Abstract: An assembly for replacement of a native aortic heart valve includes a radially collapsible prosthetic heart valve and a delivery apparatus. The prosthetic heart valve includes an annular frame with attachment posts, wherein each of the posts has an axial post portion and a transverse post portion having a greater circumferential dimension than the axial post portion. The delivery apparatus includes an inner shaft with a valve connection portion for releasably coupling to the attachment posts and an outer shaft having a sheath for maintaining the prosthetic heart valve in a radially compressed state. Rotation of a control knob on a handle causes the sheath to retract for uncovering a portion of the prosthetic heart valve. Further rotation of the control knob allows the posts to decouple from the delivery apparatus such that the prosthetic heart valve self-expands to a fully expanded state.

Abstract: A delivery assembly includes a prosthetic device, a catheter shaft, a release wire, a first line, and a second line. The prosthetic device has a first arm and a second arm. The release wire extends through the catheter shaft. The first line includes a first loop. The first line extends from the catheter shaft, through the first arm of the prosthetic device, and to the release wire, where the release wire extends through the first loop. The second line includes a second loop. The second line extends from the catheter shaft, through the second arm of the prosthetic device, and to the release wire, where the release wire extends through the second loop.

Abstract: A left atrium appendage (LAA) isolator, including: a body sized and shaped to fit an at least partially inverted LAA of a human adult, wherein a distal end of said body defines a two-state sealing adaptor interface configured in a first state to apply a radially outward force against a wall of said LAA or against a wall of said LAA opening sufficient to anchor said body to the LAA wall, and in a second state the sealing adaptor interface is configured to apply a radially inward force on a portion of the inverted LAA positioned within said body.

Abstract: An assembly for replacement of a native aortic heart valve includes a radially collapsible prosthetic heart valve and a delivery apparatus. The prosthetic heart valve includes an annular frame with attachment posts, wherein each of the posts has an axial post portion and a transverse post portion having a greater circumferential dimension than the axial post portion. The delivery apparatus includes an inner shaft with a valve connection portion for releasably coupling to the attachment posts and an outer shaft having a sheath for maintaining the prosthetic heart valve in a radially compressed state. Rotation of a control knob on a handle causes the sheath to retract for uncovering a portion of the prosthetic heart valve. Further rotation of the control knob allows the posts to decouple from the delivery apparatus such that the prosthetic heart valve self-expands to a fully expanded state.

Abstract: A device for fracturing calcifications in heart valves includes a stabilizer and an impactor movable towards each other. The impactor includes one or more impactor arms, each of which extends distally from a proximal cap. The impactor further includes one or more lever arms each of which is distally coupled to a lever cap and proximally coupled to a corresponding one of the one or more impactor arms. The lever cap slides on a shaft which extends towards the proximal cap. Proximal movement of the lever cap towards the proximal cap causes the one or more lever arms to deform and to push against the one or more impactor arms and to cause the one or more impactor arms to deform.

Abstract: A left atrium appendage (LAA) isolator, including: a body sized and shaped to fit an at least partially inverted LAA of a human adult, wherein a distal end of said body defines a two-state sealing adaptor interface configured in a first state to apply a radially outward force against a wall of said LAA or against a wall of said LAA opening sufficient to anchor said body to the LAA wall, and in a second state the sealing adaptor interface is configured to apply a radially inward force on a portion of the inverted LAA positioned within said body.

Abstract: Apparatus and methods are described including placing a valve frame within a subject's heart. The valve frame includes a valve frame body that is configured to support the prosthetic valve within the native atrio-ventricular valve, and at least one arm that is configured to extend from a ventricular portion of the valve frame. The at least one arm is deployed among chords of the native atrio-ventricular valve. Subsequently, at least a portion of the valve frame is rotated in a direction in which an interior of the arm faces, such as to modify shapes of the native valve leaflets and the ventricular structures, by recruiting and deflecting at least a portion of the chords. The frame body of the valve frame is then radially expanded, such as to hold the native valve leaflets and the ventricular structures at least partially in the modified shapes. Other applications are also described.

