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 In a partial deployment state, the outer sheath is at least partially withdrawn, allowing the stent frame to self-expand.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 Upon completion of the stent frame expansion, the tethers are withdrawn.

Abstract: A delivery system for a prosthetic valve device includes a first shaft including an outflow capture device mounted on a distal end thereof, a second shaft slidingly disposed over the first shaft and including an inflow capture device mounted on a distal end thereof, and a retractable sheath slidingly disposed over the second shaft to hold the prosthetic valve device in a radially compressed configuration for delivery to a body lumen. The inflow capture device is configured for releasable engagement through openings in a plurality of first attachment members on the device. The outflow capture device is configured for releasable engagement through openings in a plurality of second attachment members on the device.

Abstract: A delivery system for a prosthetic valve device includes a first shaft including an outflow capture device mounted on a distal end thereof, a second shaft slidingly disposed over the first shaft and including an inflow capture device mounted on a distal end thereof, and a retractable sheath slidingly disposed over the second shaft to hold the prosthetic valve device in a radially compressed configuration for delivery to a body lumen. The inflow capture device is configured for releasable engagement through openings in a plurality of first attachment members on the device. The outflow capture device is configured for releasable engagement through openings in a plurality of second attachment members on the device.

Abstract: Methods are disclosed for delivering a prosthesis with a delivery catheter comprising a first segment and a second segment. The delivery catheter further comprises a first connector comprising a first portion connected to a distal end of the first segment, and a second portion connected to a proximal end of the second segment, wherein the second portion is rotatably connected to the first portion. The methods comprise percutaneously delivering the prosthesis into a vasculature of a patient with the delivery catheter. The methods further comprise deflecting the delivery catheter to navigate the delivery catheter through bends in the vasculature as the prosthesis is advanced to a treatment site. The deflecting results in relative rotation between the first and second portions of the first connector about an axis of the first connector, and the deflecting results in bending of the first segment and the second segment.

Abstract: Catheters include first and second segments that each include a proximal end and a distal end. A first connector of each catheter includes a first portion connected to the distal end of the first segment and a second portion connected to the proximal end of the second segment. The first portion and the second portion are engaged so that the first portion can rotated relative to the second portion about an axis of the first connector. The first segment and the second segment can bend in multiple planes via a rotation of the first portion relative to the second portion about the axis.

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: Catheters include first and second segments that each include a proximal end and a distal end. A first connector of each catheter includes a first portion connected to the distal end of the first segment and a second portion connected to the proximal end of the second segment. The first portion and the second portion are engaged so that the first portion can rotated relative to the second portion about an axis of the first connector. The first segment and the second segment can bend in multiple planes via a rotation of the first portion relative to the second portion about the axis.

Abstract: The present disclosure provides a catheter including a plurality of a segments, each segment having a stiffener extending along its length. The plurality of segments are interconnected with connectors such that each of the segments can bend in multiple planes via rotation of the connectors.

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: 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: A delivery system for a prosthetic valve device includes a first shaft including an outflow capture device mounted on a distal end thereof, a second shaft slidingly disposed over the first shaft and including an inflow capture device mounted on a distal end thereof, and a retractable sheath slidingly disposed over the second shaft to hold the prosthetic valve device in a radially compressed configuration for delivery to a body lumen. The inflow capture device is configured for releasable engagement through openings in a plurality of first attachment members on the device. The outflow capture device is configured for releasable engagement through openings in a plurality of second attachment members on the device.

Abstract: The present disclosure provides a catheter including a plurality of a segments, each segment having a stiffener extending along its length. The plurality of segments are interconnected with connectors such that each of the segments can bend in multiple planes via rotation of the connectors.

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.

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.

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 valve comprising a stent frame, a valve structure, and a baffle structure. The stent frame defines a lumen. The valve structure is disposed within the lumen, and defines an inflow side and an outflow side. An outflow track is established within the lumen downstream of the outflow side and along which fluid flow from the valve structure progresses. The baffle structure is connected to the stent frame downstream of the outflow side. In some embodiments, the baffle structure directs blood flow into designated areas to encourage laminar flow and eliminate or reduce turbulence.

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.

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.

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: 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.