Abstract: A delivery system for an implantable stented device having a handle with a plurality of actuation members, each actuation member connected to one or more stent attachment elements, a sheath having a proximal end attached to the handle, and a plurality of tubes extending within the sheath. The stent attachment elements extend from distal ends of the tubes. A first actuation member is configured to move a first stent attachment element proximally toward the handle and a second actuation member is configured to move a second stent attachment element proximally toward the handle, sequentially releasing specific portions of the stented device by causing distal ends of the stent attachment elements to contact an exterior of the distal ends of the tubes, thereby disengaging the first and second stent attachment elements from the stented device.

Abstract: In a method of accessing and closing a vessel, a vessel is percutaneously accessed through a first opening in the vessel wall at a first location. A stent-graft is delivered through the first opening to a second location. The stent-graft is deployed at the second location. The vessel is then accessed through a second opening through the vessel wall at the second location, wherein the second opening is generally aligned with a fenestration through the graft material of the stent-graft. A delivery device is advanced through the second opening, the fenestration, and the stent-graft lumen to a third location spaced from the first location and the second location. After the delivery device is retracted through the lumen of the stent-graft and out of the fenestration and the second opening, the stent graft is rotated or translated such that the fenestration is not aligned with the second opening.

Abstract: A delivery system with sequential release mechanism and method of delivering and deploying an implantable stented device into a body lumen including a tabular body, a plurality of activation members extending from the distal end of the tubular body, and a plurality of disks. Each disk includes a proximal and distal surface, at least one stent engagement element attached to the distal surface of the disk and at least one aperture. At least one activation member attaches to the proximal surface of a first disk and at least one activation member passes through an aperture of the first disk and attaches to the proximal surface of a second disk. At least one stent engagement element attached to the distal surface of the first disk passes through an aperture of the second disk. Axially movement of the activation members causes sequential release of the stent engagement elements from a stented device.

Abstract: A stented valve including a stent structure including a generally tubular body portion having a first end, a second end, an interior area, a longitudinal axis, and a plurality of vertical wires extending generally parallel to the longitudinal axis around a periphery of the body portion, wherein the plurality of vertical wires includes multiple commissure wires and at least one structural wire positioned between adjacent commissure wires, and a plurality of V-shaped wire structures having a first end, a second end, and a peak between the first and second ends, wherein a first end of each V-shaped structure extends from a first vertical wire and a second end of each V-shaped structure extends from a second vertical wire that is adjacent to the first vertical wire, wherein each V-shaped structure is oriented so that its peak is facing in the same direction relative to the first and second ends of the body portion, and a valve structure including a plurality of leaflets attached to the stent structure within the

Abstract: A stented valve including a generally tubular stent structure that has a longitudinal axis, first and second opposite ends, a plurality of commissure support structures spaced from the first and second ends and extending generally parallel to the longitudinal axis, at least one structural wire positioned between each two adjacent commissure support structures, and at least one wing portion extending from two adjacent commissure support structures and toward one of the first and second ends of the stent structure. The stented valve further includes a valve structure attached within the generally tubular stent structure to the commissure support structures.

Abstract: A device for percutaneous delivery of a stented prosthetic heart valve. The device includes a sheath, a handle, and an outer stability tube. The sheath includes a distal capsule and a proximal shaft. The handle has a housing maintaining an actuator mechanism that is coupled to the shaft. The actuator mechanism is configured to selectively move the shaft, and thus the capsule, relative to the housing. The stability tube is coupled to the housing and is coaxially received over the shaft such that the shaft is slidable relative to the stability tube. In a delivery state, the capsule encompasses the prosthetic valve. In a deployed state, the capsule is withdrawn from the prosthetic valve. The shaft slides relative to the stability tube in transitioning from the loaded state to the deployed state. When used with an introducer device, the stability tube frictionally isolates the sheath.

