Abstract: Prosthetic valve devices for implantation within a body or lumen that are configured for hemodynamic monitoring. The prosthetic valve device includes one or more sensors in electrical communication with an inductor formed by a portion of the frame or coupled to the frame of the prosthetic valve device. The sensor is configured to measure a flow parameter within the prosthesis. The inductor is configured to relay a signal to an external detector, the signal being associated with the flow parameter measured by the sensor.

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: A prosthesis includes a tubular graft, a prosthetic valve component, an inflow stent, an outflow stent, and a plurality of body stents disposed between the inflow and outflow stents. Each stent is a sinusoidal patterned radially-expandable ring having a first set of crowns and a second set of crowns, with the first set of crowns disposed closer to an inflow end of the tubular graft than the second set of crowns. The prosthesis is configured to be resistant to backfolding and/or buckling during deployment thereof.

Abstract: A prosthesis includes a tubular graft, a prosthetic valve component, an inflow stent, an outflow stent, and a plurality of body stents disposed between the inflow and outflow stents. Each stent is a sinusoidal patterned radially-expandable ring having a first set of crowns and a second set of crowns, with the first set of crowns disposed closer to an inflow end of the tubular graft than the second set of crowns. The prosthesis is configured to be resistant to backfolding and/or buckling during deployment thereof.

Abstract: An integrated valve prosthesis includes an anchor stent, a tether component, and a valve component. The anchor stent includes a self-expanding tubular frame member configured to be deployed in the annulus of an aortic valve or the aorta. The valve component includes a valve frame and a prosthetic valve coupled to the valve frame, and is configured to be deployed within the anchor stent. The tether component includes a first end coupled to the anchor stent and a second end coupled to the valve frame. In the delivery configuration, the tether component extends in a first direction from the anchor stent to the valve component, and in the deployed configuration, the tether component extends in a second direction from the anchor stent to the valve component. The second direction is generally opposite the first direction. The tether component may set the location of the valve component relative to the anchor stent.

Abstract: An integrated valve prosthesis includes an anchor stent, a tether component, and a valve component. The anchor stent includes a self-expanding tubular frame member configured to be deployed in the annulus of an aortic valve or the aorta. The valve component includes a valve frame and a prosthetic valve coupled to the valve frame, and is configured to be deployed within the anchor stent. The tether component includes a first end coupled to the anchor stent and a second end coupled to the valve frame. In the delivery configuration, the tether component extends in a first direction from the anchor stent to the valve component, and in the deployed configuration, the tether component extends in a second direction from the anchor stent to the valve component. The second direction is generally opposite the first direction. The tether component may set the location of the valve component relative to the anchor stent.

Abstract: A prosthesis includes a tubular graft, a prosthetic valve component, an inflow stent, an outflow stent, and a plurality of body stents disposed between the inflow and outflow stents. Each stent is a sinusoidal patterned radially-expandable ring having a first set of crowns and a second set of crowns, with the first set of crowns disposed closer to an inflow end of the tubular graft than the second set of crowns. The prosthesis is configured to be resistant to backfolding and/or buckling during deployment thereof.

Abstract: An example method includes receiving, via at least one processor, anatomical measurements of a lumen of a patient. The method includes performing, via the at least one processor, a geometrical fit analysis based on the anatomical measurements to identify potential prostheses to be implanted in the lumen and an optimal implantation landing zone within the lumen for at least one of the potential prostheses, wherein the geometrical fit analysis includes comparing a geometry of the lumen, including shape factors for the lumen, to geometries of a plurality of candidate prostheses at a plurality of potential implant deployment positions within the lumen. The method includes performing, via the at least one processor, a biomechanical interaction analysis to select one of the identified potential prostheses based on a risk of migration within the lumen of each of the identified potential prostheses.

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 of transcatheter delivery of a prosthetic heart valve. A distal region of a guide member assembly is advanced into a heart of a patient. The distal region is docked to native anatomy of the heart. A delivery device, including a collapsed prosthetic heart valve, is advanced over the docked guide member assembly. The collapsed prosthetic heart valve is located at an implantation site. The prosthetic heart valve is deployed from the delivery device, and then the delivery device is removed from the patient. At least a portion of the guide member assembly is removed from the patient. In some embodiments, the docking structure is docked to one or more of native mitral valve leaflets, chordae in the left ventricle, or walls of the left ventricle as part of a transseptal mitral valve delivery procedure.

Abstract: Methods of transcatheter delivery of a prosthetic heart valve. A distal region of a guide member assembly is advanced into a heart of a patient. The distal region is docked to native anatomy of the heart. A delivery device, including a collapsed prosthetic heart valve, is advanced over the docked guide member assembly. The collapsed prosthetic heart valve is located at an implantation site. The prosthetic heart valve is deployed from the delivery device, and then the delivery device is removed from the patient. At least a portion of the guide member assembly is removed from the patient. In some embodiments, the docking structure is docked to one or more of native mitral valve leaflets, chordae in the left ventricle, or walls of the left ventricle as part of a transseptal mitral valve delivery procedure.

