Abstract: A heart valve therapy system including a delivery device and a stented valve. The delivery device includes an outer sheath, an inner shaft, an optional hub assembly, and a plurality of tethers. In a delivery state, a stent frame of the prosthesis is crimped over the inner shaft and maintained in a compressed condition by the outer sheath. The tethers are connected to the stent frame. In a partial deployment state, the outer sheath is at least partially withdrawn, allowing the stent frame to self-expand. Tension in the tethers prevents the stent frame from rapidly expanding and optionally allowing recapture. Upon completion of the stent frame expansion, the tethers are withdrawn.

Abstract: Support devices and associated systems and methods for releasably retaining a delivery system handle while delivering a medical device to a target within a human are described herein. The support device is configured to engage the delivery system handle and enable a user to maneuver a distal end portion of the delivery system by manipulating features of the support device.

Abstract: Systems for delivering prosthetic heart valve devices can include, for example, an elongated catheter body, a deliver capsule carried by the catheter body, and an expandable atraumatic member. The delivery capsule includes a platform and a housing having an outer wall and a proximal rim, and the platform is configured to be releasably coupled to a prosthetic heart valve device. The housing is configured to slide along the platform from a containment configuration to a deployment configuration. The expandable atraumatic member has an atraumatic surface and a peripheral portion. The atraumatic member has a compacted configuration and an expanded configuration in which the peripheral portion extends laterally outward over the proximal rim of the housing to protect tissue of the heart and the vasculature from potentially being damaged by the proximal rim of the housing as the delivery system is withdrawn in a proximal direction through the patient.

Abstract: A tool for use in loading a transcatheter valve prosthesis within a delivery catheter includes a body portion, a pivotable element and a biasing element. The body portion includes a central passageway extending form a proximal end to a distal end of the body portion. The central passageway is configured to receive a distal portion of a delivery catheter therethrough. The pivotable element is attached to the body portion and is configured to secure a tether during loading of a transcatheter valve prosthesis within the delivery catheter. The biasing element compresses the pivotable element against the body portion such that the pivotable element holds a second end against the delivery catheter and secures the tether thereto. The pivotable element may be two or more pivotable elements.

Abstract: A delivery system for delivering a heart valve prosthesis includes a heart valve prosthesis and a delivery catheter. The heart valve prosthesis includes an anchoring member and an inner valve support, and further includes a radially collapsed configuration and a radially expanded configuration. The delivery catheter includes a handle, an outer shaft, an intermediate shaft, an inner shaft, and a distal tip component. The delivery catheter further includes a delivery configuration. In the delivery configuration, the outer shaft of the delivery catheter is configured to retain a first portion of the anchoring member, the intermediate shaft is configured to retain a first portion of the inner valve support, and the distal tip component is configured to retain a second end of the anchoring member and a second end of the inner valve support each in a radially compressed state.

Abstract: A prosthesis having a radially expanded configuration and a radially compressed configuration includes a frame with a plurality of infolding longitudinal segments. Each of the infolding longitudinal segments of the frame extend an entire length of the frame and is configured to deform radially inward when the prosthesis is in the radially compressed configuration such that a series of longitudinally aligned apices of each infolding longitudinal segment is disposed radially inward of the remainder of the prosthesis. In an embodiment, the frame also includes a plurality of outfolding longitudinal segments. Each of the outfolding longitudinal segments of the frame extend an entire length of the frame and is configured to deform radially outward when the prosthesis is in the radially compressed configuration such that a series of longitudinally aligned apices of each outfolding longitudinal segment is disposed radially outward of the remainder of the prosthesis.

Abstract: Delivery systems with telescoping capsules for delivering prosthetic heart valve devices and associated methods are disclosed herein. A delivery system configured in accordance with embodiments of the present technology can include, for example, a delivery capsule having a first housing, a second housing slidably disposed within a portion of the first housing, and a prosthetic device constrained within the first and second housings. The delivery capsule can further include first and second chamber defined in part by the first and second housings. During deployment, fluid is delivered to the first chamber to move the first housing distally over the second housing, thereby releasing a portion of the prosthetic device. Subsequently, fluid is delivered to the second chamber such that the first and second housings move together in the distal direction to release a second portion of the prosthetic device.

