Abstract: According to one aspect of the disclosure, a delivery device may include a handle, a catheter sheath extending distally from the handle, and a hemostasis valve positioned within the handle. The hemostasis valve may be located proximal to the catheter sheath and distal to a proximal end of the handle. The delivery device may also include a hemostasis bypass assembly coupled to the handle. The hemostasis bypass assembly may include a bypass tube coupled to an actuator. The actuator may be configured to be transitioned between a first condition in which a distal end of the bypass tube is positioned proximal to the hemostasis valve and the hemostasis valve is closed, and a second condition in which the distal end of the bypass tube traverses the hemostasis valve and the hemostasis valve is opened.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent extending along a longitudinal axis and having an inflow end and an outflow end, the stent including a plurality of cells annularly arranged around the stent in at least one row, the plurality of cells having a first nesting cell adjacent the outflow end of the stent, a first engaging arm disposed within the first nesting cell and being pivotally movable between a loaded condition, a partially-released condition, and a fully-released condition, the first engaging arm and the first nesting cell having a synchronous pivoting movement, and a collapsible and expandable valve assembly disposed within the stent and having a plurality of leaflets.

Abstract: A prosthetic heart valve having an inflow end and an outflow end includes a stent having a collapsed condition, an expanded condition, and cells arranged in circumferential rows. The stent has an anterior side configured to be disposed adjacent an anterior native valve leaflet and a posterior side configured to be disposed adjacent a posterior native valve leaflet. A valve assembly having a plurality of leaflets is disposed within the stent and a flange is disposed about the stent. The flange includes a flared portion adjacent the inflow end and a body portion extending from the flared portion to the outflow end, the flange extending between a first set of attachment points adjacent the inflow end, and a second set of attachment points adjacent the outflow end.

Abstract: A prosthetic heart valve may include a stent, a valve assembly, a flange, and a plurality of coupling tubes. The stent may have a collapsed condition, an expanded condition, and a plurality of cells arranged in circumferential rows, the stent having a longitudinal axis, an inflow end and an outflow end. The valve assembly may be disposed within the stent. The flange may comprise a plurality of braided wires and may have a flared portion. The plurality of coupling tubes may couple the flange to the stent so that the flared portion is adjacent the inflow end of the stent. Each of the coupling tubes may have a first end receiving corresponding ones of the braided wires and a second end coupled to a corresponding portion of the stent.

Abstract: A method of delivering a collapsible prosthetic heart valve may include providing a delivery device having a catheter assembly and an operating handle. The catheter assembly may include a compartment adapted to receive the valve and a slidable distal sheath. The operating handle may include a housing and first and second lead screws each movable in first and second opposite longitudinal directions. The method may include loading the valve into the compartment and covering the compartment and the valve with proximal and distal segments of the distal sheath. The method may include inserting the catheter assembly into the patient, and partially deploying the valve by moving the first lead screw in the first longitudinal direction. The method may include fully deploying the valve by simultaneously continuing movement of the first lead screw in the first longitudinal direction and moving the second lead screw in the second longitudinal direction.

Abstract: A prosthetic heart valve includes stabilization features for anchoring the prosthetic heart valve within a native valve annulus. The prosthetic heart valve includes an expandable stent having an inflow end and an outflow end, and a valve assembly disposed within the stent. One such stabilization feature is a collapsible and an expandable frame formed of compliant wires. The frame has a body including a first end coupled to the stent, a second end, and a lumen extending therethrough for receiving the stent and the valve assembly. When the frame is expanded in the native valve annulus, the compliant wires form an indented region in the frame between the first and second ends of the body and a sub-annulus portion of the frame forms a bulge.

Abstract: A delivery device for a prosthetic heart valve includes a catheter assembly and an operating handle. The catheter assembly may include an inner shaft around which a compartment for the heart valve is defined, and a distal sheath having proximal and distal segments configured to enclose the compartment. The handle may include a first lead screw coupled to the proximal segment and a second lead screw coupled to the distal segment. Actuation of the first lead screw operates to move the proximal segment of the distal sheath proximally and actuation of the second lead screw operates to move the distal segment of the distal sheath distally to uncover the compartment and deploy the heart valve.