Abstract: An integrated valve prosthesis includes an anchor stent, a tether component, and a valve component. The anchor stent includes a self-expanding tubular frame member configured to be deployed in the annulus of an aortic valve or the aorta. The valve component includes a valve frame and a prosthetic valve coupled to the valve frame, and is configured to be deployed within the anchor stent. The tether component includes a first end coupled to the anchor stent and a second end coupled to the valve frame. In the delivery configuration, the tether component extends in a first direction from the anchor stent to the valve component, and in the deployed configuration, the tether component extends in a second direction from the anchor stent to the valve component. The second direction is generally opposite the first direction. The tether component may set the location of the valve component relative to the anchor stent.

Abstract: An integrated valve prosthesis includes an anchor stent, a tether component, and a valve component. The anchor stent includes a self-expanding tubular frame member configured to be deployed in the annulus of an aortic valve or the aorta. The valve component includes a valve frame and a prosthetic valve coupled to the valve frame, and is configured to be deployed within the anchor stent. The tether component includes a first end coupled to the anchor stent and a second end coupled to the valve frame. In the delivery configuration, the tether component extends in a first direction from the anchor stent to the valve component, and in the deployed configuration, the tether component extends in a second direction from the anchor stent to the valve component. The second direction is generally opposite the first direction. The tether component may set the location of the valve component relative to the anchor stent.

Abstract: A tool for compressing a stented prosthesis. The tool includes first and second sets of rollers. The first set includes a plurality of rollers arranged to define a first working region having a first working diameter. The second set includes a plurality of rollers arranged to define a second working region having a second working diameter. The sets of rollers are arranged such that the working regions are axially aligned. The first working diameter is greater than the second working diameter. A stented prosthesis traversing the first working region and then the second working region is forced to a compressed state. In some embodiments, the tool includes one or more intermediate sets of rollers between the first and second sets of rollers, with each of the intermediate sets of rollers defining a working region having a working diameter. The respective working diameters progressively decrease in a downstream direction.

Abstract: Methods of transcatheter delivery of a prosthetic heart valve. A distal region of a guide member assembly is advanced into a heart of a patient. The distal region is docked to native anatomy of the heart. A delivery device, including a collapsed prosthetic heart valve, is advanced over the docked guide member assembly. The collapsed prosthetic heart valve is located at an implantation site. The prosthetic heart valve is deployed from the delivery device, and then the delivery device is removed from the patient. At least a portion of the guide member assembly is removed from the patient. In some embodiments, the docking structure is docked to one or more of native mitral valve leaflets, chordae in the left ventricle, or walls of the left ventricle as part of a transseptal mitral valve delivery procedure.

Abstract: Aspects of the disclosure include sizing catheters and methods for determining the size and other physical parameters of an internal orifice or lumen. Embodiments include a sizing catheter assembly having a handle assembly and a catheter assembly including at least one catheter extending from the handle assembly. The catheter assembly also includes at least two sizers, which can be adjustably spaced from each other. Each of the sizers are configured to conform to respective portions of a lumen of a patient's anatomy. The sizing catheter is configured such that the sizers are configured to specify or determine first and second dimensions of the lumen and also distance between the sizers. The sizers can include valve leaflets or the sizing catheter can include a temporary valve. Additional aspects include software/methods of assessing and determining an appropriate implantable device that can include assessing the biomechanical interaction between the device and the anatomy.

Abstract: A tool for compressing a stented prosthesis. The tool includes first and second sets of rollers. The first set includes a plurality of rollers arranged to define a first working region having a first working diameter. The second set includes a plurality of rollers arranged to define a second working region having a second working diameter. The sets of rollers are arranged such that the working regions are axially aligned. The first working diameter is greater than the second working diameter. A stented prosthesis traversing the first working region and then the second working region is forced to a compressed state. In some embodiments, the tool includes one or more intermediate sets of rollers between the first and second sets of rollers, with each of the intermediate sets of rollers defining a working region having a working diameter. The respective working diameters progressively decrease in a downstream direction.

Abstract: An integrated valve prosthesis includes an anchor stent, a tether component, and a valve component. The anchor stent includes a self-expanding tubular frame member configured to be deployed in the annulus of an aortic valve or the aorta. The valve component includes a valve frame and a prosthetic valve coupled to the valve frame, and is configured to be deployed within the anchor stent. The tether component includes a first end coupled to the anchor stent and a second end coupled to the valve frame. In the delivery configuration, the tether component extends in a first direction from the anchor stent to the valve component, and in the deployed configuration, the tether component extends in a second direction from the anchor stent to the valve component. The second direction is generally opposite the first direction. The tether component may set the location of the valve component relative to the anchor stent.

Abstract: Aspects of the disclosure include sizing catheters and methods for determining the size and other physical parameters of an internal orifice or lumen. Embodiments include a sizing catheter assembly having a handle assembly and a catheter assembly including at least one catheter extending from the handle assembly. The catheter assembly also includes at least two sizers, which can be adjustably spaced from each other. Each of the sizers are configured to conform to respective portions of a lumen of a patient's anatomy. The sizing catheter is configured such that the sizers are configured to specify or determine first and second dimensions of the lumen and also distance between the sizers. The sizers can include valve leaflets or the sizing catheter can include a temporary valve. Additional aspects include software/methods of assessing and determining an appropriate implantable device that can include assessing the biomechanical interaction between the device and the anatomy.