Abstract: A prosthetic heart may include an expandable frame and prosthetic leaflets that each have a free edge, an attached edge having a contour, a first flat surface facing toward the frame, and a second flat surface facing away from the frame. A spacer fabric may be attached to each leaflet, the spacer fabric having a first surface, a second surface, and an inner matrix between the first and second surfaces.

Abstract: A delivery device for a collapsible prosthetic heart valve includes an inner shaft, an outer shaft, and a distal sheath. The distal sheath may be disposed distal to the outer shaft and about a portion of the inner shaft to form a compartment with the inner shaft. The compartment may be sized to receive the prosthetic heart valve. The inner shaft and the distal sheath may be movable relative to one another. A spine may extend along the outer shaft, the spine biasing the outer shaft so that the outer shaft tends to bend in a pre-determined direction.

Abstract: In some embodiments, a prosthetic heart valve system, includes a prosthetic heart valve including a stent, a cuff and a plurality of leaflets, the cuff and the plurality of leaflets forming a valve assembly, and the stent having one or more retention tabs, and a delivery device having an inner shaft and an expandable balloon transitionable between a deflated state and an inflated state, the delivery device having a hub with one or more receivers to accept the one or more retention tabs.

Abstract: A prosthetic heart valve system includes a balloon expandable prosthetic heart valve and a delivery catheter. The prosthetic heart valve has an inflow end portion, an outflow end portion, and a center portion. The delivery catheter has a balloon assembly on a distal end portion of the delivery catheter having a proximal portion, a distal portion, and a center portion. In a delivery condition of the system, the prosthetic heart valve is crimped over the balloon while the balloon assembly is deflated.

Abstract: A delivery device for a collapsible prosthetic heart valve includes an inner shaft, an outer shaft, and a distal sheath. The distal sheath may be disposed distal to the outer shaft and about a portion of the inner shaft to form a compartment with the inner shaft. The compartment may be sized to receive the prosthetic heart valve. The inner shaft and the distal sheath may be movable relative to one another. A spine may extend along the outer shaft, the spine biasing the outer shaft so that the outer shaft tends to bend in a pre-determined direction.

Abstract: Combined embolic protection devices and prosthetic heart valve delivery devices useful for filtering emboli during a heart valve replacement procedure are described. The delivery devices may include a delivery sheath for housing the prosthetic heart valve in collapsed condition for delivery. The delivery devices may include one or more embolic protection filters received within the delivery device during the delivery of the prosthetic heart valve. The embolic protection filters may be deployed into an expanded or deployed condition prior to deploying the prosthetic heart valve. Any embolic debris entering the bloodstream during the prosthetic heart valve deployment may be trapped within, or deflected by, the deployed embolic filter(s) to reduce the risk of stroke.

Abstract: An implantable delivery system has an inner shaft (20) with a device-carrying region (28) and an outer shaft (40) surrounding the inner shaft. A sheath (41) at a distal end of the outer shaft covers the device-carrying region when the outer shaft is in an advanced position. A sleeve (50) surrounding the outer shaft is in proximity to the sheath when the sleeve is in an advanced position. After insertion, the sleeve is retracted to increase flexibility of the distal end of the device. A handle (62) includes a control element for retracting the outer shaft and sheath relative to the inner shaft to release the implantable device. The sleeve may be fixed to the body of the handle when the sleeve is retracted. Engagement between the sleeve and an introducer at the insertion site can stabilize the handle and inner shaft against movement relative to the patient during retraction of the outer shaft.

Abstract: A delivery device for an implantable medical device includes an inner shaft extending in a longitudinal direction and an outer sheath adapted to surround at least a portion of the inner shaft, the outer sheath being slideable relative to the inner shaft in the longitudinal direction. A compartment defined between the inner shaft and the outer sheath is adapted to receive the medical device in an assembled condition. A retaining assembly positioned at one end of the compartment includes a first member rotatable with respect to the inner shaft, and a second member rotationally fixed with respect to the inner shaft. The medical device includes at least one retainer adapted to be received within at least one retainer slot of the first member. This arrangement enables the medical device to rotate within the compartment as the delivery device is advanced to an implantation site.

Abstract: A delivery device for a prosthetic heart valve includes a shaft, a sheath, and a pull wire. The shaft has a proximal end, a distal end, and a longitudinal axis. The sheath is attached to the shaft and is rotatable about an axis transverse to the longitudinal axis of the shaft. The pull wire is mechanically coupled to the sheath such that movement of the pull wire rotates the sheath relative to the shaft. The sheath may be in a first position relative to the shaft when a distal end of the pull wire is in a first position and may be in a second position when the distal end of the pull wire is in a second position. Deflection of the sheath relative to the shaft enables a prosthetic valve to be axially aligned with the native valve annulus for deployment.

Abstract: A delivery system for delivering a collapsible prosthetic heart valve includes a valve support structure for supporting a collapsible prosthetic heart valve, and a distal sheath movable in a longitudinal direction relative to the valve support structure between a first position in which the distal sheath is adapted to surround a collapsible prosthetic heart valve supported on the valve support structure, and a second position in which the distal sheath is adapted to expose the collapsible prosthetic heart valve for deployment. The distal sheath is at least partially formed of an inner polymer layer, an outer polymer layer, and a tubular supporting member sandwiched between the inner polymer layer and the outer polymer layer.

