During a medical procedure, a transseptal fenestration is made at a septum of the heart and a shunt is implanted into the transseptal fenestration. During the same medical procedure, a transapical puncture is made into a left ventricle of the heart. A prosthetic valve is delivered via the transapical puncture and implanted at a mitral valve of the heart. Subsequently to delivering the prosthetic valve and making the transseptal fenestration, the transapical puncture is closed. Other embodiments are also described.

Disclosed herein are delivery systems and delivery assemblies comprising a co-extruded elongated polymeric sleeve comprising an inner polymer layer and an outer polymer layer, which form two lumens having a different diameter, wherein the inner polymer layer comprises a fluoropolymer; and wherein the outer polymer layer comprises a polyamide, or a polyether block amide, or a combination thereof. Also disclosed are methods of making and using the same.

A method for providing blood flow across a surface of a mitral stent-valve frame. A portion of the stent-valve frame is placed into the left atrium and into the left ventricle with a securement band located intermediate that is attached to either the annulus or to a second support frame that is placed initially and above the mitral annulus without affecting native leaflet function. Portions of the frame above the securement band allow blood flow radially inwards to reduce stagnation regions in the atrium or outwards below the securement band to help cleanse native leaflets.

Systems, devices and methods related to various heart valve implants and for delivery of those heart valve implants are described. The implants may be used to re-size a native valve annulus or to replace a native heart valve. The implants include a re-sizable frame having angled struts. Anchors secure the implant to tissue and collars are used to decrease the angle between the struts and contract the frame. The implant thus expands from a first size inside of a delivery catheter, to a second and larger deployed size inside the heart to engage and anchor with the tissue, and then to a third and contracted size to re-size the annulus and/or provide a secure fit for a replacement heart valve. Various delivery systems including imaging capabilities for precise delivery, positioning and anchoring of the various implants are further described.

A delivery device for percutaneously delivering a stented prosthetic heart includes a sheath, a handle, and adjustment device including a fine adjustment mechanism, and an outer stability shaft. The sheath defines a lumen and is configured to compressively constrain the stented prosthetic heart valve. The handle is coupled to the proximal portion of the sheath and includes an actuator mechanism coupled to a proximal portion of the sheath that is configured to selectively move the sheath relative to the housing to release the stented prosthetic heat valve. The adjustment device is coupled to the handle and includes an adjustment lumen through which the sheath and the handle slidably extend. The outer stability shaft is coupled to the adjustment device. The fine adjustment mechanism is configured to selectively move the handle and the sheath relative to the adjustment device and the outer stability shaft.

An aortic valve implantation device that is delivered through a catheter and does not depend only on friction for fixation. In this device, multiple supporting arms (50) are provided on an intermediate portion (102) of a tubular body (105). The supporting arms are “D”-shaped after fully expansion, and are affixed between a narrowest part (73) of the aorta close to the heart and a narrowest part (74) on an aortic annulus (70), so as to achieve sufficient match between the outer surfaces of the support arms (50) and surrounding tissues; Each supporting arm (50) has three landing areas (54) and two bending sections (59). This device can accurately control the position of a valve to be released on the aortic annulus (70).

Delivery catheters for delivery of prosthetic heart valves are provided. The delivery catheters include brim recapture funnels configured for recapture of prosthetic heart valves. The brim recapture funnels are configured to recapture valve brims of partially deployed prosthetic heart valves to reduce or minimize damage to patient anatomy during a valve withdrawal procedure.

A transcatheter delivery system including an expandable transition element is disclosed. As one example, an assembly may comprise a prosthetic valve and a delivery device. The delivery device may comprise an outer shaft with a distal end portion forming a sheath adapted to enclose the prosthetic valve therein in a radially compressed configuration; an inner shaft arranged within the outer shaft and including a nosecone arranged at a distal end of the inner shaft, the nosecone arranged outside of the outer shaft, at the distal end portion of the outer shaft; and an expandable transition element adapted to expand from a non-expanded state within the outer shaft to an expanded state outside the outer shaft, wherein, in the expanded state, the transition element forms a continuous transition from the nosecone to the prosthetic valve when the sheath is moved away from the nosecone to uncover the prosthetic valve.

Expandable docking stations for docking an expandable valve can include a valve seat, one or more sealing portions, and/or one or more retaining portions. The valve seat can include radiopaque markers affixed to a frame or an impermeable member. The radiopaque markers can indicate a deployment location of the valve. The docking stations can be deployed from a catheter including one or more radiopaque markers. Relative positioning of two or more radiopaque markers can provide an indication of the amount of deployment of the docking station.

A replacement heart valve implant may include an expandable framework configured to shift from a collapsed configuration to an expanded configuration, the expandable framework having an inflow end and an outflow end, a plurality of valve leaflets secured to the expandable framework, and a plurality of pockets secured to the expandable framework in a plurality of circumferential pocket rows. The plurality of pockets extends radially outward from the expandable framework to capture retrograde fluid flow around an exterior of the expandable framework within the plurality of pockets.