Abstract: A transcatheter valve prosthesis including a tubular stent, a prosthetic valve component disposed within and secured to the stent, and a centering mechanism coupled to and encircling an outer surface of the tubular stent. The centering mechanism includes a self-expanding centering ring having an expanded diameter in the expanded configuration that is greater than an expanded diameter of the tubular stent in the expanded configuration and a plurality of self-expanding spokes radially extending between the tubular stent and the centering ring. The centering mechanism may include a base ring and/or a skirt. Alternatively, the centering mechanism includes a plurality of self-expanding loops. When each loop is in a delivery configuration the loop has a straightened profile that proximally extends from a proximal end of the tubular stent. When each loop is in an expanded configuration the loop has a U-shaped profile radially spaced apart from the tubular stent.

Abstract: A delivery device for percutaneously delivering a stented prosthetic heart valve includes a capsule assembly, a handle, and an outer stability shaft. The capsule assembly includes a capsule and a proximal shaft coupled to the capsule. The capsule includes an expanded configuration wherein the capsule has a first outer diameter, and a collapsed configuration wherein the capsule has a second outer diameter smaller than the first outer diameter. The outer stability shaft defines a lumen and is coupled to the handle and configured to receive the proximal shaft within the lumen of the outer stability shaft. The outer stability shaft has an inner diameter, wherein the first outer diameter of the capsule is greater than the inner diameter of the outer stability shaft and the second outer diameter of the capsule is smaller than the inner diameter of the outer stability shaft.

Abstract: Embodiments hereof relate to a delivery system for a transcatheter valve prosthesis, the delivery system having an integral centering mechanism to circumferentially center both the delivery system and the valve prosthesis within a vessel at the target implantation site. The centering mechanism may include expandable wings that may be selectively aligned with openings formed through a sidewall of an outer shaft of the delivery system, a coiled wing that may be selectively exposed through an opening formed through a sidewall of an outer shaft of the delivery system, a plurality of elongated filaments extending through a plurality of lumens of an outermost shaft of the delivery system that may be selectively deployed or expanded, an outer shaft that includes at least one pre-formed deflection segment formed thereon, a tool having a deployable lever arm, and/or a plurality of loops deployable via simultaneous longitudinal and rotational movement.

Abstract: The present disclosure relates to numerous devices and methods for transcatheter stented prosthetic heart valve loading and delivery. Such devices and methods reduce suture tangling and also provide the ability to adjust the stented prosthetic heart valve expansion and contraction prior to the final release of the stented prosthetic heart valve from the delivery device.

Abstract: A delivery device for percutaneously delivering a stented prosthetic heart includes a sheath, a handle, and adjustment device including a fine adjustment mechanism, and an outer stability shaft. The sheath defines a lumen and is configured to compressively constrain the stented prosthetic heart valve. The handle is coupled to the proximal portion of the sheath and includes an actuator mechanism coupled to a proximal portion of the sheath that is configured to selectively move the sheath relative to the housing to release the stented prosthetic heat valve. The adjustment device is coupled to the handle and includes an adjustment lumen through which the sheath and the handle slidably extend. The outer stability shaft is coupled to the adjustment device. The fine adjustment mechanism is configured to selectively move the handle and the sheath relative to the adjustment device and the outer stability shaft.

Abstract: A system for percutaneous delivery of a stented prosthetic heart valve. The system includes a delivery device with a self-expanding prosthetic heart valve attached thereto and a delivery sheath with an opening on a distal end thereof. The delivery sheath includes a funnel on a proximal end thereof. The delivery device is inserted into the funnel of the delivery sheath. As the delivery device is advanced into the funnel, the expanded heart valve is compressed by the shape of the funnel into a crimped arrangement. The delivery device further advances the heart valve distally within the delivery sheath past the delivery sheath opening. The delivery device is advanced relative to the delivery sheath in transitioning the heart valve from a crimped arrangement to the expanded and deployed arrangement.

Abstract: Aspects of the disclosure relate to devices and methods for preparing an existing, implanted prosthetic aortic valve for subsequent prosthetic aortic valve implantation. To prepare the existing valve, a valve preparation device is delivered to the valve and valve leaflets are severed either via mechanical cutting or electrodes so that the leaflets cannot obstruct a blood flow path once a prosthetic valve is subsequently implanted within the valve. Similarly, in alternate embodiments, devices and methods of the disclosure can be used for preparing a native aortic valve for delivery and implantation of a prosthetic valve.

