Abstract: A prosthetic mitral valve includes an anchor assembly, a strut frame, and a plurality of replacement leaflets secured to the annular strut frame. The anchor assembly includes a ventricular anchor, an atrial anchor, and a central portion therebetween. The ventricular anchor and the atrial anchor are configured to flare radially outwards relative to the central portion. The annular strut frame is disposed radially within the anchor assembly and is attached to the anchor assembly. The central portion is configured to align with a native valve orifice and the ventricular anchor and the atrial anchor are configured to compress native cardiac tissue therebetween.

Abstract: Systems and methods for preparing and loading a collapsible cardiac implant into a delivery system is provided, and includes a stent crimper with an alignment mechanism and a transfer tube to reduce the risk of damage to the delivery system during loading.

Abstract: A replacement heart valve comprises one or more stent frame features, including inset barbs, ring attachment structures or attachment tabs.

Abstract: Prosthetic mitral valves and their methods of manufacture and use.

Abstract: An intravascular device delivery system has an elongated member, a guidewire receiving member, and a distal cap longitudinally fixed to a guidewire receiving member. The distal cap includes an insert having an elongate member, a rim member radially separated from the elongate member, and a wall member supporting the rim member, the wall member being disposed between the rim member and the elongate member.

Abstract: A prosthetic mitral valve includes an anchor assembly, a strut frame, and a plurality of replacement leaflets secured to the annular strut frame. The anchor assembly includes a ventricular anchor, an atrial anchor, and a central portion therebetween. The ventricular anchor and the atrial anchor are configured to flare radially outwards relative to the central portion. The annular strut frame is disposed radially within the anchor assembly and is attached to the anchor assembly. The central portion is configured to align with a native valve orifice and the ventricular anchor and the atrial anchor are configured to compress native cardiac tissue therebetween.

Abstract: A method of delivering a prosthetic mitral valve includes delivering a distal anchor from a delivery sheath such that the distal anchor self-expands inside a first heart chamber on a first side of the mitral valve annulus, pulling proximally on the distal anchor such that the distal anchor self-aligns within the mitral valve annulus and the distal anchor rests against tissue of the ventricular heart chamber, and delivering a proximal anchor from the delivery sheath to a second heart chamber on a second side of the mitral valve annulus such that the proximal anchor self-expands and moves towards the distal anchor to rest against tissue of the second heart chamber. The self-expansion of the proximal anchor captures tissue of the mitral valve annulus therebetween.

Abstract: A delivery device includes a handle, a central elongate member extending from the handle, a sheath configured to slide over and relative to the central elongate member, a distal tether retainer at a distal end of the central elongate member, a proximal tether restraining mechanism positioned along the central elongate member distal of the handle and proximal of the distal tether retainer, and a plurality of tethers. The tethers are configured to extend from the proximal tether restraining mechanism to the distal tether retainer.

Abstract: A method of delivering a prosthetic mitral valve includes delivering a distal anchor from a delivery sheath such that the distal anchor self-expands inside a first heart chamber on a first side of the mitral valve annulus, pulling proximally on the distal anchor such that the distal anchor self-aligns within the mitral valve annulus and the distal anchor rests against tissue of the ventricular heart chamber, and delivering a proximal anchor from the delivery sheath to a second heart chamber on a second side of the mitral valve annulus such that the proximal anchor self-expands and moves towards the distal anchor to rest against tissue of the second heart chamber. The self-expansion of the proximal anchor captures tissue of the mitral valve annulus therebetween.

Abstract: A delivery device includes a handle, a central elongate member extending from the handle, a sheath configured to slide over and relative to the central elongate member, a distal tether retainer at a distal end of the central elongate member, a proximal tether restraining mechanism positioned along the central elongate member distal of the handle and proximal of the distal tether retainer, and a plurality of tethers. The tethers are configured to extend from the proximal tether restraining mechanism to the distal tether retainer.

Abstract: A prosthetic valve delivery device includes a handle and a delivery catheter. The delivery catheter includes a central elongate member extending from the handle and a proximal sheath configured to slide over and relative to the central elongate member. The proximal sheath is connected to a hollow helical strand, and the hollow helical strand is configured to rotate to retract the proximal sheath and expose at least a portion of the prosthetic valve.

