Apparatus and methods are described herein for use in the delivery and deployment of a prosthetic mitral valve into a heart. In some embodiments, an apparatus includes a catheter assembly, a valve holding tube and a handle assembly. The valve holding tube is releasably couplable to a proximal end portion of the catheter assembly and to a distal end portion of the handle assembly. The handle assembly includes a housing and a delivery rod. The delivery rod is configured to be actuated to move distally relative to the housing to move a prosthetic heart valve disposed within the valve holding tube out of the valve holding tube and distally within a lumen of the elongate sheath of the catheter assembly. The catheter assembly is configured to be actuated to move proximally relative to the housing such that the prosthetic valve is disposed outside of the lumen of the elongate sheath.

A tool for use in loading a transcatheter valve prosthesis within a delivery catheter includes a body portion, a pivotable element and a biasing element. The body portion includes a central passageway extending form a proximal end to a distal end of the body portion. The central passageway is configured to receive a distal portion of a delivery catheter therethrough. The pivotable element is attached to the body portion and is configured to secure a tether during loading of a transcatheter valve prosthesis within the delivery catheter. The biasing element compresses the pivotable element against the body portion such that the pivotable element holds a second end against the delivery catheter and secures the tether thereto. The pivotable element may be two or more pivotable elements.

Features for a restraint, such as a cap, are described. The restraint secures a cardiac device in a collapsed, delivery configuration for transcatheter delivery to a heart. The restraint may have a tubular sidewall extending from a proximal end to a distal end, a proximal opening defined by the sidewall at the proximal end and a channel defined by the sidewall and extending distally from the proximal opening. The restraint is configured to receive the implant in the collapsed configuration through the proximal opening to radially restrain the implant within the channel. The restraint eliminates the need for a surrounding sheath, reducing the delivery profile and size of the overall delivery system, among other advantages. The restraint may have an atraumatic leading edge to reduce the risk of injury to the patient.

A prosthetic heart valve comprises an annular frame that is radially compressible and expandable between a radially compressed state and a radially expanded state, wherein the frame elongates in an axial direction when radially compressed from the radially expanded state to the radially compressed state. Leaflets are coupled to the frame such that when the frame is in the radially expanded state, the leaflets have slack in an axial direction, wherein when the frame is radially compressed to a partially radially compressed state between the radially expanded state and the radially compressed state, the leaflets are in a relaxed state, and wherein when the frame is in the radially compressed state, the leaflets are stretched in the axial direction.

Embodiments of a prosthetic valve delivery apparatus are disclosed. The delivery apparatus can include an indicator arm changeable between a first configuration and a second configuration. The second configuration is different from the first configuration in location or shape of the indicator arm. The indicator arm can be configured to remain in the first configuration when a diameter of the prosthetic valve is smaller than a first predetermined size, and change to the second configuration when the diameter of the prosthetic valve is expanded to the first predetermined size.

A transluminal sheath is advanced transseptally into a left atrium of the subject. A distal end of a surrounding-sheath, having an anchor disposed therein, is advanced via a distal end of the transluminal sheath, into a left ventricle of the subject via a commissure of the mitral valve. While the distal end of the surrounding-sheath is in the left ventricle, the surrounding-sheath is pulled proximally with respect to the anchor to expose the anchor. While the distal end of the surrounding-sheath is in the left ventricle, mitral valve tissue that is within the left ventricle is encircled by helically wrapping the anchor around the mitral valve tissue. Subsequently, the surrounding-sheath is extracted from the heart. Other embodiments are also described.

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.

Methods are described herein for delivering a replacement valve to a native valve location. In one method, ventricular anchors of the replacement valve are released and allowed to reverse orientation while positioned in the atrium of a human heart. After reversing orientation, the ventricular anchors extend in a generally proximal direction. The ventricular anchors can then be advanced through the annulus into the ventricle and then moved back toward the atrium to capture native valve leaflets between the main body and the ventricular anchors of the replacement valve. In one modification, the ventricular anchors are allowed to reverse orientation at a level adjacent the annulus. The implantation methods described herein are preferably performed via a transseptal delivery approach or a transapical delivery approach.

Embodiments of the present disclosure are directed to stents, valved-stents, and associated methods and systems for their delivery via minimally-invasive surgery.

A heart valve repair system includes a delivery sheath and an implant that includes a frame having a surface configured to contact an upstream surface of a native heart valve. First and second gripping members are coupled to the frame and each (1) includes first and second arms and (2) is configured to clamp a respective native leaflet. The implant is disposed in the sheath in a delivery state in which the frame defines a wall fully surrounding a central longitudinal axis of the implant. The distal end of the wall defines a distal opening of the frame. The distal end of the wall is disposed proximally to the entire first tissue-engaging surface of each of the gripping members and proximally to the entire second tissue-engaging surface of each of the gripping members. Other embodiments are also described.