Abstract: Apparatus and methods are provided, including a plurality of anchoring elements, each of the anchoring elements being an elongate element that is curved to define an opening. A housing holds each of the anchoring elements. A mandrel is reversibly disposable through the openings defined by the anchoring elements. The anchoring elements are configured such that, in response to removal of the mandrel from the openings, ends of the anchoring elements automatically move outwardly, and diameters of the openings decrease, due to elastic loading of the anchoring elements. Other embodiments are also described.

Abstract: A prosthesis for implantation at a native semilunar valve includes a prosthetic distal valve, which includes a pliant material configured to collapse inwardly towards a longitudinal axis of the prosthesis during diastole, and to open outwardly during systole, and a distal fixation member configured to be positioned in a downstream artery of the subject. The apparatus also includes a proximal fixation member coupled to the distal fixation member, and configured to be positioned at least partially on a ventricular side of the native semilunar valve. The proximal fixation member is shaped so as to define a lattice that is shaped so as to define an intermediary portion that is coupled to the pliant material of the valve and diverges outwardly from the longitudinal axis, and a distal portion that is distal to the intermediary portion and diverges outwardly from the intermediary portion of the lattice. Other embodiments are also described.

Abstract: A prosthesis for implantation at a native semilunar valve includes a prosthetic distal valve, which includes a pliant material configured to collapse inwardly towards a longitudinal axis of the prosthesis during diastole, and to open outwardly during systole, and a distal fixation member configured to be positioned in a downstream artery of the subject. The apparatus also includes a proximal fixation member coupled to the distal fixation member, and configured to be positioned at least partially on a ventricular side of the native semilunar valve. The proximal fixation member is shaped so as to define a lattice that is shaped so as to define an intermediary portion that is coupled to the pliant material of the valve and diverges outwardly from the longitudinal axis, and a distal portion that is distal to the intermediary portion and diverges outwardly from the intermediary portion of the lattice. Other embodiments are also described.

Abstract: A prosthesis is provided for implantation at a native semilunar valve of a native valve complex, the native valve complex having three semilunar sinuses and three native commissures. The prosthesis includes a valve prosthesis support, which comprises a support structure comprising exactly three engagement arms that meet one another at three respective junctures. The engagement arms are shaped so as define three peak complexes at the three respective junctures, and three trough complexes, each of which is between two of the peak complexes. Upon implantation of the prosthesis, each of the engagement arms is at least partially disposed within a respective one of the semilunar sinuses, such that each of the peak complexes is disposed distal to and in rotational alignment with a respective one of the native commissures, and each of the trough complexes is disposed at least partially within the respective one of the semilunar sinuses.

Abstract: A prosthesis is provided for implantation at a native semilunar valve of a native valve complex, the native valve complex having three semilunar sinuses and three native commissures. The prosthesis includes a valve prosthesis support, which comprises a support structure comprising exactly three engagement arms that meet one another at three respective junctures. The engagement arms are shaped so as define three peak complexes at the three respective junctures, and three trough complexes, each of which is between two of the peak complexes. Upon implantation of the prosthesis, each of the engagement arms is at least partially disposed within a respective one of the semilunar sinuses, such that each of the peak complexes is disposed distal to and in rotational alignment with a respective one of the native commissures, and each of the trough complexes is disposed at least partially within the respective one of the semilunar sinuses.

Abstract: A prosthesis is provided for implantation at a native semilunar valve of a native valve complex, the native valve complex having three semilunar sinuses and three native commissures. The prosthesis includes a valve prosthesis support, which comprises a support structure comprising exactly three engagement arms that meet one another at three respective junctures. The engagement arms are shaped so as define three peak complexes at the three respective junctures, and three trough complexes, each of which is between two of the peak complexes. Upon implantation of the prosthesis, each of the engagement arms is at least partially disposed within a respective one of the semilunar sinuses, such that each of the peak complexes is disposed distal to and in rotational alignment with a respective one of the native commissures, and each of the trough complexes is disposed at least partially within the respective one of the semilunar sinuses.

