Systems for delivering a device for regulating blood pressure across a patients atrial septum are provided. The delivery apparatus may include a first catheter, a hub having one or more engagers disposed thereon, the one or more engagers configured to releasably engage with a first expandable end of the shunt in a contracted delivery state within a lumen of a sheath, and an second catheter extending through a center lumen of the first catheter and the hub, wherein the first catheter, the hub, and the second catheter are independently moveable relative to the sheath. The inventive devices may reduce left atrial pressure and left ventricular end diastolic pressure, increase cardiac output, increase ejection fraction, relieve pulmonary congestion, and lower pulmonary artery pressure, among other benefits. The inventive devices also may be used to treat subjects having heart failure, pulmonary congestion, or myocardial infarction, among other pathologies.

A device and method for predictably and controlling the collapsing of a collapsible and expandable stent for subsequent translation through a delivery sheath lumen to an anatomical target such as a heart valve or intravascular location for expansion and implantation. The loading device defines in inner lumen comprising a successively decreasing, from the proximal to the distal direction, inner diameter alternating between two sections of decreasing diameter and two sections of constant diameter until reaching the inner diameter of the delivery sheath. A fluid-filled reservoir is provided at the proximal end of the loading device that is configured to provide moisture or wetting for materials associated with or attached to the stent that require moisture retention. Thus, as the stent is being collapsed with the loading device, at least a portion of the stent may be immersed in the fluid reservoir to preserve the subject material.

Embodiments of a crimping device for crimping a radially expandable and compressible prosthetic valve are disclosed. A crimping device can comprise a housing configured to receive a prosthetic valve in a radially expanded state. The housing member can include a funnel segment and an outlet in communication with the funnel segment. The crimping device can further comprise an actuator rotatably coupled to the housing, wherein rotation of the actuator relative to the housing causes the prosthetic valve to move axially through the funnel segment such that at least a portion of the prosthetic valve compresses radially by engagement with the funnel segment and exits the crimping device via the outlet.

A delivery system for side-delivery of a prosthetic valve includes a compression device defining a lumen having a first perimeter at a proximal end that is larger than a second perimeter of the lumen at a distal end. A loading device is coupleable to the compression device and defines a lumen having substantially the second perimeter. A distal end of the loading device includes a first gate that is movable between an open state and a closed state to at least partially occlude the lumen of the loading device. A delivery device defines a lumen having substantially the second perimeter. A proximal end of the delivery device is coupleable to the distal end of the loading device and includes a second gate movable between an open state and a closed state to at least partially occlude the lumen of the delivery device.

A prosthetic heart valve includes a support frame and a plurality of leaflets disposed inside the support frame. The support frame extends between an inflow end and an outflow end and includes a leaflet frame and a plurality of positioning members coupled to the leaflet frame. The leaflet frame has an undulating shape at the outflow end of the support frame and includes a plurality of commissure regions spaced apart from each other. The positioning members are disposed between the commissure regions of the leaflet frame and extend radially outwardly relative to the leaflet frame. The positioning members are configured to contact native tissue and anchor the support frame relative to the native tissue. The leaflets are coupled to the commissure regions of the leaflet frame. The leaflets are configured to allow flow in a first direction and to substantially block flow in an opposite direction.

Methods of implanting a hybrid prosthetic aortic heart valve having a valve member and a generally tubular plastically-expandable anchoring skirt attached to and projecting in an inflow direction therefrom. The anchoring skirt has an inflow end with an initial tapered shape with a lower (inflow/leading) end defining a smaller orifice. For implant, the heart valve is advanced with the anchoring skirt at the leading end, and ultimately a balloon catheter expands within the anchoring skirt to force it into contact with a subvalvular aspect of the aortic valve annulus. To facilitate advancement of the heart valve, the anchoring skirt is further crimped after removal from a storage container such as a jar. The crimping is done after removal from the storage container to preserve an initial manufactured orifice diameter at inflow/leading end of the anchoring skirt for passage of a delivery adapter used in the delivery process.

A crimping device for a prosthetic heart valve can comprise an annular outer frame and an inner frame extending through the outer frame, the inner frame comprising first and second axial end portions and a plurality of jaw guides extending therebetween, where the inner frame defines a central opening extending therethrough. The crimping device can comprise a plurality of jaws operatively coupled to the inner and outer frames, each jaw having an inner portion positioned within the central opening of the inner frame and an engagement portion configured to slide along a respective jaw guide, each jaw guide comprising an inclined guiderail extending between the first and second axial end portions. Relative axial motion between the outer and inner frames causes radial motion of the jaws for crimping a prosthetic device positioned within the central opening.

The present disclosure describes devices, systems, and methods for loading, delivering, positioning, and deploying an artificial heart valve device at the mitral annulus. A delivery system includes a delivery member coupled to a handle assembly and extending distally from the handle assembly. The valve device is attached at the distal end of the delivery member, and is constrained within a valve cover of an outer sheath. A delivery catheter is configured to advance the valve relative to the outer sheath, and a suture catheter includes sutures/tethers which maintain proximal tension on the valve prior to deployment.

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.

A system for heart valve repair includes a packaging assembly for storing the replacement heart valve. The packaging assembly includes a valve support having a base for holding the replacement heart valve, a ring positioned within the valve support and configured to fit around a circumference of the replacement heart valve, and a retention mechanism. The retention mechanism includes a cap and plurality of sutures configured to be attached to the cap and to the replacement heart. The packaging assembly having a locked configuration in which the ring and the valve support are locked together and the sutures tension the replacement heart valve. The packaging assembly is designed to hold and transport a replacement heart valve and fits within a shipment jar.