Abstract: A delivery device includes a central elongate structure including an annular member at the distal end, a sheath, a plurality of tethers extending through the central elongate structure, a handle, and a control on the handle. The handle is connected to the elongate structure, the sheath, and the plurality of tethers. The control is configured to move the sheath proximally and distally over the central elongate structure. The annular member includes a plurality of pockets extending radially therearound. Each tether includes a feature on a distal end thereof configured to fit within a pocket of the plurality of pockets to hold the tethers in place.

Abstract: Systems and methods for delivery a medical device to a heart valve annulus are disclosed. A method of delivering a medical device to a heart valve annulus includes: (1) aligning a first imaging sensor such that a view of the first imaging sensor is along a primary plane of the heart valve annulus; (2) aligning a second imaging sensor such that a view of the second imaging sensor is along a longitudinal axis of the heart valve annulus; (3) attaching a delivery system holding the medical device to a delivery arm; (4) adjusting the delivery arm to set an angle of the delivery system perpendicular to the primary plane using images from the first imaging sensor; (5) adjusting the delivery arm to center the delivery device in the heart valve annulus using images from the second imaging sensor; and (6) deploying the medical device into the heart valve annulus.

Abstract: A prosthetic mitral valve includes an anchor assembly, a strut frame, and a plurality of replacement leaflets secured to the annular strut frame. The anchor assembly includes a ventricular anchor, an atrial anchor, and a central portion therebetween. The ventricular anchor and the atrial anchor are configured to flare radially outwards relative to the central portion. The annular strut frame is disposed radially within the anchor assembly and is attached to the anchor assembly. The central portion is configured to align with a native valve orifice and the ventricular anchor and the atrial anchor are configured to compress native cardiac tissue therebetween.

Abstract: A prosthetic mitral valve includes an anchor assembly, an annular strut frame, and a plurality of replacement leaflets secured to the annular strut frame. The anchor assembly includes a ventricular anchor, an atrial anchor, and a central portion therebetween. The annular strut frame is disposed radially within the anchor assembly. An atrial end of the annular strut frame is attached to the anchor assembly such that a ventricular end of the annular strut frame is spaced away from the anchor assembly.

Abstract: A method of delivering a prosthetic mitral valve includes delivering a distal anchor from a delivery sheath such that the distal anchor self-expands inside a first heart chamber on a first side of the mitral valve annulus, pulling proximally on the distal anchor such that the distal anchor self-aligns within the mitral valve annulus and the distal anchor rests against tissue of the ventricular heart chamber, and delivering a proximal anchor from the delivery sheath to a second heart chamber on a second side of the mitral valve annulus such that the proximal anchor self-expands and moves towards the distal anchor to rest against tissue of the second heart chamber. The self-expansion of the proximal anchor captures tissue of the mitral valve annulus therebetween.

Abstract: A method of delivering a prosthetic mitral valve includes delivering a distal anchor from a delivery sheath such that the distal anchor self-expands inside a first heart chamber on a first side of the mitral valve annulus, pulling proximally on the distal anchor such that the distal anchor self-aligns within the mitral valve annulus and the distal anchor rests against tissue of the ventricular heart chamber, and delivering a proximal anchor from the delivery sheath to a second heart chamber on a second side of the mitral valve annulus such that the proximal anchor self-expands and moves towards the distal anchor to rest against tissue of the second heart chamber. The self-expansion of the proximal anchor captures tissue of the mitral valve annulus therebetween.

Abstract: A delivery device includes a central elongate structure, a sheath, a plurality of tethers extending through the central elongate structure configured to hold a cardiac valve, a cutting mechanism, a handle, and a control. The sheath is configured to slide over the central elongate structure. The cutting mechanism is configured to cut the tethers upon activation to release the cardiac valve. The handle is connected to the central elongate structure. The control on the handle is configured to activate the cutting mechanism.

Abstract: A delivery device includes a handle, a central elongate member extending from the handle, a sheath configured to slide over and relative to the central elongate member, a distal tether retainer at a distal end of the central elongate member, a proximal tether restraining mechanism positioned along the central elongate member distal of the handle and proximal of the distal tether retainer, and a plurality of tethers. The tethers are configured to extend from the proximal tether restraining mechanism to the distal tether retainer.

Abstract: Prosthetic mitral valves and their methods of manufacture and use.