Abstract: An expandable introducer includes a hub and a tubular sheath (121) coupled thereto. The tubular sheath (121) defines a central lumen (103). A circumference of the tubular sheath includes a full thickness region (162) having a first wall thickness (T2) and a reduced thickness region (161) having a second wall thickness (T1) smaller than the first wall thickness (T2). The reduced thickness region (162) is configured to be folded such that the tubular sheath includes an unexpanded, folded state and is configured to expand to an expanded, unfolded state in response to a device passing though the central lumen (103). A first outer diameter of the tubular sheath in the unexpanded, folded state is smaller than a second outer diameter of the tubular sheath in the expanded, unfolded state.

Abstract: A transcatheter valve prosthesis includes a stent having a crimped configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve. The stent includes at least one axial frame member. The transcatheter valve prosthesis includes at least one outflow marker positioned on the at least one axial frame member. The transcatheter heart valve prosthesis may include inflow markers positioned within the inflow portion of the stent. The transcatheter heart valve prosthesis may include two outflow markers disposed on axial frame members, the two outflow markers being circumferentially and longitudinally offset from each other. The markers are configured to aid in axial and circumferential alignment of the transcatheter heart valve prosthesis within a native heart valve.

Abstract: An advancer includes an advancer hub and an advancer shaft extending distally from the advancer hub. The advancer shaft includes a proximal end, a distal end, and a lumen extending from the proximal end to the distal end. The advancer shaft is configured to be disposed around an outer shaft of a delivery catheter, and includes a split line configured to enable splitting the shaft to enable removal of the shaft from the outer shaft. The advancer hub configured to be mounted on the outer shaft of the delivery catheter, and includes a parting line to enable splitting of the advancer hub.

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: A transcatheter valve prosthesis includes a stent and a prosthetic valve. The stent includes an inflow portion, an outflow portion, and a transition portion extending between the inflow portion and the outflow portion. The transition portion includes a plurality of axial frame members, and three of the plurality of the axial frame members are commissure posts. At least two of the plurality of the axial frame members are commissure posts having a first end connected to a crown of the inflow portion and an unattached second end disposed within the outflow portion such that a pair of struts of the outflow portion intersect each commissure post at a mid-portion thereof. The prosthetic valve is configured to substantially block blood flow in one direction to regulate blood flow through a central lumen of the stent.

Abstract: A transcatheter valve prosthesis includes a stent having a crimped configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve. The stent includes at least one axial frame member. The transcatheter valve prosthesis includes at least one outflow marker positioned on the at least one axial frame member. The transcatheter heart valve prosthesis may include inflow markers positioned within the inflow portion of the stent. The transcatheter heart valve prosthesis may include two outflow markers disposed on axial frame members and being circumferentially and longitudinally offset from each other. The markers are configured to aid in axial and circumferential aligned of the transcatheter heart valve prosthesis within a native heart valve.

Abstract: A transcatheter valve prosthesis includes a stent and a prosthetic valve. The stent includes an inflow portion, an outflow portion, and a transition portion extending between the inflow portion and the outflow portion. The transition portion includes a plurality of axial frame members, and three of the plurality of the axial frame members are commissure posts. At least two of the plurality of the axial frame members are commissure posts having a first end connected to a crown of the inflow portion and an unattached second end disposed within the outflow portion such that a pair of struts of the outflow portion intersect each commissure post at a mid-portion thereof. The prosthetic valve is configured to substantially block blood flow in one direction to regulate blood flow through a central lumen of the stent.

Abstract: A transcatheter heart valve prosthesis and a method of assembling the transcatheter heart valve prosthesis are disclosed. The heart valve prosthesis includes a valve-skirt assembly having an inner skirt, a frame, an outer wrap backing and an outer wrap. The method includes: tacking the valve-skirt assembly within the frame; attaching the inner skirt below commissure posts of the frame; attaching commissures of the valve component to the commissure posts; attaching a plurality of outer wrap backings to the inner skirt; attaching the outer wrap backings and the inner skirt to the frame; attaching tissue bumpers to struts in an outflow section of the frame; attaching an outer wrap and the inner skirt to the frame; attaching the outer wrap to the inner skirt proximate inflow edges thereof; and attaching the outer wrap to the inner skirt and to the outer wrap backings proximate respective outflow edges thereof.

Abstract: A system includes a medical device for implanting in a valve of a subject, the implantable medical device having a self-expanding frame; and a holder configured to retain the frame of the implantable medical device in a constricted configuration and to control expansion of the frame. The holder has a controllably constrictable and expandable loop, wherein the loop is disposed about at least a portion of the self-expanding frame such that constriction or expansion of the first loop controls constriction or expansion of the frame.