Abstract: Methods of deploying and securing a heart valve prosthesis are disclosed. A heart valve prosthesis having a plurality of anchor guides is loaded within a catheter-based delivery device, wherein each of the anchor guides is releasably engaged by a respective elongate member and wherein tensioning of the elongate members aids in collapsing the prosthesis during loading. The delivery device is advanced via a transcatheter procedure to position the heart valve prosthesis at an implantation site. The heart valve prosthesis undergoes controlled deployment by controlling the release of tension on the elongate members. After deployment of the heart valve prosthesis, an anchor tool is advanced along at least one elongate guide member to the anchor guide associated therewith and positioned at a securement site. When the securement site is reached, an anchor clip is released from the anchor tool to secure the prosthesis to the heart.

Abstract: A prosthesis can include a collapsible, reexpandable frame comprising first, second, and third sets of struts that define first and second rows of expandable cells. In some embodiments, the struts of the first, second, and third set of struts can be tapered. In some embodiments, the frame can include an intermediate section and an inflow section that is proximal to the intermediate section. The inflow section can include a concave saddle portion that is adjacent the intermediate section, and an outwardly flared portion.

Abstract: A tool for use in loading a transcatheter valve prosthesis within a delivery catheter includes a body portion, a pivotable element and a biasing element. The body portion includes a central passageway extending form a proximal end to a distal end of the body portion. The central passageway is configured to receive a distal portion of a delivery catheter therethrough. The pivotable element is attached to the body portion and is configured to secure a tether during loading of a transcatheter valve prosthesis within the delivery catheter. The biasing element compresses the pivotable element against the body portion such that the pivotable element holds a second end against the delivery catheter and secures the tether thereto. The pivotable element may be two or more pivotable elements.

Abstract: Delivery systems with telescoping capsules for delivering prosthetic heart valve devices and associated methods are disclosed herein. A delivery system configured in accordance with embodiments of the present technology can include, for example, a delivery capsule having a first housing, a second housing slidably disposed within a portion of the first housing, and a prosthetic device constrained within the first and second housings. The delivery capsule can further include first and second chamber defined in part by the first and second housings. During deployment, fluid is delivered to the first chamber to move the first housing distally over the second housing, thereby releasing a portion of the prosthetic device. Subsequently, fluid is delivered to the second chamber such that the first and second housings move together in the distal direction to release a second portion of the prosthetic device.

Abstract: A prosthesis can include a collapsible, reexpandable frame having first, second, and third sets of struts that define first and second rows of expandable cells. In some embodiments, the struts of the first, second, and third set of struts can be tapered. In some embodiments, the frame can include an intermediate section and an inflow section that is proximal to the intermediate section. The inflow section can include a concave saddle portion that is adjacent the intermediate section, and an outwardly flared portion.

Abstract: Methods of deploying and securing a heart valve prosthesis are disclosed. A heart valve prosthesis (100) having a plurality of anchor guides (212) is loaded within a catheter-based delivery device, wherein each of the anchor guides is releasably engaged by a respective elongate member (338) and wherein tensioning of the elongate members aids in collapsing the prosthesis during loading. The delivery device is advanced via a transcatheter procedure to position the heart valve prosthesis at an implantation site. The heart valve prosthesis undergoes controlled deployment by controlling the release of tension on the elongate members. After deployment of the heart valve prosthesis, an anchor tool (660) is advanced along a guide member to the anchor guide positioned at a securement site. When the securement site is reached, an anchor clip (662) is released from the anchor tool to secure the prosthesis to the heart.