Abstract: A delivery device for a prosthetic mitral valve includes five sheaths and a handle. The first sheath is coupled to a first handle portion and is rotatable and bendable. The second sheath is coupled to a second handle portion and extends through the first sheath. The second sheath is bendable, rotatable and translatable relative to the first sheath. The third sheath is coupled to a third handle portion and extends through the first and second sheaths. The third sheath is translatable relative to the second sheath. The second handle portion is coupled to the first and third handle portions. The fourth sheath extends through the third sheath and forms part of a compartment to store the prosthetic valve. The fifth sheath extends through the fourth sheath to a tip and is coupled to a retaining sheath that closes the compartment to retain the valve in a collapsed condition.

Abstract: A method of delivering a collapsible prosthetic heart valve may include providing a delivery device having a catheter assembly and an operating handle. The catheter assembly may include a compartment adapted to receive the valve and a slidable distal sheath. The operating handle may include a housing and first and second lead screws each movable in first and second opposite longitudinal directions. The method may include loading the valve into the compartment and covering the compartment and the valve with proximal and distal segments of the distal sheath. The method may include inserting the catheter assembly into the patient, and partially deploying the valve by moving the first lead screw in the first longitudinal direction. The method may include fully deploying the valve by simultaneously continuing movement of the first lead screw in the first longitudinal direction and moving the second lead screw in the second longitudinal direction.

Abstract: A delivery device for a collapsible prosthetic heart valve may include a catheter assembly and an operating handle. The catheter assembly may include an inner shaft around which a compartment is defined, and a distal sheath having proximal and distal segments configured to enclose the compartment. The operating handle may include a first lead screw fixedly coupled to the proximal segment, a second lead screw coupled to the distal segment, a knob rotatable relative to a housing of the operating handle and threadedly engaged with the first lead screw, and a coupling assembly. The coupling assembly may have a first condition in which rotation of the knob in one direction moves the first lead screw but not the second lead screw, and a second condition in which rotation of the knob in the one direction simultaneously moves the first lead screw and the second lead screw.

Abstract: A prosthetic heart valve may include a stent, a valve assembly, a flange, and a plurality of coupling tubes. The stent may have a collapsed condition, an expanded condition, and a plurality of cells arranged in circumferential rows, the stent having a longitudinal axis, an inflow end and an outflow end. The valve assembly may be disposed within the stent. The flange may comprise a plurality of braided wires and may have a flared portion. The plurality of coupling tubes may couple the flange to the stent so that the flared portion is adjacent the inflow end of the stent. Each of the coupling tubes may have a first end receiving corresponding ones of the braided wires and a second end coupled to a corresponding portion of the stent.

Abstract: A prosthetic heart valve having an inflow end and an outflow end includes a stent having a collapsed condition, an expanded condition, and cells arranged in circumferential rows. The stent has an anterior side configured to be disposed adjacent an anterior native valve leaflet and a posterior side configured to be disposed adjacent a posterior native valve leaflet. A valve assembly having a plurality of leaflets is disposed within the stent and a flange is disposed about the stent. The flange includes a flared portion adjacent the inflow end and a body portion extending from the flared portion to the outflow end, the flange extending between a first set of attachment points adjacent the inflow end, and a second set of attachment points adjacent the outflow end.

Abstract: A prosthetic heart valve having an inflow end and an outflow end includes a stent having a collapsed condition, an expanded condition, and cells arranged in circumferential rows. The stent has an anterior side configured to be disposed adjacent an anterior native valve leaflet and a posterior side configured to be disposed adjacent a posterior native valve leaflet. A valve assembly having a plurality of leaflets is disposed within the stent and a flange is disposed about the stent. The flange includes a flared portion adjacent the inflow end and a body portion extending from the flared portion to the outflow end, the flange extending between a first set of attachment points adjacent the inflow end, and a second set of attachment points adjacent the outflow end.