Abstract: A system includes a medical device for implanting in a valve of a subject, the implantable medical device having a self-expanding frame; and a holder configured to retain the frame of the implantable medical device in a constricted configuration and to control expansion of the frame. The holder has a controllably constrictable and expandable loop, wherein the loop is disposed about at least a portion of the self-expanding frame such that constriction or expansion of the first loop controls constriction or expansion of the frame.

Abstract: A method of delivering and deploying a prosthetic valve includes percutaneously advancing a catheter to a treatment site, proximally retracting an outer shaft relative to an inner shaft to expose the prosthetic valve such that the prosthetic valve self-expands to a radially expanded configuration, disconnecting a tip retractor from a handle of the catheter, and proximally retracting the tip retractor to proximally retract the inner shaft and a nosecone attached to a distal end of the inner shaft relative to the outer shaft and/or the handle.

Abstract: A tray and packaging system for a prosthetic valve delivery system permits conversion from a storage and/or shipping configuration to a set up and preparation configuration. In a first configuration, a delivery system can be supported by first and second main trays with the elongate catheter of the delivery system arranged to extend linearly from the first main tray to the second main tray, and in a second configuration, the delivery system can be supported by the first and second main trays with the elongate catheter of the delivery system turned back in a U-shaped manner with the deployment portion of the delivery system positioned to the side of the control handle portion of the delivery system.

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: 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: A transcatheter valve prosthesis includes a stent having a crimped configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve. The stent includes at least one axial frame member. The transcatheter valve prosthesis includes at least one outflow marker positioned on the at least one axial frame member. The transcatheter heart valve prosthesis may include inflow markers positioned within the inflow portion of the stent. The transcatheter heart valve prosthesis may include two outflow markers disposed on axial frame members and being circumferentially and longtiduinally offset from each other. The markers are configured to aid in axial and circumferential aligned of the transcatheter heart valve prosthesis within a native heart valve.

Abstract: A transcatheter valve prosthesis includes a stent and a prosthetic valve. The stent includes an inflow portion, an outflow portion, and a transition portion extending between the inflow portion and the outflow portion. The transition portion includes a plurality of axial frame members, and three of the plurality of the axial frame members are commissure posts. At least two of the plurality of the axial frame members are commissure posts having a first end connected to a crown of the inflow portion and an unattached second end disposed within the outflow portion such that a pair of struts of the outflow portion intersect each commissure post at a mid-portion thereof. The prosthetic valve is configured to substantially block blood flow in one direction to regulate blood flow through a central lumen of the stent.

Abstract: A tray and packaging system for a prosthetic valve delivery system permits conversion from a storage and/or shipping configuration to a set up and preparation configuration. In a first configuration, a delivery system can be supported by first and second main trays with the elongate catheter of the delivery system arranged to extend linearly from the first main tray to the second main tray, and in a second configuration, the delivery system can be supported by the first and second main trays with the elongate catheter of the delivery system turned back in a U-shaped manner with the deployment portion of the delivery system positioned to the side of the control handle portion of the delivery system.

Abstract: A system includes a medical device for implanting in a valve of a subject, the implantable medical device having a self-expanding frame; and a holder configured to retain the frame of the implantable medical device in a constricted configuration and to control expansion of the frame. The holder has a controllably constrictable and expandable loop, wherein the loop is disposed about at least a portion of the self-expanding frame such that constriction or expansion of the first loop controls constriction or expansion of the frame.

Abstract: A tray and packaging system for a prosthetic valve delivery system permits conversion from a storage and/or shipping configuration to a set up and preparation configuration. In a first configuration, a delivery system can be supported by first and second main trays with the elongate catheter of the delivery system arranged to extend linearly from the first main tray to the second main tray, and in a second configuration, the delivery system can be supported by the first and second main trays with the elongate catheter of the delivery system turned back in a U-shaped manner with the deployment portion of the delivery system positioned to the side of the control handle portion of the delivery system.

Abstract: A system includes a medical device for implanting in a valve of a subject, the implantable medical device having a self-expanding frame; and a holder configured to retain the frame of the implantable medical device in a constricted configuration and to control expansion of the frame. The holder has a controllably constrictable and expandable loop, wherein the loop is disposed about at least a portion of the self-expanding frame such that constriction or expansion of the first loop controls constriction or expansion of the frame.