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: A method of manufacturing a prosthetic heart valve includes coupling a plurality of prosthetic leaflets to each other, and coupling the plurality of prosthetic leaflets to a cuff, to form a valve assembly. The valve assembly may be coupled to a stent to form the prosthetic heart valve. The valve assembly may be formed prior to the plurality of prosthetic leaflets being coupled to the stent and prior to the cuff being coupled to the stent.

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 may include a balloon expandable prosthetic heart valve and a delivery catheter. The delivery catheter may have a balloon on a distal end portion of the delivery catheter. In a delivery condition of the system and in an activated condition of the system, the prosthetic heart valve is mounted over the balloon so that a leading edge of the prosthetic heart valve points toward a distal end of the delivery catheter and so that the prosthetic heart valve has an outer radial extent. The delivery catheter may include a protective member operably coupled to the delivery catheter. In the delivery condition of the system, the protective member does not extend radially beyond the outer radial extent of the prosthetic heart valve. In the activated condition of the system, the protective member does extend radially beyond the outer radial extent of the prosthetic heart valve.

Abstract: A method of implanting a prosthetic heart valve includes delivering the prosthetic heart valve to a native valve annulus while the prosthetic heart valve is crimped over a deflated balloon of a delivery device. The method may include advancing fluid through the delivery device and into the balloon to inflate the balloon and to expand the prosthetic heart valve into the native valve annulus. The method may include monitoring a pressure within the delivery device while advancing fluid through the delivery device. The method may also include displaying the monitored pressure on a display device in real time during monitoring the pressure.

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: 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 being sized to receive the prosthetic heart valve in a collapsed condition. The inner shaft and the distal sheath may be movable relative to one another. The delivery device may also include a tube member and an outer sleeve overlying the tube member. The tube member may be configured to rotate or twist upon axial movement of the outer sleeve with respect to the tube member, the rotation or twisting of the tube member configured to rotate the prosthetic heart valve when the prosthetic heart valve is received within the compartment in the collapsed condition.

Abstract: A guidewire may be configured for insertion into a heart of a patient during a procedure such as a transcatheter aortic valve replacement procedure. The guidewire may include a proximal end and a distal end portion. The distal end portion may include (i) a leading section, (ii) a loop structure at a terminal distal end of the guidewire, and (iii) a transition section extending between the leading section and the loop structure. In the absence of applied forces, the leading section is not tangential to the loop structure. With such a configuration, the guidewire may avoid contact with the ventricular septum of the heart when the loop structure is seated within the left ventricle, which may mitigate potential interference with conduction pathways in the ventricular septum, which may in turn mitigate the need for a pacemaker.

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 guide wire for biological pressure measurement includes: a tube extending along an axial direction of the guide wire, wherein the tube includes a circumferential wall and defines a proximal-end opening and a distal-end opening; and a pressure sensor configured for biological pressure measurement, wherein at least a portion of the pressure sensor is mounted within the tube, and wherein the pressure sensor comprises a pressure sensor transducer. The circumferential wall of the tube includes exactly three openings configured for fluid and gas ingress and egress extending radially therethrough.

Abstract: A transcatheter valve delivery system includes a longitudinal member extending between a proximal end and a distal end, and having a compartment adjacent the distal end for holding a medical device in a collapsed condition. An alignment element is connected to the longitudinal member and is movable relative to the longitudinal member between a stowed position and a deployed position. In the deployed position, the alignment element is configured to urge against an anatomical surface to position the longitudinal member at a desired location relative to the anatomical surface.

Abstract: An introducer for providing access to a surgical site in a patient includes a sheath having an interior diameter that is expandable from a reduced diameter configuration to an increased diameter configuration. The introducer may be inserted into and removed from the patient while the sheath is in the reduced diameter configuration to minimize trauma to the patient's vasculature. Once inserted into the patient's vasculature, the sheath may be expanded to the expanded diameter configuration to allow for secondary devices, such as delivery devices, to be passed through the interior of the sheath. The sheath may include a frame having a mechanism to enable it to expand or collapse. The frame mechanisms may include coiled wires, flexible rings, spine structures with deflectable ribs, non-auxetic expandable and collapsible cellular patterns, and auxetic expandable and collapsible cellular patterns.

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 transcatheter valve delivery system includes a longitudinal member extending between a proximal end and a distal end, and having a compartment adjacent the distal end for holding a medical device in a collapsed condition. An alignment element is connected to the longitudinal member and is movable relative to the longitudinal member between a stowed position and a deployed position. In the deployed position, the alignment element is configured to urge against an anatomical surface to position the longitudinal member at a desired location relative to the anatomical surface.

Abstract: A steerable guide wire includes a core wire having a proximal end and a distal end. A braided filament is affixed to the distal end of the core wire. An outer coil surrounds at least a portion of the core wire and the braided filament. A proximal end of the braided filament is secured to a distal end of the coil. By locating the braided filament in the distal tip portion of the guide wire, a guide wire is provided that is highly flexible, has a high degree of tensile integrity, and is highly steerable, even in tortuous vasculature. Filter and balloon catheters having braided filaments at the distal end are also described.

Abstract: A steerable guide wire includes a core wire having a proximal end and a distal end. A braided filament is affixed to the distal end of the core wire. An outer coil surrounds at least a portion of the core wire and the braided filament. A proximal end of the braided filament is secured to a distal end of the coil. By locating the braided filament in the distal tip portion of the guide wire, a guide wire is provided that is highly flexible, has a high degree of tensile integrity, and is highly steerable, even in tortuous vasculature. Filter and balloon catheters having braided filaments at the distal end are also described.