Abstract: A prosthesis for implantation at a native semilunar valve includes a prosthetic distal valve, which includes a pliant material configured to collapse inwardly towards a longitudinal axis of the prosthesis during diastole, and to open outwardly during systole, and a distal fixation member configured to be positioned in a downstream artery of the subject. The apparatus also includes a proximal fixation member coupled to the distal fixation member, and configured to be positioned at least partially on a ventricular side of the native semilunar valve. The proximal fixation member is shaped so as to define a lattice that is shaped so as to define an intermediary portion that is coupled to the pliant material of the valve and diverges outwardly from the longitudinal axis, and a distal portion that is distal to the intermediary portion and diverges outwardly from the intermediary portion of the lattice. Other embodiments are also described.

Abstract: A prosthetic heart valve capable of being delivered via a transfemoral route as described.

Abstract: Apparatus and methods are provided including a mitral valve prosthesis. The prosthesis includes an inner support structure having downstream and upstream sections, the upstream section having a cross-sectional area greater than the downstream section. The inner support structure is configured to be positioned on an atrial side of the native valve complex, and to prevent the prosthesis from being dislodged into the left ventricle. A prosthetic valve having prosthetic valve leaflets is coupled to the inner support structure. An outer support structure has engagement arms, downstream ends of the engagement arms being coupled to the inner support structure. The prosthesis is configured such that, upon implantation thereof: downstream ends of the native valve leaflets, downstream ends of the engagement arms, and downstream ends of the prosthetic leaflets, are disposed at a longitudinal distance from one another of less than 3 mm. Other embodiments are also described.

Abstract: A mitral valve prosthesis and methods for implanting the prosthesis transapically (i.e., through the apex of the heart), transatrially (i.e., through the left atrium of the heart), and transseptally (i.e., through the septum of the heart). The prosthesis generally includes a self-expanding frame and two or more support arms. A valve prosthesis is sutured to the self-expanding frame. Each support arm corresponds to a native mitral valve leaflet. At least one support arm immobilizes the native leaflets, and holds the native leaflets close to the main frame.

Abstract: A prosthetic apparatus for implantation at a native valve complex includes a main body configured for placement within the native valve, at least one downstream arm and at least one upstream arm, each coupled to and disposed outside of the main body. The main body includes a compressed state for delivery and an expanded state. In the expanded state, a space exists between the downstream arm and an outer surface of the main body to receive an edge of a native valve leaflet. A portion of the downstream arm is configured to extend behind the received native leaflet and engage a downstream surface of the native valve complex while the edge of the received native leaflet is not engaged by the downstream arm. The upstream arm is configured to engage an upstream surface of the native valve complex at a location opposite the portion of the downstream arm.

Abstract: A loading tool for withdrawing, crimping, and loading a stent-mounted valve into a delivery catheter, and for pushing the stent-mounted valve from the delivery catheter into a native heart valve orifice. The loading tool comprises at least one connector adapted for being removably connected to the stent of the stent-mounted valve. A crimping tool having a generally converging shape is adapted for use with the loading tool. Following connection of the loading tool to the stent-mounted valve, the loading tool operates to allow the stent-mounted valve to be drawn through the crimping tool, and loaded, in, a crimped state, into a delivery catheter. Also disclosed is a kit of the of the various components for effecting the delivery of the stent-mounted valve and a method for withdrawing, crimping, and loading a stent-mounted valve from a storage container into a delivery catheter for the performance of a transcatheter valve implantation procedure.

Abstract: Apparatus and methods are provided for use with a mitral valve of a heart of a subject. The apparatus includes a P1-anchor, a P2-anchor, and a P3-anchor, that are anchored to tissue in a vicinity of, respectively, P1, P2 and P3 segments of a posterior leaflet of the mitral valve, a tether being fixedly coupled to the P2-anchor, and slidably coupled to the P1 and P3 anchors. A cardiac-site anchor anchors the tether to an anchoring location that is at a cardiac site that is anterior and inferior to the posterior leaflet. Other embodiments are also described.