Abstract: A system for treating valvular regurgitation in a heart valve includes a flexible canopy and an elongated tether including an elastic portion and an inelastic portion. When the system is in a deployed configuration, a proximal end of the flexible canopy is coupled to an annulus of the heart valve and a distal end of the elongated tether is coupled to a ventricle. The flexible canopy is configured to overlay a first native leaflet of the heart valve, and tension on the elongated tether is applied and/or adjusted to prevent the first leaflet from prolapsing, to maximize coaptation of the flexible canopy with a second native leaflet of the heart valve, and to minimize regurgitation of the heart valve.

Abstract: Disclosed embodiments and methods provide solutions for coupling and decoupling of a delivery device from a stented prosthetic heart valve with one or more release mechanisms. In situations when one or more sutures get tangled or caught upon attempted retraction of the delivery device and sutures after deployment of the stented prosthetic heart valve, a secondary release mechanism can be provided to sever the suture(s) or release the suture(s) from the delivery device. Exemplary secondary release mechanisms include high resistance inserts, cutters and balloon expandable devices. Methods of releasing the sutures from the delivery device or severing the suture(s) are also disclosed.

Abstract: The present disclosure relates to numerous devices and methods for transcatheter stented prosthetic heart valve loading and delivery. Such devices and methods reduce suture tangling and also provide the ability to adjust the stented prosthetic heart valve expansion and contraction prior to the final release of the stented prosthetic heart valve from the delivery device.

Abstract: A system for percutaneous delivery of a stented prosthetic heart valve. The system includes a delivery device with a self-expanding prosthetic heart valve attached thereto and a delivery sheath with an opening on a distal end thereof. The delivery sheath includes a funnel on a proximal end thereof. The delivery device is inserted into the funnel of the delivery sheath. As the delivery device is advanced into the funnel, the expanded heart valve is compressed by the shape of the funnel into a crimped arrangement. The delivery device further advances the heart valve distally within the delivery sheath past the delivery sheath opening. The delivery device is advanced relative to the delivery sheath in transitioning the heart valve from a crimped arrangement to the expanded and deployed arrangement.

Abstract: A transcatheter valve prosthesis including a tubular stent, a prosthetic valve component disposed within and secured to the stent, and a centering mechanism coupled to and encircling an outer surface of the tubular stent. The centering mechanism includes a self-expanding centering ring having an expanded diameter in the expanded configuration that is greater than an expanded diameter of the tubular stent in the expanded configuration and a plurality of self-expanding spokes radially extending between the tubular stent and the centering ring. The centering mechanism may include a base ring and/or a skirt. Alternatively, the centering mechanism includes a plurality of self-expanding loops. When each loop is in a delivery configuration the loop has a straightened profile that proximally extends from a proximal end of the tubular stent. When each loop is in an expanded configuration the loop has a U-shaped profile radially spaced apart from the tubular stent.

Abstract: A delivery device for percutaneously delivering a stented prosthetic heart includes a sheath, a handle, and adjustment device including a fine adjustment mechanism, and an outer stability shaft. The sheath defines a lumen and is configured to compressively constrain the stented prosthetic heart valve. The handle is coupled to the proximal portion of the sheath and includes an actuator mechanism coupled to a proximal portion of the sheath that is configured to selectively move the sheath relative to the housing to release the stented prosthetic heat valve. The adjustment device is coupled to the handle and includes an adjustment lumen through which the sheath and the handle slidably extend. The outer stability shaft is coupled to the adjustment device. The fine adjustment mechanism is configured to selectively move the handle and the sheath relative to the adjustment device and the outer stability shaft.

Abstract: A catheter-based system for percutaneously supporting and articulating a septal wall of a heart includes a catheter and a flanged device. The flanged device includes a distal anchor and a proximal anchor, and has a radially collapsed configuration and a radially expanded configuration. When the flanged device is in the radially expanded configuration and disposed through a transseptal puncture in the septal wall, the flanged device is configured to anchor to the septal wall to permit manipulation thereof whereby an angle between an axis through the transseptal puncture and an axis through a native valve is reduced. The proximal anchor and the distal anchor may each be self-expanding or balloon expandable. The flanged device may further include a flanged device shaft. The flanged device shaft may be releasably coupled to the catheter.