Abstract: A stented valve including a stent structure including a generally tubular body portion having a first end, a second end, an interior area, a longitudinal axis, and a plurality of vertical wires extending generally parallel to the longitudinal axis around a periphery of the body portion, wherein the plurality of vertical wires includes multiple commissure wires and at least one structural wire positioned between adjacent commissure wires, and a plurality of V-shaped wire structures having a first end, a second end, and a peak between the first and second ends, wherein a first end of each V-shaped structure extends from a first vertical wire and a second end of each V-shaped structure extends from a second vertical wire that is adjacent to the first vertical wire, wherein each V-shaped structure is oriented so that its peak is facing in the same direction relative to the first and second ends of the body portion, and a valve structure including a plurality of leaflets attached to the stent structure within the

Abstract: A delivery system for use with a prosthetic heart valve having a stent frame to which a valve structure is attached includes a shaft assembly including a distal end, an intermediate portion, and a first coupling structure disposed near the distal end and configured to be coupled to a distal end of the prosthetic heart valve via a first tether. A sheath assembly defines a lumen sized to slidably receive the shaft assembly. The delivery system is configured to transition from a loaded state in which the sheath assembly encompasses the prosthetic heart valve to a deployed state in which the sheath assembly is withdrawn from the prosthetic heart valve. The first coupling structure is configured to be manipulated in a first direction to provide a controlled expansion or contraction of the distal end of the prosthetic heart valve.

Abstract: A device for percutaneous delivery of a stented prosthetic heart valve. The device includes a sheath, a handle, and an outer stability tube. The sheath includes a distal capsule and a proximal shaft. The handle has a housing maintaining an actuator mechanism that is coupled to the shaft. The actuator mechanism is configured to selectively move the shaft, and thus the capsule, relative to the housing. The stability tube is coupled to the housing and is coaxially received over the shaft such that the shaft is slidable relative to the stability tube. In a delivery state, the capsule encompasses the prosthetic valve. In a deployed state, the capsule is withdrawn from the prosthetic valve. The shaft slides relative to the stability tube in transitioning from the loaded state to the deployed state. When used with an introducer device, the stability tube frictionally isolates the sheath.

Abstract: A delivery system with sequential release mechanism and method of delivering and deploying an implantable stented device into a body lumen including a tabular body, a plurality of activation members extending from the distal end of the tubular body, and a plurality of disks. Each disk includes a proximal and distal surface, at least one stent engagement element attached to the distal surface of the disk and at least one aperture. At least one activation member attaches to the proximal surface of a first disk and at least one activation member passes through an aperture of the first disk and attaches to the proximal surface of a second disk. At least one stent engagement element attached to the distal surface of the first disk passes through an aperture of the second disk. Axially movement of the activation members causes sequential release of the stent engagement elements from a stented device.

Abstract: A method of deploying an implantable stented device in an anatomical location of a patient, including the steps of providing a delivery system with first and second stent engagement structures at its distal end, attaching a first structural element of the stented device to the first stent engagement structure and attaching a second structural element of the stented device to the second stent engagement structure, advancing the stented device to an implantation site, and sequentially disengaging the first structural element of the stented device from the first stent engagement structure of the delivery system and then disengaging the second structural element of the stented device from the second stent engagement structure.

Abstract: A delivery system for delivering a stented prosthetic heart valve to a lumen of a patient, the delivery system including a tubular body having a proximal end and a distal end, and a plurality of wires extending from the distal end of the tubular body, wherein each of the wires has a distal end that is coiled for engagement with a stent of a stented prosthetic heart valve.

Abstract: Embodiments of the present invention provide prosthetic valves having sealing members on the external surface thereof. The prosthetic heart valves of the present invention are preferably delivered by catheter directly through the apex of the heart or by other close range transcatheter delivery methods. Because these methods of implantation require a shorter length of catheter, a prosthetic valve can be more accurately oriented in the desired implantation location. Fluoroscopy can be used to further assist in orientation of the valve. The sealing members of the present invention can be positioned on the prosthetic valve such that, when the prosthetic valve is implanted in a native annulus, each provided sealing member is located adjacent to a commissural point of the native valve leaflets. Because the sealing members are precisely oriented on the prosthetic valve, a physician can ensure that the sealing members are aligned with the commissural points of the native valve leaflets.

