Abstract: A prosthesis for implantation at a native semilunar valve site of a subject can include a support structure configured such that in a first rotational disposition of the prosthesis with respect to the native semilunar valve, a tactile feedback sensation is provided to a user implanting the prosthesis.

Abstract: A prosthesis for implantation at a native semilunar valve site of a subject can include a support structure configured such that in a first rotational disposition of the prosthesis with respect to the native semilunar valve, a tactile feedback sensation is provided to a user implanting the prosthesis.

Abstract: A device useful for implantation at a native heart valve can include an anchor element having a tubular configuration defining a longitudinal direction and a circumference, a heart valve prosthesis disposed within the anchor element, and a plurality of elongate members positioned at equidistant angular intervals about the circumference of the anchor element. The device can be configured to be transitioned from a radially collapsed delivery configuration to a radially expanded implantation configuration, and the plurality of elongate members can have a length extending in the longitudinal direction of the tubular member in the expanded implantation configuration.

Abstract: A device useful for implantation at a native heart valve can include an anchor element having a tubular configuration defining a longitudinal direction and a circumference, a heart valve prosthesis disposed within the anchor element, and a plurality of elongate members positioned at equidistant angular intervals about the circumference of the anchor element. The device can be configured to be transitioned from a radially collapsed delivery configuration to a radially expanded implantation configuration, and the plurality of elongate members can have a length extending in the longitudinal direction of the tubular member in the expanded implantation configuration.

Abstract: Devices and methods for preparing a transcatheter heart valve system. The device includes a housing, sealing apparatuses and a port. The housing forms a chamber sized to receive a prosthetic valve and a portion of a delivery device. During use, the prosthesis is seated in the chamber, and the sealing apparatuses operated to seal the chamber about the delivery device. Air bubbles in a liquid delivered through the delivery device and to the chamber are removed from the system via the port, thereby flushing the system. Further, the device is manipulated to permit loading of the prosthesis into the delivery device in an air bubble-free environment.

Abstract: A stented prosthetic heart valve including a stent, a plurality of leaflets, and a coupling apparatus. The stent includes a plurality of struts combining to define a generally tubular body, with the struts forming strut segments. The leaflets are mounted to the stent, and include a leaflet provided as part of a first leaflet layer that further forms a tab region. The coupling apparatus is configured for connecting the first leaflet layer to the stent, and includes a backing layer, a guide plate, and a pin. The guide plate and the pin are formed apart from the stent. In this regard, a portion of the backing layer and the tab region are secured between the guide plate and the pin. Further, another portion of the backing layer is attached to at least one of the strut segments to mount the leaflet of the first leaflet layer to the stent.

Abstract: The delivery systems disclosed herein can create simultaneous movement of an inner and an outer sheath of the delivery system. The delivery systems can generally include a handle assembly and a delivery catheter. In certain embodiments, the inner shaft and the outer sheath can be slidably controlled by a control element in the handle. The handle assembly can include a housing with a thumbwheel acting as the control element. In certain embodiments, movement of the inner shaft and the outer sheath can be caused via a gear-type system. In certain embodiments, the handle assembly can include a rotatable housing. A control element can rotate the housing, which can cause a first boss associated with the outer sheath and a second boss associated with the inner shaft to move in opposite directions.

Abstract: Medical devices and methods for closing an anatomical aperture in a tissue are disclosed. The medical devices can include distal and proximal support structures, which can include a plurality of anchor members. A connection element can connect the distal and proximal support structures, and be configured to twist to create a seal within the medical device. In certain embodiments, a sheath about the medical device can be retracted to expose the distal support structure, which can allow it to revert to an anchoring configuration from a delivery configuration, such that the anchor members can engage an interior surface of the tissue. After twisting the connection element to form a seal, the sheath can be further retracted to expose the proximal support structure, which can allow it to revert to an anchoring configuration from a delivery configuration, such that the anchor members can engage an exterior surface of the tissue.

Abstract: A valve prosthesis and methods for implanting the prosthesis are provided. The prosthesis generally includes a self-expanding frame and two or more engagement arms. A valve prosthesis is sutured to the self-expanding frame. Each engagement arm corresponds to a native mitral valve leaflet. At least one engagement arm immobilizes the native leaflets, and holds the native leaflets close to the main frame. The prosthetic mitral valve frame also includes two or more anchor attachment points. Each anchor attachment point is attached to one or more anchors that help attach the valve prosthesis to the heart.

Abstract: A device useful for implantation at a native heart valve can include an anchor element having a tubular configuration defining a longitudinal direction and a circumference, a heart valve prosthesis disposed within the anchor element, and a plurality of elongate members positioned at equidistant angular intervals about the circumference of the anchor element. The device can be configured to be transitioned from a radially collapsed delivery configuration to a radially expanded implantation configuration, and the plurality of elongate members can have a length extending in the longitudinal direction of the tubular member in the expanded implantation configuration.

Abstract: A device useful for implantation at a native heart valve can include an anchor element having a tubular configuration defining a longitudinal direction and a circumference, a heart valve prosthesis disposed within the anchor element, and a plurality of elongate members positioned at equidistant angular intervals about the circumference of the anchor element. The device can be configured to be transitioned from a radially collapsed delivery configuration to a radially expanded implantation configuration, and the plurality of elongate members can have a length extending in the longitudinal direction of the tubular member in the expanded implantation configuration.