Abstract: A prosthetic apparatus includes a main body having a lumen and configured for placement within a native annulus of a native valve complex. The main body is radially compressible to a radially compressed state for delivery into the heart and self-expandable from the compressed state to a radially expanded state. The apparatus also includes at least one arm coupled to and disposed outside of the main body. The arm being coupled to the main body such that when the main body is compressed to the compressed state, a leaflet-receiving space between the arm and an outer surface of the main body increases to receive a native valve leaflet therebetween, and when the main body expands to the expanded state in the absence of any radial inward forces on the main body or the arm, the space decreases to capture the leaflet between the outer surface of the main body and the arm.

Abstract: A prosthesis is provided for implantation at a native semilunar valve of a native valve complex, the native valve complex having three semilunar sinuses and three native commissures. The prosthesis includes a valve prosthesis support, which comprises a support structure comprising exactly three engagement arms that meet one another at three respective junctures. The engagement arms are shaped so as define three peak complexes at the three respective junctures, and three trough complexes, each of which is between two of the peak complexes. Upon implantation of the prosthesis, each of the engagement arms is at least partially disposed within a respective one of the semilunar sinuses, such that each of the peak complexes is disposed distal to and in rotational alignment with a respective one of the native commissures, and each of the trough complexes is disposed at least partially within the respective one of the semilunar sinuses.

Abstract: Apparatus and methods are provided for use with a mitral valve of a heart of a subject. The apparatus includes a P1-anchor, a P2-anchor, and a P3-anchor, that are anchored to tissue in a vicinity of, respectively, P1, P2 and P3 segments of a posterior leaflet of the mitral valve, a tether being fixedly coupled to the P2-anchor, and slidably coupled to the P1 and P3 anchors. A cardiac-site anchor anchors the tether to an anchoring location that is at a cardiac site that is anterior and inferior to the posterior leaflet. Other embodiments are also described.

Abstract: A catheter system configured to deploy a valve prosthesis can include a catheter tip at a distal end of the catheter system. The catheter tip can include a device holder releasably connected to and retaining the prosthesis. The catheter tip can also include a first housing portion that accommodates the first portion of the prosthesis, and a second housing portion that accommodates the second portion of the prosthesis. The first housing portion and the second housing portion are configured to move relative to one another such that the catheter system sequentially releases the prosthesis to an expanded state by uncovering the second portion of the prosthesis allowing the second portion of the prosthesis to expand.

Abstract: A prosthesis for implantation at a native semilunar valve includes a prosthetic distal valve, which includes a pliant material configured to collapse inwardly towards a longitudinal axis of the prosthesis during diastole, and to open outwardly during systole, and a distal fixation member configured to be positioned in a downstream artery of the subject. The apparatus also includes a proximal fixation member coupled to the distal fixation member, and configured to be positioned at least partially on a ventricular side of the native semilunar valve. The proximal fixation member is shaped so as to define a lattice that is shaped so as to define an intermediary portion that is coupled to the pliant material of the valve and diverges outwardly from the longitudinal axis, and a distal portion that is distal to the intermediary portion and diverges outwardly from the intermediary portion of the lattice. Other embodiments are also described.

Abstract: A mitral valve prosthesis and methods for implanting the prosthesis transapically (i.e., through the apex of the heart), transatrially (i.e., through the left atrium of the heart), and transseptally (i.e., through the septum of the heart). The prosthesis generally includes a self-expanding frame and two or more support arms. A valve prosthesis is sutured to the self-expanding frame. Each support arm corresponds to a native mitral valve leaflet. At least one support arm immobilizes the native leaflets, and holds the native leaflets close to the main frame.

Abstract: Apparatus and methods are provided for use with a mitral valve of a heart of a subject. The apparatus includes a P1-anchor, a P2-anchor, and a P3-anchor, that are anchored to tissue in a vicinity of, respectively, P1, P2and P3segments of a posterior leaflet of the mitral valve, a tether being fixedly coupled to the P2-anchor, and slidably coupled to the P1and P3anchors. A cardiac-site anchor anchors the tether to an anchoring location that is at a cardiac site that is anterior and inferior to the posterior leaflet. Other embodiments are also described.