Abstract: A transcatheter valve prosthesis includes a stent and a prosthetic valve disposed within the stent. The stent is balloon expandable and includes an inflow portion, an outflow portion, and a transition portion extending between the inflow portion and the outflow portion. A diameter of an inflow end of the transcatheter valve prosthesis is greater than a diameter of an outflow end of the transcatheter valve prosthesis. The transcatheter valve prosthesis has a tapered profile along an entire height thereof when in the stent is in the expanded configuration. The inflow end of the transcatheter valve prosthesis is configured to sit within and contact an aortic annulus of the native aortic valve and the outflow end of the transcatheter valve prosthesis being configured to float within an ascending aorta without contacting the ascending aorta due to the tapered profile of the transcatheter valve prosthesis.

Abstract: Devices for, and methods of, compressing a stented prosthetic heart valve are disclosed. The method including inserting a stented prosthetic heart valve having a self-expandable stent frame into a container, initiating a cooling element in the container, transferring heat through a thermal conductor to cool an interior of the container, reducing a temperature of the self-expandable stent frame while located within the container to a critical temperature of not greater than 8° C., and compressing an outer diameter of the stented prosthetic heart valve while the stented prosthetic heart valve is at the critical temperature.

Abstract: A transcatheter valve prosthesis includes a balloon expandable stent and a prosthetic valve. An inflow portion of the stent includes a plurality of crowns and a plurality of struts with each crown being formed between a pair of opposing struts. Endmost inflow side openings and endmost inflow crowns are formed at the inflow end of the stent and the inflow end of the stent has a total of twelve endmost inflow crowns. An outflow portion of the stent includes a plurality of crowns and a plurality of struts with each crown being formed between a pair of opposing struts. Endmost outflow crowns are formed at the outflow end of the stent and the outflow end of the stent has a total of six endmost outflow crowns. The prosthetic valve is disposed within and secured to the stent.

Abstract: Devices for, and methods of, compressing a stented prosthetic heart valve are disclosed. The method including inserting a stented prosthetic heart valve having a self-expandable stent frame into a container, initiating a cooling element in the container, transferring heat through a thermal conductor to cool an interior of the container, reducing a temperature of the self-expandable stent frame while located within the container to a critical temperature of not greater than 8° C., and compressing an outer diameter of the stented prosthetic heart valve while the stented prosthetic heart valve is at the critical temperature.

Abstract: A “dry” packaging in which a prosthetic heart valve is packaged within a container with hydrogel that can be provided in many forms. Certain embodiments include hydrogel that is preloaded with glycerol or the like. The hydrogel regulates the humidity within the container through a diffusion-driven mechanism if a gradient of humidity between the inside and the outside of the hydrogel exists. Humidity regulation is important to prevent the tissue of the valve structure from drying out. When the partially-hydrated hydrogel is present within container, which is saturated with air of a predefined humidity, the water molecules from the air will be absorbed by the hydrogel if the air humidity is high (i.e. when the thermodynamics favor hydrogel hydration) or vice versa. Various embodiments are configured to also house at least a portion of a delivery device for delivering the prosthetic heart valve.

Abstract: Methods of compressing a stented prosthetic heart valve are disclosed. The method including inserting a stented prosthetic heart valve having a self-expandable stent frame into a container, initiating a cooling element in the container, transferring heat through a thermal conductor to cool an interior of the container, reducing a temperature of the self-expandable stent frame while located within the container to a critical temperature of not greater than 8° C., and compressing an outer diameter of the stented prosthetic heart valve while the stented prosthetic heart valve is at the critical temperature.

Abstract: A “dry” packaging in which a prosthetic heart valve is packaged within a container with hydrogel that can be provided in many forms. Certain embodiments include hydrogel that is preloaded with glycerol or the like. The hydrogel regulates the humidity within the container through a diffusion-driven mechanism if a gradient of humidity between the inside and the outside of the hydrogel exists. Humidity regulation is important to prevent the tissue of the valve structure from drying out. When the partially-hydrated hydrogel is present within container, which is saturated with air of a predefined humidity, the water molecules from the air will be absorbed by the hydrogel if the air humidity is high (i.e. when the thermodynamics favor hydrogel hydration) or vice versa. Various embodiments are configured to also house at least a portion of a delivery device for delivering the prosthetic heart valve.

Abstract: A transcatheter valve prosthesis includes a stent and a prosthetic valve. The stent includes an inflow portion, an outflow portion, and a transition portion extending between the inflow portion and the outflow portion. The transition portion includes a plurality of axial frame members, and three of the plurality of the axial frame members are commissure posts. At least two of the plurality of the axial frame members are commissure posts having a first end connected to a crown of the inflow portion and an unattached second end disposed within the outflow portion such that a pair of struts of the outflow portion intersect each commissure post at a mid-portion thereof. The prosthetic valve is configured to substantially block blood flow in one direction to regulate blood flow through a central lumen of the stent.

Abstract: A “dry” packaging in which a prosthetic heart valve is packaged within a container with hydrogel that can be provided in many forms. Certain embodiments include hydrogel that is preloaded with glycerol or the like. The hydrogel regulates the humidity within the container through a diffusion-driven mechanism if a gradient of humidity between the inside and the outside of the hydrogel exists. Humidity regulation is important to prevent the tissue of the valve structure from drying out. When the partially-hydrated hydrogel is present within container, which is saturated with air of a predefined humidity, the water molecules from the air will be absorbed by the hydrogel if the air humidity is high (i.e. when the thermodynamics favor hydrogel hydration) or vice versa. Various embodiments are configured to also house at least a portion of a delivery device for delivering the prosthetic heart valve.