Abstract: A dual valve prosthesis having first and second prosthetic valve sections is disclosed. The first prosthetic valve section includes a stent structure with a first prosthetic valve secured therein and the second prosthetic valve section includes an annular frame with a second prosthetic valve secured therein. When the dual valve prosthesis is in an expanded configuration, the annular frame extends from the stent structure such that the first and second prosthetic valves are laterally offset from each other. In a method in accordance herewith, the first and second prosthetic valve sections include prosthetic aortic and mitral valves, respectively, and the dual heart valve prosthesis is configured to replace both the native aortic and mitral valves of the heart in a single transcatheter heart valve implantation procedure.

Abstract: Devices and methods for preparing a transcatheter heart valve system. The device includes a housing, sealing apparatuses and a port. The housing forms a chamber sized to receive a prosthetic valve and a portion of a delivery device. During use, the prosthesis is seated in the chamber, and the sealing apparatuses operated to seal the chamber about the delivery device. Air bubbles in a liquid delivered through the delivery device and to the chamber are removed from the system via the port, thereby flushing the system. Further, the device is manipulated to permit loading of the prosthesis into the delivery device in an air bubble-free environment.

Abstract: The delivery systems disclosed herein can create simultaneous movement of an inner and an outer sheath of the delivery system. The delivery systems can generally include a handle assembly and a delivery catheter. In certain embodiments, the inner shaft and the outer sheath can be slidably controlled by a control element in the handle. The handle assembly can include a housing with a thumbwheel acting as the control element. In certain embodiments, movement of the inner shaft and the outer sheath can be caused via a gear-type system. In certain embodiments, the handle assembly can include a rotatable housing. A control element can rotate the housing, which can cause a first boss associated with the outer sheath and a second boss associated with the inner shaft to move in opposite directions.

Abstract: A valve prosthesis and methods for implanting the prosthesis are provided. The prosthesis generally includes a self-expanding frame and two or more engagement arms. A valve prosthesis is sutured to the self-expanding frame. Each engagement arm corresponds to a native mitral valve leaflet. At least one engagement arm immobilizes the native leaflets, and holds the native leaflets close to the main frame. The prosthetic mitral valve frame also includes two or more anchor attachment points. Each anchor attachment point is attached to one or more anchors that help attach the valve prosthesis to the heart.

Abstract: Medical devices and methods for closing an anatomical aperture in a tissue are disclosed. The medical devices can include distal and proximal support structures, which can include a plurality of anchor members. A connection element can connect the distal and proximal support structures, and be configured to twist to create a seal within the medical device. In certain embodiments, a sheath about the medical device can be retracted to expose the distal support structure, which can allow it to revert to an anchoring configuration from a delivery configuration, such that the anchor members can engage an interior surface of the tissue. After twisting the connection element to form a seal, the sheath can be further retracted to expose the proximal support structure, which can allow it to revert to an anchoring configuration from a delivery configuration, such that the anchor members can engage an exterior surface of the tissue.

Abstract: A prosthesis having first and second prosthetic sections is disclosed. The first prosthetic section includes a stent structure that may contain a first prosthetic valve secured therein and the second prosthetic section includes an annular frame that may contain a second prosthetic valve secured therein. When the prosthesis is in an expanded configuration, the annular frame extends from the stent structure such that the first and second prosthetic sections are laterally offset from each other. In a method in accordance herewith, the first and second prosthetic sections may include prosthetic aortic and mitral valves, respectively, and the heart valve prosthesis is configured to replace one or both of the native aortic and mitral valves of the heart in a single transcatheter heart valve implantation procedure.

Abstract: An integrated balloon dilation and valve prosthesis delivery device is provided having a capsule that is configured to surround a collapsed valve prosthesis and that contains a balloon on an exterior surface.

Abstract: Heart valve delivery systems and methods of delivering and implanting heart valves using delivery catheters are disclosed. The delivery systems can include a handle assembly with a rotatable control knob and a catheter including an introducer shaft, an intermediate shaft extending from the handle assembly, an inner shaft extending from the handle assembly, and a capsule for containing a prosthesis. The distal end of the capsule can be connected to a distal end of the inner shaft, which can be moved in a distal direction by the rotatable control knob to deploy the prosthesis. By advancing the introducer through the deployed prosthesis and retracting the capsule to mate with the introducer, a smooth profile can be created for retraction of the system through the deployed prosthesis, minimizing hang-ups and snagging.

Abstract: Prosthetic valve introducer systems and methods for deploying a heart valve prosthesis within a body lumen are disclosed. In certain embodiments, the valve introducer can include a delivery shaft to house a prosthetic valve and a distal tip, and a deployment element to push a prosthetic valve out of the distal tip of the delivery shaft. The valve introducer can include at least one finger gripping element. The delivery shaft can be inserted into a body lumen and advanced to a desired deployment location. In certain embodiments, the prosthetic valve can be deployed by pushing the deployment element in a distal direction, thereby pushing the prosthetic valve out of the distal tip of the delivery shaft.