Abstract: A prosthetic heart valve having an inflow end, an outflow end and a longitudinal axis extending from the inflow end to the outflow end includes a collapsible and expandable stent including a plurality of cells arranged in at least one row extending around a circumference of the stent. The stent further includes at least one engaging arm joined to one of the cells adjacent the outflow end and having a free end extending toward the inflow end, the engaging arm being movable between a loaded condition in which the engaging arm is oriented substantially parallel with the longitudinal axis of the stent, a partially-released condition in which the engaging arm forms a first angle with the longitudinal axis of the stent, and a fully-released condition in which the engaging arm forms a second angle with the longitudinal axis of the stent, the first angle being larger than the second angle.

Abstract: A therapeutic device includes a prosthetic heart valve including a collapsible and expandable stent having an aortic section and an annulus section, and a valve assembly disposed within the annulus section of the stent, the valve assembly including a plurality of leaflets; and a graft coupled to the aortic section of the stent. The graft has a body and at least one lining disposed on the body and defining a lumen therethrough.

Abstract: A prosthetic heart valve having an inflow end, an outflow end and a longitudinal axis extending from the inflow end to the outflow end includes a collapsible and expandable stent including a plurality of cells arranged in at least one row extending around a circumference of the stent. The stent further includes at least one engaging arm joined to one of the cells adjacent the outflow end and having a free end extending toward the inflow end, the engaging arm being movable between a loaded condition in which the engaging arm is oriented substantially parallel with the longitudinal axis of the stent, a partially-released condition in which the engaging arm forms a first angle with the longitudinal axis of the stent, and a fully-released condition in which the engaging arm forms a second angle with the longitudinal axis of the stent, the first angle being larger than the second angle.

Abstract: A delivery device for a prosthetic heart valve includes a catheter assembly and an operating handle. The catheter assembly may include an inner shaft around which a compartment for the heart valve is defined, and a distal sheath having proximal and distal segments configured to enclose the compartment. The handle may include a first lead screw coupled to the proximal segment and a second lead screw coupled to the distal segment. Actuation of the first lead screw operates to move the proximal segment of the distal sheath proximally and actuation of the second lead screw operates to move the distal segment of the distal sheath distally to uncover the compartment and deploy the heart valve.

Abstract: A delivery device for a prosthetic mitral valve includes five sheaths and a handle. The first sheath is coupled to a first handle portion and is rotatable and bendable. The second sheath is coupled to a second handle portion and extends through the first sheath. The second sheath is bendable, rotatable and translatable relative to the first sheath. The third sheath is coupled to a third handle portion and extends through the first and second sheaths. The third sheath is translatable relative to the second sheath. The second handle portion is coupled to the first and third handle portions. The fourth sheath extends through the third sheath and forms part of a compartment to store the prosthetic valve. The fifth sheath extends through the fourth sheath to a tip and is coupled to a retaining sheath that closes the compartment to retain the valve in a collapsed condition.

Abstract: An embolic protection device includes an outer surface that is configured to form a substantially sealed relationship with a body lumen such that emboli are deflected and/or captured by the outer surface before such emboli can travel to other parts of the body. An inner surface of the embolic protection device includes a longitudinally extending lumen through which instrumentation may be inserted, facilitating passage of such instrumentation through the body lumen while minimizing risk to the patient from emboli.

Abstract: A prosthetic heart valve having an inflow end and an outflow end includes a stent having a collapsed condition, an expanded condition, and cells arranged in circumferential rows. The stent has an anterior side configured to be disposed adjacent an anterior native valve leaflet and a posterior side configured to be disposed adjacent a posterior native valve leaflet. A valve assembly having a plurality of leaflets is disposed within the stent and a flange is disposed about the stent. The flange includes a flared portion adjacent the inflow end and a body portion extending from the flared portion to the outflow end, the flange extending between a first set of attachment points adjacent the inflow end, and a second set of attachment points adjacent the outflow end.