Abstract: Delivery devices for delivering a stented prosthesis to a target site are disclosed. Certain disclosed delivery devices include a handle assembly including an actuator, a shaft assembly interconnected to the handle assembly, and are configured to releasably retain the stented prosthesis to the delivery device with at least one elongate tension member. The delivery devices further include a torque shaft that is configured to apply and adjust the amount of tension in the each tension member. For example, the torque shaft can be configured to wind and unwind each elongate tension member around the torque shaft to correspondingly compress and expand the stented prosthesis. The torque shaft can be controlled with an actuator provided in the handle assembly, for example. In some embodiments, the actuator is further configured to axially move the torque shaft.

Abstract: Delivery devices for delivering a stented prosthesis to a target site are disclosed. Certain disclosed delivery devices include a handle assembly including an actuator, a shaft assembly interconnected to the handle assembly, and are configured to releasably retain the stented prosthesis to the delivery device with at least one elongate tension member. The delivery devices further include a torque shaft that is configured to apply and adjust the amount of tension in the each tension member. For example, the torque shaft can be configured to wind and unwind each elongate tension member around the torque shaft to correspondingly compress and expand the stented prosthesis. The torque shaft can be controlled with an actuator provided in the handle assembly, for example. In some embodiments, the actuator is further configured to axially move the torque shaft.

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 system includes an inflow loading assembly configured to compress an inflow portion of the implantable medical device as the implantable medical device is advanced through the inflow loading assembly. The system also includes an outflow loading assembly removably coupled to the inflow loading assembly. The outflow loading assembly is configured to partially compress an outflow portion of the implantable medical device during coupling to the inflow loading assembly. The inflow loading assembly includes one or more biasing features that are configured to asymmetrically compress the inflow portion of the implantable medical device.

Abstract: Aspects of the disclosure include apparatuses for and methods of removing a ligation clip interconnecting two mitral valve leaflets. Methods can include providing a mitral valve having first and second valve leaflets interconnected with a ligation clip. The ligation clip includes a base supporting a first and second retaining arms each having an end opposite the base. The first and second valve leaflets are compressed between the first and second retaining arms. The methods further include physically separating the ligation clip from both of the first and second leaflets with the apparatus, which is configured to dislodge the first and second leaflets from the ligation clip. The apparatuses are further configured to withdraw the ligation clip from the patient along with the apparatus.

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: Delivery devices for delivering a stented prosthesis to a target site are disclosed. Certain disclosed delivery devices include a handle assembly including an actuator, a shaft assembly interconnected to the handle assembly, and are configured to releasably retain the stented prosthesis to the delivery device with at least one elongate tension member. The delivery devices further include a torque shaft that is configured to apply and adjust the amount of tension in the each tension member. For example, the torque shaft can be configured to wind and unwind each elongate tension member around the torque shaft to correspondingly compress and expand the stented prosthesis. The torque shaft can be controlled with an actuator provided in the handle assembly, for example. In some embodiments, the actuator is further configured to axially move the torque shaft.

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: Delivery devices for delivering a stented prosthesis to a target site are disclosed. Certain disclosed delivery devices include a handle assembly including an actuator, a shaft assembly interconnected to the handle assembly, and are configured to releasably retain the stented prosthesis to the delivery device with at least one elongate tension member. The delivery devices further include a torque shaft that is configured to apply and adjust the amount of tension in the each tension member. For example, the torque shaft can be configured to wind and unwind each elongate tension member around the torque shaft to correspondingly compress and expand the stented prosthesis. The torque shaft can be controlled with an actuator provided in the handle assembly, for example. In some embodiments, the actuator is further configured to axially move the torque shaft.

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: 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 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: Delivery devices for delivering a stented prosthesis to a target site are disclosed. Certain disclosed delivery devices include a handle assembly including an actuator, a shaft assembly interconnected to the handle assembly, and are configured to releasably retain the stented prosthesis to the delivery device with at least one elongate tension member. The delivery devices further include a torque shaft that is configured to apply and adjust the amount of tension in the each tension member. For example, the torque shaft can be configured to wind and unwind each elongate tension member around the torque shaft to correspondingly compress and expand the stented prosthesis. The torque shaft can be controlled with an actuator provided in the handle assembly, for example. In some embodiments, the actuator is further configured to axially move the torque shaft.

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.