Abstract: Prosthetic heart valves and methods of implantation thereof are disclosed herein. In embodiments, a prosthetic heart valve includes a self-expandable frame configured to support of valve member and comprising a plurality of interconnected strut members forming a mesh structure. An inflow end and outflow end portions of the mesh structure respectively define an inflow terminal end and an outflow terminal end of the frame. A portion of the frame tapers inwardly from the inflow terminal end to form a reduced diameter section. In implementations, the frame increases in diameter from the reduced diameter section to an intermediate section. In implementations, the valve member is secured to the frame at the inflow end portion. In implementations, the frame further comprises a plurality of retaining arms that extend from the outflow terminal end and are configured to engage with a valve retaining mechanism of a delivery apparatus.

Abstract: A method for closure of the left atrial appendage (LAA), including: placing an LAA reshaper in contact with an LAA wall or near the LAA wall; invaginating at least a portion of the LAA into the left atrium (LA); reshaping by the LAA reshaper the LAA during the invagination; fastening the invaginated at least a portion of said LAA; and retracting the LAA reshaper from the LAA

Abstract: A calcification treatment device includes a catheter with proximal and distal ends. The catheter has at its distal end a non-occluding expansion element movable from a closed to an open position. In the open position, the expansion element is configured to apply force to leaflets of a valve so as to forcefully open the leaflets.

Abstract: A prosthetic heart valve includes a frame, a valvular structure coupled to the frame, and a sealing member coupled to the frame. The frame has inflow and outflow ends and a lumen extending therebetween. The frame includes struts that form cells, and the cells are arranged in three rows. The frame is radially expandable from a collapsed state to an expanded state. The valvular structure includes a plurality of leaflets configured to allow blood flow through the lumen of the frame from the inflow end to the outflow end and to block blood flow through the lumen of the frame from the outflow end to the inflow end. The sealing skirt extends from an intermediate location of the frame disposed between the inflow and outflow ends to the inflow end of the frame. The sealing skirt covers two rows of cells to block blood flow through the cells.

Abstract: Prosthetic heart valves and methods of implantation thereof are disclosed herein. In embodiments, a prosthetic heart valve includes a self-expandable frame configured to support of valve member and comprising a plurality of interconnected strut members forming a mesh structure. An inflow end and outflow end portions of the mesh structure respectively define an inflow terminal end and an outflow terminal end of the frame. A portion of the frame tapers inwardly from the inflow terminal end to form a reduced diameter section. In implementations, the frame increases in diameter from the reduced diameter section to an intermediate section. In implementations, the valve member is secured to the frame at the inflow end portion. In implementations, the frame further comprises a plurality of retaining arms that extend from the outflow terminal end and are configured to engage with a valve retaining mechanism of a delivery apparatus.

Abstract: A delivery assembly includes a prosthetic device, a catheter shaft, a release wire, a first line, and a second line. The prosthetic device has a first arm and a second arm. The release wire extends through the catheter shaft. The first line includes a first loop. The first line extends from the catheter shaft, through the first arm of the prosthetic device, and to the release wire, where the release wire extends through the first loop. The second line includes a second loop. The second line extends from the catheter shaft, through the second arm of the prosthetic device, and to the release wire, where the release wire extends through the second loop.

Abstract: A prosthetic heart valve for replacing a defective aortic valve includes a self-expandable annular frame made of shape-memory material. A one-way valve structure is disposed within an interior of the frame. The frame includes a plurality of posts projecting axially from an outflow end portion of the frame, wherein each of the posts includes an axial post portion and a terminal post portion. The terminal post portions have greater circumferential dimensions than the axial post portions. The terminal post portions are preferably formed with concave inner surfaces and convex outer surfaces for conforming to the shape of a delivery catheter. Each of the posts is shaped for placement within a corresponding recess along a distal end portion of the delivery catheter for ensuring that the prosthetic heart valve remains coupled to the delivery catheter while the prosthetic heart valve is expanded within the defective aortic valve.