Abstract: A delivery device for an implantable medical device includes an inner shaft extending in a longitudinal direction and an outer sheath adapted to surround at least a portion of the inner shaft, the outer sheath being slideable relative to the inner shaft in the longitudinal direction. A compartment defined between the inner shaft and the outer sheath is adapted to receive the medical device in an assembled condition. A retaining assembly positioned at one end of the compartment includes a first member rotatable with respect to the inner shaft, and a second member rotationally fixed with respect to the inner shaft. The medical device includes at least one retainer adapted to be received within at least one retainer slot of the first member. This arrangement enables the medical device to rotate within the compartment as the delivery device is advanced to an implantation site.

Abstract: An implantable delivery system has an inner shaft (20) with a device-carrying region (28) and an outer shaft (40) surrounding the inner shaft. A sheath (41) at a distal end of the outer shaft covers the device-carrying region when the outer shaft is in an advanced position. A sleeve (50) surrounding the outer shaft is in proximity to the sheath when the sleeve is in an advanced position. After insertion, the sleeve is retracted to increase flexibility of the distal end of the device. A handle (62) includes a control element for retracting the outer shaft and sheath relative to the inner shaft to release the implantable device. The sleeve may be fixed to the body of the handle when the sleeve is retracted. Engagement between the sleeve and an introducer at the insertion site can stabilize the handle and inner shaft against movement relative to the patient during retraction of the outer shaft.

Abstract: A delivery system for delivering a collapsible prosthetic heart valve includes a valve support structure for supporting a collapsible prosthetic heart valve, and a distal sheath movable in a longitudinal direction relative to the valve support structure between a first position in which the distal sheath is adapted to surround a collapsible prosthetic heart valve supported on the valve support structure, and a second position in which the distal sheath is adapted to expose the collapsible prosthetic heart valve for deployment. The distal sheath is at least partially formed of an inner polymer layer, an outer polymer layer, and a tubular supporting member sandwiched between the inner polymer layer and the outer polymer layer.

Abstract: A delivery system for delivering a collapsible prosthetic heart valve includes a valve support structure for supporting a collapsible prosthetic heart valve, and a distal sheath movable in a longitudinal direction relative to the valve support structure between a first position in which the distal sheath is adapted to surround a collapsible prosthetic heart valve supported on the valve support structure, and a second position in which the distal sheath is adapted to expose the collapsible prosthetic heart valve for deployment. The distal sheath is at least partially formed of an inner polymer layer, an outer polymer layer, and a tubular supporting member sandwiched between the inner polymer layer and the outer polymer layer.

Abstract: A delivery device for a prosthetic heart valve includes a shaft, a sheath, and a pull wire. The shaft has a proximal end, a distal end, and a longitudinal axis. The sheath is attached to the shaft and is rotatable about an axis transverse to the longitudinal axis of the shaft. The pull wire is mechanically coupled to the sheath such that movement of the pull wire rotates the sheath relative to the shaft. The sheath may be in a first position relative to the shaft when a distal end of the pull wire is in a first position and may be in a second position when the distal end of the pull wire is in a second position. Deflection of the sheath relative to the shaft enables a prosthetic valve to be axially aligned with the native valve annulus for deployment.

Abstract: A delivery device for a prosthetic heart valve includes a shaft, a sheath, and a pull wire. The shaft has a proximal end, a distal end, and a longitudinal axis. The sheath is attached to the shaft and is rotatable about an axis transverse to the longitudinal axis of the shaft. The pull wire is mechanically coupled to the sheath such that movement of the pull wire rotates the sheath relative to the shaft. The sheath may be in a first position relative to the shaft when a distal end of the pull wire is in a first position and may be in a second position when the distal end of the pull wire is in a second position. Deflection of the sheath relative to the shaft enables a prosthetic valve to be axially aligned with the native valve annulus for deployment.

Abstract: Retainer structures (150) maintain stented valves (800) on the balloon (130) of a balloon catheter during delivery of the valve to an implantation node and subsequent expansion of the valve. The retainer structures define a raised edge relative to the outer surface of the balloon and limit movement of the valve longitudinally relative to the balloon. Deflation of the balloon following expansion of the valve stent releases the valve.

Abstract: A catheter assembly having first and second shaft members that provide stearability for the catheter assembly. The first shaft member has a plurality of longitudinally spaced apart first ring members that are interconnected with a longitudinally extended first spine member. The second shaft member is positioned within the first shaft member and is connected to a distal end portion of the first shaft member. The second shaft member has a plurality of longitudinally spaced apart second ring members that are interconnected with a longitudinally extending second spine member. Alternatively, the second shaft member includes a plurality of protrusions extending radially outward from the longitudinally extending second spine member. The second shaft member is operable to move at least portions of the first ring members longitudinally relative to each other to bend the first shaft member.

Abstract: A method of testing the performance of a collapsible prosthetic heart valve includes wrapping an aortic band around an outer surface of a portion of an aorta, fastening a first end portion of the aortic band to a second end portion of the aortic band, implanting a collapsible prosthetic heart valve in the aorta at an implantation site, and flowing a pressurized fluid through the aorta. The aortic band may be positioned near the sinotubular junction of the aorta. When installed around the aorta, the aortic band reinforces the portion of the aorta so as to be more resistant to radial expansion.

Abstract: A method of testing the performance of a collapsible prosthetic heart valve includes wrapping an aortic band around an outer surface of a portion of an aorta, fastening a first end portion of the aortic band to a second end portion of the aortic band, implanting a collapsible prosthetic heart valve in the aorta at an implantation site, and flowing a pressurized fluid through the aorta. The aortic band may be positioned near the sinotubular junction of the aorta. When installed around the aorta, the aortic band reinforces the portion of the aorta so as to be more resistant to radial expansion.