port, thereby flushing the system. Further, the device is manipulated to permit loading of the prosthesis into the delivery device in an air bubble-free environment.

Abstract: A transcatheter valve prosthesis is disclosed that has a compressed, delivery configuration and an expanded configuration for deployment within a native heart valve. The valve prosthesis includes a self-expanding frame and a prosthetic valve component. The self-expanding frame includes a valve receiving portion defining an opening therethrough and first and second anchors at opposing ends of the valve receiving portion. The valve receiving portion is substantially planar and the first and second anchors are oriented substantially perpendicular to the valve receiving portion when the valve prosthesis is in the expanded configuration. The prosthetic valve component is disposed within the opening of the valve receiving portion and secured thereto.

Abstract: A device useful for implantation at a native heart valve can include an anchor element having a tubular configuration defining a longitudinal direction and a circumference, a heart valve prosthesis disposed within the anchor element, and a plurality of elongate members positioned at equidistant angular intervals about the circumference of the anchor element. The device can be configured to be transitioned from a radially collapsed delivery configuration to a radially expanded implantation configuration, and the plurality of elongate members can have a length extending in the longitudinal direction of the tubular member in the expanded implantation configuration.

Abstract: A heart valve therapy system including a delivery device and a stented valve. The delivery device includes an outer sheath, an inner shaft, an optional hub assembly, and a plurality of tethers. In a delivery state, a stent frame of the prosthesis is crimped over the inner shaft and maintained in a compressed condition by the outer sheath. The tethers are connected to the stent frame. In a partial deployment state, the outer sheath is at least partially withdrawn, allowing the stent frame to self-expand. Tension in the tethers prevents the stent frame from rapidly expanding and optionally allowing recapture. Upon completion of the stent frame expansion, the tethers are withdrawn.