Abstract: Embodiments hereof relate to a transcatheter valve prosthesis including a tubular fabric body, a first or inflow tubular scaffold attached to a first end portion of the tubular fabric body, and a second or outflow tubular scaffold attached to a second end portion of the tubular fabric body. A prosthetic valve component is disposed within and secured to an intermediate portion of the tubular fabric body that longitudinally extends between the first and second end portions of the tubular fabric body. The intermediate portion is unsupported such that neither of the first and second tubular scaffolds surrounds the intermediate portion of the tubular fabric body. The intermediate portion may include one or more windows for coronary access and may include one or more commissure reinforcement members coupled thereto to provide support for the prosthetic valve component.

Abstract: A system for replacing a heart valve of a patient. The system includes a delivery device and a prosthetic heart valve. The system is configured to be transitionable between a loaded state, a partially deployed state and a deployed state. In the loaded state, the prosthetic heart valve engages a coupling structure and is compressively retained within a primary capsule, which constrains the prosthetic heart valve in a compressed arrangement. In the partially deployed state, the prosthetic heart valve engages the coupling structure and is compressively retained within a secondary capsule, which constrains the prosthetic heart valve to a partially deployed arrangement. The partially deployed arrangement is less compressed than the compressed arrangement and less expanded than a deployed arrangement. In the deployed state, the primary and secondary capsules are retracted from over the prosthetic heart valve, which expands to the deployed arrangement and is released from the coupling structure.

Abstract: Systems and methods of delivering and deploying a stented prosthetic heart valve having a wrap that is automatically deployed to prevent or mitigate paravalvular leakage. In various embodiments, during transcatheter delivery of the stented prosthetic heart valve, the wrap is extends beyond a stent frame of the stented prosthetic heart valve so that the profile of the stented prosthetic heart valve is not increased during delivery. The disclosed embodiments are arranged and configured so that upon expansion of a stent frame of the stented prosthetic heart valve, a plurality of elongated members automatically pull the wrap distally into a deployed arrangement.

Abstract: An embolic protection device includes a shaft, a first magnet fixedly coupled to a distal portion of the shaft, a second magnet slidingly coupled to the shaft proximal to the first magnet, and a filter including a distal portion coupled to the first magnet and a proximal portion coupled to the second magnet. The first and second magnets are magnetically attracted to each other such that in a radially compressed configuration of the filter, the second magnet is spaced from the first magnet a first distance, and in a radially expanded configuration of the filter, the second magnet slides towards the first magnet such that the second magnet is spaced a second distance from the first magnet, wherein the second distance is smaller than the first distance.

Abstract: A system for replacing a heart valve of a patient. The system includes a delivery device and a prosthetic heart valve. The system is configured to be transitionable between a loaded state, a partially deployed state and a deployed state. In the loaded state, the prosthetic heart valve engages a coupling structure and is compressively retained within a primary capsule, which constrains the prosthetic heart valve in a compressed arrangement. In the partially deployed state, the prosthetic heart valve engages the coupling structure and is compressively retained within a secondary capsule, which constrains the prosthetic heart valve to a partially deployed arrangement. The partially deployed arrangement is less compressed than the compressed arrangement and less expanded than a deployed arrangement. In the deployed state, the primary and secondary capsules are retracted from over the prosthetic heart valve, which expands to the deployed arrangement and is released from the coupling structure.

Abstract: The disclosure relates to transcatheter stented prosthesis delivery devices including transition elements that route, constrain, support and reduce damage to tension member wear as tension in the tension members is varied to adjust the compression of a stented prosthesis loaded onto the delivery device. Various disclosed tension elements include inserts, edge treatments and guides proximate a distal portion of the delivery device upon which the stented prosthesis is loaded. In some embodiments, the transition feature is positioned proximate a location where at least one tension member transitions from a first orientation that is not parallel to the distal portion to a second orientation that is generally parallel to the distal portion. Further embodiments disclose configurations and methods of selectively locking and unlocking a longitudinal and/or rotational position of the stent frame with respect to the distal portion of the delivery device.