Abstract: A delivery system includes an elongated shaft component, a self-expanding valve prosthesis, at least one cinching suture, and a radially-expandable sleeve. The valve prosthesis is disposed over a distal portion of the elongated shaft component and includes a compressed configuration for delivery and an expanded configuration for deployment. The at least one cinching suture removably couples the valve prosthesis to the elongated shaft component and radially compresses the valve prosthesis into the compressed configuration for delivery. The sleeve is secured to and encircles an outer surface of the valve prosthesis. The sleeve has a delivery state with a first diameter extending over a full length of the valve prosthesis in the compressed configuration and a deployed state with a greater second diameter extending over the full length of the valve prosthesis in the expanded configuration. The sleeve is configured to prevent paravalvular leakage in situ in the deployed state.

Abstract: A delivery system includes an elongated shaft component, a self-expanding valve prosthesis, at least one cinching suture, and a radially-expandable sleeve. The valve prosthesis is disposed over a distal portion of the elongated shaft component and includes a compressed configuration for delivery and an expanded configuration for deployment. The at least one cinching suture removably couples the valve prosthesis to the elongated shaft component and radially compresses the valve prosthesis into the compressed configuration for delivery. The sleeve is secured to and encircles an outer surface of the valve prosthesis. The sleeve has a delivery state with a first diameter extending over a full length of the valve prosthesis in the compressed configuration and a deployed state with a greater second diameter extending over the full length of the valve prosthesis in the expanded configuration. The sleeve is configured to prevent paravalvular leakage in situ in the deployed state.

Abstract: Embodiments hereof relate to methods of delivering a valve prosthesis to an annulus of a native valve of a heart, the native valve having chordae tendineae. A chordae management catheter is positioned within a ventricle of the heart, the chordae management catheter having a displacement component at a distal end thereof. The displacement component has an annular shape and defines a central lumen therethrough. The displacement component is radially expanded to push chordae tendineae within the ventricle radially outward. A valve delivery system is introduced into the ventricle of the heart via a ventricular wall of the heart. The valve delivery system has the valve prosthesis at a distal portion thereof. The valve delivery system is advanced through the central lumen of the radially expanded displacement component towards the annulus of the native valve of the heart. The valve prosthesis is deployed into apposition with the annulus of the native valve.

Abstract: A tissue-removing catheter for removing tissue in a body lumen includes an elongate body having an axis and proximal and distal end portions spaced apart from one another along the axis. A turbine is fixed to the elongate body and is disposed at an intermediate position between the proximal and distal end portions of the elongate body. A rotatable tissue-removing element is at the distal end portion of the elongate body and is operatively coupled to the turbine such that the turbine imparts rotation of the tissue-removing element. The tissue-removing element removes the tissue from the body lumen as the tissue-removing element is rotated by the turbine.

Abstract: A tissue-removing catheter for removing tissue in a body lumen includes an elongate body having an axis and proximal and distal end portions spaced apart from one another along the axis. A turbine is fixed to the elongate body and is disposed at an intermediate position between the proximal and distal end portions of the elongate body. A rotatable tissue-removing element is at the distal end portion of the elongate body and is operatively coupled to the turbine such that the turbine imparts rotation of the tissue-removing element. The tissue-removing element removes the tissue from the body lumen as the tissue-removing element is rotated by the turbine.

Abstract: Embodiments hereof relate to methods of delivering a valve prosthesis to an annulus of a native valve of a heart, the native valve having chordae tendineae. A chordae management catheter is positioned within a ventricle of the heart, the chordae management catheter having a displacement component at a distal end thereof. The displacement component has an annular shape and defines a central lumen therethrough. The displacement component is radially expanded to push chordae tendineae within the ventricle radially outward. A valve delivery system is introduced into the ventricle of the heart via a ventricular wall of the heart. The valve delivery system has the valve prosthesis at a distal portion thereof. The valve delivery system is advanced through the central lumen of the radially expanded displacement component towards the annulus of the native valve of the heart. The valve prosthesis is deployed into apposition with the annulus of the native valve.