Abstract: A delivery system for use with a prosthetic heart valve having a stent frame to which a valve structure is attached includes a shaft assembly including a distal end, an intermediate portion, and a first coupling structure disposed near the distal end and configured to be coupled to a distal end of the prosthetic heart valve via a first tether. A sheath assembly defines a lumen sized to slidably receive the shaft assembly. The delivery system is configured to transition from a loaded state in which the sheath assembly encompasses the prosthetic heart valve to a deployed state in which the sheath assembly is withdrawn from the prosthetic heart valve. The first coupling structure is configured to be manipulated in a first direction to provide a controlled expansion or contraction of the distal end of the prosthetic heart valve.

Abstract: A method of remodeling a stented device and an adjacent a valve region of a patient, including the steps of implanting a stented device into a native valve region of a patient, providing a first remodeling ring on a portion of a delivery system, advancing the remodeling ring into an interior area of the implanted stented device with the delivery system, radially expanding the remodeling ring until it modifies at least one of an aspect of a shape of the interior area of the implanted stented device and an aspect of a shape of the valve region in which it is positioned, and removing the delivery system from the patient.

Abstract: A device for percutaneous delivery of a stented prosthetic. heart valve. The device includes a sheath, a handle, and an outer stability tube. The sheath includes a distal capsule and a proximal shaft. The handle has a housing maintaining an actuator mechanism that is coupled to the shaft. The actuator mechanism is configured to selectively move the shaft, and thus the capsule, relative to the housing. The stability tube is coupled to the housing and is coaxially received over the shaft such that the shaft is slidable relative to the stability tube. In a delivery state, the capsule encompasses the prosthetic valve. In a deployed state, the capsule is withdrawn from the prosthetic valve. The shaft slides relative to the stability tube in transitioning from the loaded state to the deployed state. When used with an introducer device, the stability tube frictionally isolates the sheath.

Abstract: A stented valve including a generally tubular stent structure that has a longitudinal axis, first and second opposite ends, a plurality of commissure support structures spaced from the first and second ends and extending generally parallel to the longitudinal axis, at least one structural wire positioned between each two adjacent commissure support structures, and at least one wing portion extending from two adjacent commissure support structures and toward one of the first and second ends of the stent structure. The stented valve further includes a valve structure attached within the generally tubular stent structure to the commissure support structures.

Abstract: A catheter-based heart valve therapy system, includes a stented heart valve prosthesis including a stent frame having a valvular contact region that is configured to make contact with a heart valve and nearby anatomy of a patient. A sizing balloon includes a first region having a shape in an inflated state that matches a shape of the valvular contact region of the stent frame in an expanded state. At least one catheter-based delivery system is configured to deliver the sizing balloon to the heart valve of the patient for a size determination, and deliver the prosthesis to the heart valve for implantation.

Abstract: A stented valve including a stent structure including a generally tubular body portion that has a first end and a second end, wherein an area adjacent the first end has a first stiffness, an area adjacent the second end has a second stiffness, and a central region between the areas at the first and second ends has a third stiffness that is less than the stiffness adjacent the first and second ends, wherein the stent structure can be reconfigured in its central area to match a curved patient anatomical region. The stented valve further includes a valve structure attached within the generally tubular portion.

Abstract: A surgical access device including a lower portion having a central opening spaced from a lower portion outer wall, an upper portion adjacent to the lower portion and having a central opening spaced from an upper portion outer wall, and at least one flange portion extending outwardly from the upper and lower portions. The device can further include a gap extending from the central openings of the lower and upper portions and through their outer walls.