Abstract: A device for percutaneously delivering a stented prosthetic heart valve. The device includes an inner shaft assembly, a delivery sheath assembly, an outer stability tube, and a handle. The sheath assembly is slidably disposed over the inner shaft, and includes a capsule and a shaft. The capsule compressively contains the prosthesis over the inner shaft. The stability tube is slidably disposed over the delivery sheath, and includes a distal region configured to be radially expandable from a first shape having a first diameter to a second shape having a larger, second diameter. In a first delivery state, the distal region assumes the first shape, providing a low profile appropriate for traversing a patient's vasculature. In a second delivery state, the distal region has the expanded diameter second shape, sized to receive the capsule, such as when retracting the capsule to implant the prosthesis.

Abstract: Prosthetic heart valve devices and associated methods for percutaneous or transcatheter heart valve replacement are disclosed herein. A heart valve prosthesis configured in accordance herewith includes a frame having a valve support and a plurality of support arms extending therefrom. The plurality of support arms may include a main support arm configured to extend from the valve support for capturing at least a portion of a valve leaflet of a native heart valve therebetween when the valve prosthesis is in an expanded configuration and deployed within the native heart valve. In addition, the plurality of support arms may include multiple supplemental support arms disposed about the circumference of the valve support that when deployed in the expanded configuration are configured to at least partially engage subannular tissue at the native heart valve.

Abstract: A heart valve prosthesis and delivery systems are provided for replacing a cardiac valve. The heart valve prosthesis includes a self-expanding frame includes a portion having a crimp that provides additional flexibility to the self-expanding frame in the collapsed configuration.

Abstract: Prosthetic heart valve devices and associated methods for percutaneous or transcatheter heart valve replacement are disclosed herein. A heart valve prosthesis configured in accordance herewith includes a frame having a valve support and a plurality of support arms extending therefrom. The plurality of support arms may include a main support arm configured to extend from the valve support for capturing at least a portion of a valve leaflet of a native heart valve therebetween when the valve prosthesis is in an expanded configuration and deployed within the native heart valve. In addition, the plurality of support arms may include multiple supplemental support arms disposed about the circumference of the valve support that when deployed in the expanded configuration are configured to at least partially engage subannular tissue at the native heart valve.

Abstract: A transcatheter valve prosthesis including a tubular stent includes an interior skirt or skirt portion is coupled to and covers an inner circumferential surface of the stent, and an exterior skirt or skirt portion is coupled to and covers an outer circumferential surface of the stent. A prosthetic valve component is disposed within and secured to the interior skirt or skirt portion. The interior and exterior skirts or skirt portions may overlap to form a double layer of skirt material on the stent, or may be portions of a skirt that do not overlap such that only a single layer of skirt material covers the stent. When the stent is in at least the compressed configuration, at least one endmost crown may be positioned radially inwards with respect to the remaining endmost crowns formed at the inflow end of the stent in order to accommodate the exterior skirt.

Abstract: A transcatheter valve prosthesis including a tubular stent includes an interior skirt or skirt portion is coupled to and covers an inner circumferential surface of the stent, and an exterior skirt or skirt portion is coupled to and covers an outer circumferential surface of the stent. A prosthetic valve component is disposed within and secured to the interior skirt or skirt portion. The interior and exterior skirts or skirt portions may overlap to form a double layer of skirt material on the stent, or may be portions of a skirt that do not overlap such that only a single layer of skirt material covers the stent. When the stent is in at least the compressed configuration, at least one endmost crown may be positioned radially inwards with respect to the remaining endmost crowns formed at the inflow end of the stent in order to accommodate the exterior skirt.

Abstract: Delivery systems with telescoping capsules for delivering prosthetic heart valve devices and associated methods are disclosed herein. A delivery system configured in accordance with embodiments of the present technology can include, for example, a delivery capsule having a first housing, a second housing slidably disposed within a portion of the first housing, and a prosthetic device constrained within the first and second housings. The delivery capsule can further include first and second chamber defined in part by the first and second housings. During deployment, fluid is delivered to the first chamber to move the first housing distally over the second housing, thereby releasing a portion of the prosthetic device. Subsequently, fluid is delivered to the second chamber such that the first and second housings move together in the distal direction to release a second portion of the prosthetic device.