Abstract: A “dry” packaging in which a prosthetic heart valve is packaged within a container with hydrogel that can be provided in many forms. Certain embodiments include hydrogel that is preloaded with glycerol or the like. The hydrogel regulates the humidity within the container through a diffusion-driven mechanism if a gradient of humidity between the inside and the outside of the hydrogel exists. Humidity regulation is important to prevent the tissue of the valve structure from drying out. When the partially-hydrated hydrogel is present within container, which is saturated with air of a predefined humidity, the water molecules from the air will be absorbed by the hydrogel if the air humidity is high (i.e. when the thermodynamics favor hydrogel hydration) or vice versa. Various embodiments are configured to also house at least a portion of a delivery device for delivering the prosthetic heart valve.

Abstract: A transcatheter valve prosthesis includes a stent and a prosthetic valve disposed within the stent. The stent is balloon expandable and includes an inflow portion, an outflow portion, and a transition portion extending between the inflow portion and the outflow portion. A diameter of an inflow end of the transcatheter valve prosthesis is greater than a diameter of an outflow end of the transcatheter valve prosthesis. The transcatheter valve prosthesis has a tapered profile along an entire height thereof when in the stent is in the expanded configuration. The inflow end of the transcatheter valve prosthesis is configured to sit within and contact an aortic annulus of the native aortic valve and the outflow end of the transcatheter valve prosthesis being configured to float within an ascending aorta without contacting the ascending aorta due to the tapered profile of the transcatheter valve prosthesis.

Abstract: A transcatheter valve prosthesis includes a stent, a prosthetic valve component disposed within and secured to the stent, and a sealing component. The sealing component includes a donut-shaped component and at least one pulling suture extending between the donut-shaped component and the stent. The at least one pulling suture is coupled to the stent such that the pulling suture can slide relative to the stent when the stent radially expands from the compressed configuration to the expanded configuration. The sealing component has a delivery configuration in which the donut-shaped component is disposed proximal of a proximal end of the stent and a deployed configuration in which the donut-shaped component is disposed distal of the proximal end of the stent. The pulling suture is configured to longitudinally pull the donut-shaped component as the stent radially expands from the compressed configuration to the expanded configuration.

Abstract: A transcatheter valve prosthesis includes a balloon expandable stent and a prosthetic valve. An inflow portion of the stent includes a plurality of crowns and a plurality of struts with each crown being formed between a pair of opposing struts. Endmost inflow side openings and endmost inflow crowns are formed at the inflow end of the stent and the inflow end of the stent has a total of twelve endmost inflow crowns. An outflow portion of the stent includes a plurality of crowns and a plurality of struts with each crown being formed between a pair of opposing struts. Endmost outflow crowns are formed at the outflow end of the stent and the outflow end of the stent has a total of six endmost outflow crowns. The prosthetic valve is disposed within and secured to the stent.

Abstract: Methods of compressing a stented prosthetic heart valve are disclosed. The method including inserting a stented prosthetic heart valve having a self-expandable stent frame into a container, initiating a cooling element in the container, transferring heat through a thermal conductor to cool an interior of the container, reducing a temperature of the self-expandable stent frame while located within the container to a critical temperature of not greater than 8° C., and compressing an outer diameter of the stented prosthetic heart valve while the stented prosthetic heart valve is at the critical temperature.

Abstract: Conditioned bioprosthetic tissues for forming prosthetic valves including a sheet of bioprosthetic tissue having a first major surface and a second major surface. The first major surface has a pattern including at least one depressed region and areas of relief adjacent to the at least one depressed region. The at least one depressed region has a first tissue density that is greater than a second tissue density of the areas of relief.

Abstract: Methods of compressing a stented prosthetic heart valve are disclosed. The method including inserting a stented prosthetic heart valve having a self-expandable stent frame into a container, initiating a cooling element in the container, transferring heat through a thermal conductor to cool an interior of the container, reducing a temperature of the self-expandable stent frame while located within the container to a critical temperature of not greater than 8° C., and compressing an outer diameter of the stented prosthetic heart valve while the stented prosthetic heart valve is at the critical temperature.

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 method of reinforcing or repairing a bioprosthetic tissue for use as a prosthetic valve leaflet. The method includes evaluating a bioprosthetic tissue, identifying a defect in the bioprosthetic tissue, and selectively applying an adhesive to a surface of the bioprosthetic tissue at the defect prior to implantation in a patient.

Abstract: Methods of compressing a stented prosthetic heart valve are disclosed. The method including inserting a stented prosthetic heart valve having a self-expandable stent frame into a container, initiating a cooling element in the container, transferring heat through a thermal conductor to cool an interior of the container, reducing a temperature of the self-expandable stent frame while located within the container to a critical temperature of not greater than 8° C., and compressing an outer diameter of the stented prosthetic heart valve while the stented prosthetic heart valve is at the critical temperature.

Abstract: A “dry” packaging in which a prosthetic heart valve is packaged within a container with hydrogel that can be provided in many forms. Certain embodiments include hydrogel that is preloaded with glycerol or the like. The hydrogel regulates the humidity within the container through a diffusion-driven mechanism if a gradient of humidity between the inside and the outside of the hydrogel exists. Humidity regulation is important to prevent the tissue of the valve structure from drying out. When the partially-hydrated hydrogel is present within container, which is saturated with air of a predefined humidity, the water molecules from the air will be absorbed by the hydrogel if the air humidity is high (i.e. when the thermodynamics favor hydrogel hydration) or vice versa. Various embodiments are configured to also house at least a portion of a delivery device for delivering the prosthetic heart valve.