Abstract: A delivery system includes an elongated shaft component, a self-expanding valve prosthesis, at least one cinching suture, and a radially-expandable sleeve. The valve prosthesis is disposed over a distal portion of the elongated shaft component and includes a compressed configuration for delivery and an expanded configuration for deployment. The at least one cinching suture removably couples the valve prosthesis to the elongated shaft component and radially compresses the valve prosthesis into the compressed configuration for delivery. The sleeve is secured to and encircles an outer surface of the valve prosthesis. The sleeve has a delivery state with a first diameter extending over a full length of the valve prosthesis in the compressed configuration and a deployed state with a greater second diameter extending over the full length of the valve prosthesis in the expanded configuration. The sleeve is configured to prevent paravalvular leakage in situ in the deployed state.

Abstract: A tissue-removing catheter includes an elongate body having proximal and distal end portions and a motor fixed to the distal end portion of the elongate body. A tissue-removing element is mounted on the motor to be driven in rotation by the motor about a drive axis. In some embodiments, the tissue-removing element includes a receptacle that receives the motor therein. The tissue-removing element can include a distal tip that extends distally beyond the motor to define the distal end of the catheter. The motor can be controlled using an actuator located outside the body. And in some embodiments, use of the catheter involves adjusting the rotational speed of the tissue-removing element using the actuator.

Abstract: Embodiments hereof relate to methods of delivering a valve prosthesis to an annulus of a native valve of a heart, the native valve having chordae tendineae. A chordae management catheter is positioned within a ventricle of the heart, the chordae management catheter having a displacement component at a distal end thereof. The displacement component has an annular shape and defines a central lumen therethrough. The displacement component is radially expanded to push chordae tendineae within the ventricle radially outward. A valve delivery system is introduced into the ventricle of the heart via a ventricular wall of the heart. The valve delivery system has the valve prosthesis at a distal portion thereof. The valve delivery system is advanced through the central lumen of the radially expanded displacement component towards the annulus of the native valve of the heart. The valve prosthesis is deployed into apposition with the annulus of the native valve.

Abstract: A tissue-removing catheter includes an elongate body having proximal and distal end portions and a motor fixed to the distal end portion of the elongate body. A tissue-removing element is mounted on the motor to be driven in rotation by the motor about a drive axis. In some embodiments, the tissue-removing element includes a receptacle that receives the motor therein. The tissue-removing element can include a distal tip that extends distally beyond the motor to define the distal end of the catheter. The motor can be controlled using an actuator located outside the body. And in some embodiments, use of the catheter involves adjusting the rotational speed of the tissue-removing element using the actuator.

Abstract: A delivery system includes an elongated shaft component, a self-expanding valve prosthesis, at least one cinching suture, and a radially-expandable sleeve. The valve prosthesis is disposed over a distal portion of the elongated shaft component and includes a compressed configuration for delivery and an expanded configuration for deployment. The at least one cinching suture removably couples the valve prosthesis to the elongated shaft component and radially compresses the valve prosthesis into the compressed configuration for delivery. The sleeve is secured to and encircles an outer surface of the valve prosthesis. The sleeve has a delivery state with a first diameter extending over a full length of the valve prosthesis in the compressed configuration and a deployed state with a greater second diameter extending over the full length of the valve prosthesis in the expanded configuration. The sleeve is configured to prevent paravalvular leakage in situ in the deployed state.

Abstract: Embodiments hereof relate to methods of delivering a valve prosthesis to an annulus of a native valve of a heart, the native valve having chordae tendineae. A chordae management catheter is positioned within a ventricle of the heart, the chordae management catheter having a displacement component at a distal end thereof. The displacement component has an annular shape and defines a central lumen therethrough. The displacement component is radially expanded to push chordae tendineae within the ventricle radially outward. A valve delivery system is introduced into the ventricle of the heart via a ventricular wall of the heart. The valve delivery system has the valve prosthesis at a distal portion thereof. The valve delivery system is advanced through the central lumen of the radially expanded displacement component towards the annulus of the native valve of the heart. The valve prosthesis is deployed into apposition with the annulus of the native valve.