Abstract: A delivery device for implanting a prosthetic heart valve. The device includes an inner shaft assembly, an outer sheath and a connector assembly. The inner shaft assembly defines a guide wire lumen. The outer sheath is slidably received over the inner shaft assembly, and forms an exit port proximate a distal end thereof. The connector assembly establishes a guide wire passageway between the guide wire lumen and the exit port. The connector assembly is configured to permit sliding movement of the outer sheath relative to the inner shaft assembly when deploying the prosthetic heart valve. The connector assembly can include first and second tubes that are slidable relative to one another in facilitating movement of the outer sheath relative to the inner shaft assembly.

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: A modular valve prosthesis includes an inflow stent, a valve component including a valve stent and a prosthetic valve, and an outflow stent. In a radially compressed delivery configuration, an inflow end of the valve stent is separated from an outflow end of the inflow stent and an outflow end of the valve stent is separated from an inflow end of the outflow stent. In a radially expanded deployed configuration, the inflow end of the valve stent is in contact with the outflow end of the inflow stent and the outflow end of the valve stent is in contact with the inflow end of the outflow stent. A delivery system includes a capsule including first, second and third sections and flexible first and second bands between respective sections. The modules of the modular valve prosthesis are aligned with the sections and gaps between the modules are aligned with the bands.

Abstract: A modular valve prosthesis includes an inflow stent, a valve component including a valve stent and a prosthetic valve, and an outflow stent. In a radially compressed delivery configuration, an inflow end of the valve stent is separated from an outflow end of the inflow stent and an outflow end of the valve stent is separated from an inflow end of the outflow stent. In a radially expanded deployed configuration, the inflow end of the valve stent is in contact with the outflow end of the inflow stent and the outflow end of the valve stent is in contact with the inflow end of the outflow stent. A delivery system includes a capsule including first, second and third sections and flexible first and second bands between respective sections. The modules of the modular valve prosthesis are aligned with the sections and gaps between the modules are aligned with the bands.

Abstract: A delivery system includes a handle, an inner shaft having a distal portion configured to receive the heart valve prosthesis thereon, a push wire slidingly disposed through a lumen of the inner shaft, and an outer sheath configured to cover the heart valve prosthesis during delivery. A split distal tip or nosecone is attached to a distal end of the inner shaft and includes at least one cutout portion formed through a sidewall thereof. A proximal end of the push wire is operatively coupled to an actuator of the handle and a distal end of the push wire is attached to the cutout portion of the nosecone. When the nosecone is in a delivery configuration the cutout portion is substantially flush with the sidewall of the nosecone. When the nosecone is in a deployed configuration the cutout portion is spaced apart from the sidewall of the nosecone.

Abstract: An expandable introducer sheath provided with a steering mechanism is disclosed. The introducer sheath is configured for providing a prosthesis delivery system percutaneous access to a patient's vasculature. The introducer sheath includes a sheath component defining a central lumen and having a longitudinally-extending, radially-expandable portion. The sheath component also includes a steering wire slidably disposed within a wall thereof that longitudinally extends along the radially-expandable portion. When the steering wire is in a slackened configuration, the steering wire permits a width of the radially-expandable portion to increase. When the steering wire is in a taut configuration, the steering wire permits a distal portion of the sheath component to be manipulated or bent in order to align a distal port of the introducer sheath, for instance, with an ostium of a branch vessel.

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 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 method of preventing paravalvular leakage includes concurrent delivery of a heart valve prosthesis and an annular sealing component. During delivery, the sealing component is moved from a first position to a second position of the heart valve prosthesis which is longitudinally spaced apart from the first position of the heart valve prosthesis. The sealing component is secured around the heart valve prosthesis at the second position by a contoured outer surface of the heart valve prosthesis. The sealing component may be a flexible ring or may be a cylindrical flexible sleeve having a plurality of ribs longitudinally extending over the cylindrical sleeve. The ribs operate to deploy the sealing component such that at least a portion of the cylindrical sleeve buckles outwardly away from the outer surface of the heart valve prosthesis.

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 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: 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: Heart valve delivery systems and methods of delivering and implanting heart valves using delivery catheters are disclosed. The delivery systems can include a handle assembly which can include a first control mechanism, a second control mechanism, and a decoupling mechanism. The delivery systems can also include a delivery catheter extending from the handle assembly. The delivery catheter can include an outer shaft, which can be controlled by the first control mechanism; a prosthesis containing capsule comprising a proximal capsule portion connected to the outer shaft, and a distal capsule portion releasably coupled to the proximal capsule portion. After deploying a valve prosthesis, the capsule can be closed by activating the decoupling mechanism in the handle to rapidly close the distal and proximal capsule portions together. The delivery system can also include a centering element to guide the distal and proximal capsule portions together.

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: In some embodiments, a medical device delivery system includes a catheter and a retainer. The retainer can be engaged with the medical device to restrain relative movement of the medical device in one or more axial and/or radial directions. A variety of retainers and retainer systems are disclosed, many of which can reliably disengage the medical device from the retainer. Methods for using the medical device delivery system are also described.

Abstract: A delivery device for implanting a prosthetic heart valve. The device includes an inner shaft assembly, an outer sheath and a connector assembly. The inner shaft assembly defines a guide wire lumen. The outer sheath is slidably received over the inner shaft assembly, and forms an exit port proximate a distal end thereof. The connector assembly establishes a guide wire passageway between the guide wire lumen and the exit port. The connector assembly is configured to permit sliding movement of the outer sheath relative to the inner shaft assembly when deploying the prosthetic heart valve. The connector assembly can include first and second tubes that are slidable relative to one another in facilitating movement of the outer sheath relative to the inner shaft assembly.

Abstract: In some embodiments, a medical device delivery system includes a catheter and a retainer. The retainer can be engaged with the medical device to restrain relative movement of the medical device in one or more axial and/or radial directions. A variety of retainers and retainer systems are disclosed, many of which can reliably disengage the medical device from the retainer. Methods for using the medical device delivery system are also described.

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.