Abstract: Apparatus and methods are described including a valve frame defining a frame aperture and at least one arm attached to a portion of the valve frame on a ventricular side of said frame aperture. The at least one arm is configured to extend radially from the portion of the valve frame such that a chord receiving surface of the arm is sized and shaped to deploy among a region of the chords of the native mitral valve. The arm is curved, with an interior of the arm facing a direction in which the valve frame is configured to be rotated during deployment of the prosthetic mitral valve apparatus within the native mitral valve and with the arm having a concavely rounded leading edge facing at least partially in a circumferential direction. Other applications are also described.

Abstract: A handle assembly for a transvascular prosthetic heart valve delivery apparatus including a handle housing, a main shaft extending distally from the handle housing, the main shaft configured to be coupled to a distal valve sheath that is configured to retain a prosthetic heart valve in a radially compressed state within the valve sheath, a screw shaft, a control knob that is rotatable relative to the handle housing and the screw shaft, a screw engagement latch that is adjustable between an engaged position and a disengaged position. In the engaged position, the latch can couple the control knob to the screw shaft such that rotation of the control knob relative to the handle housing causes the main shaft to move axially relative to the handle housing. In the disengaged position, the latch can decouple the control knob from the screw shaft such that the main shaft can move axially relative to the handle housing without rotation of the control knob.

Abstract: A method of delivering a prosthetic heart valve to a native aortic heart valve region of a patient can include introducing a prosthetic heart valve on a transvascular delivery apparatus into an artery of the patient, advancing the delivery apparatus through an aorta of the patient to the native aortic heart valve region, and releasing the prosthetic heart valve from the delivery apparatus. The delivery apparatus can have a shaft with a valve connection portion that is releasably coupled to posts of the prosthetic heart valve. The delivery apparatus can have a delivery sheath positioned around the prosthetic heart valve and the valve connection portion. The releasing the prosthetic valve can include moving the delivery sheath proximally relative to the shaft and the prosthetic heart valve such that the delivery sheath uncovers the prosthetic heart valve and the prosthetic heart valve can self-expand.

Abstract: An assembly for replacing a native heart valve can have a prosthetic heart valve with an annular metal frame made from shape-memory material and a valve member disposed in an interior of the metal frame. The assembly can have a delivery apparatus with a handle, a shaft with a proximal end portion and a distal end portion. The proximal end portion can be coupled to the handle and the distal end portion can be releasably coupled to the prosthetic heart valve. The delivery apparatus can also have a delivery sheath and a hydraulic power source operatively connected to the delivery sheath. The prosthetic heart valve can be positioned within the delivery sheath in a radially compressed state. The hydraulic power source can be configured to move the delivery sheath longitudinally relative to the valve to allow the valve to self-expand from the radially compressed state to a radially expanded state.

Abstract: A prosthetic heart valve includes a collapsible and expandable annular frame. The frame includes a plurality of rows of hexagonal cells. Each of the hexagonal cells is defined by six struts, including: two opposing side struts extending parallel to each other, a first pair of angled struts extending from respective first ends of the side struts and converging to intersect with each other, and a second pair of angled struts extending from respective second ends of the side struts and converging to intersect with each other. The prosthetic heart valve can also include a valvular structure with a plurality of leaflets. The prosthetic heart valve can further include a sealing member.

Abstract: Prosthetic valve systems for treating a native valve exhibiting regurgitation can include a support structure in which a separate prosthetic heart valve can be placed. A method for implant a prosthetic valve system can include advancing a first catheter delivery sheath through an introducer sheath and into a left ventricle of a patient's heart, deploying at least a portion of a support structure from the first catheter delivery sheath and positioning the support structure around native leaflets of the patient's native mitral valve, positioning a prosthetic heart valve in a radially collapsed configuration within the patient's native mitral valve, and expanding the prosthetic heart valve from the radially collapsed configuration to a radially expanded configuration, wherein the prosthetic heart valve contacts the native leaflets from within the patient's native mitral valve and is separated from the support structure by the native leaflets.