Abstract: An apical pad for securing a prosthetic heart valve within a native valve annulus. The apical pad includes a first collar, a second collar and plurality of struts extending between the first collar and the second collar. The plurality of struts has a delivery condition in which the plurality of struts collectively form a first cross-section and a deployed condition in which the plurality of struts collectively form a second cross-section greater than the first cross-section. The apical pad may be coupled to a tether extending from a prosthetic heart valve and may transition from the delivery condition to the deployed condition by tensioning the tether.

Abstract: An adjustable implant is disclosed herein. The adjustable implant may comprise a shell including membrane and a base and having a first diameter in a plane parallel to the base. A band may be disposed within the shell. The band may have a first end and a second end connected to a spool. The band may be in a round (e.g., elliptical) configuration having a second diameter in the plane that is less than the first diameter. By wrapping the band onto the spool, the diameter of the band may be decreased and the height of the implant may be increased. By unwrapping the band from the spool, the diameter of the band may be increased and the height of the implant may be decreased.

Abstract: Artificial heart valve structures and methods of their fabrication are disclosed. The heart valve structures may be fabricated from a biocompatible polymer and include one or more heart valve leaflet structures incorporated within a conduit. The valve structures may incorporate one or more conduit sinuses, as well as a gap between the lower margin of the valve leaflets and the interior of the conduit. In addition, the valve structures may include one or more valve sinuses created in a space between the valve leaflets and the conduit inner surface. Computational fluid dynamics and mechanical modeling may be used to design the valve leaflets with optimal characteristics. A heart valve structure may also incorporate a biodegradable component to which cells may adhere The incorporated cells may arise from patient cells migrating to the biodegradable component, or the component may be pre-seeded with cells prior to implantation in a patient.

Abstract: An illustrative endoluminal implant having an elongated tubular member. The elongate tubular member having a proximal stent, a distal stent and an interconnecting sleeve. The proximal stent tapers from a first outer diameter adjacent the proximal end region to a second smaller outer diameter adjacent the distal end region. The distal stent has an outer diameter less than the first outer diameter of the proximal stent. The interconnecting sleeve is collapsible in response to an applied radial force such that the sleeve is positionable across a natural valve or sphincter.

Abstract: A prosthetic heart valve is designed to be circumferentially collapsible for less invasive delivery into the patient. At the implant site the valve re-expands to a larger circumferential size, i.e., the size that it has for operation as a replacement for one of the patient's native heart valves. The valve includes structures that, at the implant site, extend radially outwardly to engage tissue structures above and below the native heart valve annulus. These radially outwardly extending structures clamp the native tissue between them and thereby help to anchor the prosthetic valve at the desired location in the patient.

Abstract: The present disclosure relates to drug eluting stents, methods of making, using, and verifying long-term stability of the drug eluting stents, and methods for predicting long term stent efficacy and patient safety after implantation of a drug eluting stent. In one embodiment, a drug eluting stent may include a stent framework; a drug-containing layer; a drug embedded in the drug-containing layer; and a biocompatible base layer disposed over the stent framework and supporting the drug-containing layer. The drug-containing layer may have an uneven coating thickness. In addition or in alternative, the drug-containing layer may be configured to significantly dissolve/dissipate/disappear between 45 days and 60 days after stent implantation. Stents of the present disclosure may reduce, minimize, or eliminate patient risks associated with the implantation of a stent, including, for example, restenosis, thrombosis, and/or MACE.

Abstract: Luminal grafts and methods of making and using the same. An exemplary luminal graft of the present disclosure is configured as a generally tubular element configured for nerve cells to grow therethrough and comprises at least one sheet of biological tissue having elastin fibers and collagen fibers, with the elastin fibers being a dominant component thereof; and a plurality of microchannels formed on a surface of the at least one sheet of biological tissue, each of the microchannels extending longitudinally between a first end and a second end of the at least one sheet of biological tissue and configured to provide intraluminal structural guidance to nerve cells proliferating therethrough.

Abstract: A prosthetic heart valve may include a valve portion, a tether connected to the valve portion, and an anchor for connecting the tether to the wall of the heart. The anchor may include a flexible first disc biased toward a first shape that is convex in a first direction and a neck extending from the first disc in a second direction opposite the first direction. The neck has a first end connected to the first disc and a second end. The anchor may further include a flexible second disc connected to the second end of the neck and biased toward a second shape that is convex in the first direction. When deployed, the first and second discs sandwich the wall of the heart.

Abstract: A valved conduit including a bioprosthetic aortic heart valve connected to a tubular conduit graft forming an ascending aorta. The conduit graft may attach to the heart valve in a manner that facilitates a redo operation in which the valve is replaced with another valve. A sewing ring may be pre-attached to the inflow end of the graft, and then the valve connected to a delivery holder advanced into the graft and secured to the sewing ring. Dry bioprosthetic valves coupled with conduit grafts sealed with a bioresorbable medium can be stored with the delivery holder.

Abstract: A transcatheter atrio-ventricular valve prosthesis for functional replacement of an atrio-ventricular heart valve in a connection channel, the prosthesis comprising a radially expandable tubular body extending along an axis, and a valve arranged within and attached to the tubular body. The tubular body is provided with an outer circumferential groove which is open to the radial outside of the tubular body, whereby the tubular body is separated by the outer circumferential groove into first and second body sections. The tubular body is provided with a first plurality of projections which extend from the first or second body section in an axial direction of the tubular body and each of which has a free end arranged to overlap the outer circumferential groove. An elongate outer member may be disposed at the exterior of the connection channel wall structure at a level of the circumferential groove.

Abstract: A prosthetic implant transfer device is provided that may be used to insert a prosthetic implant through a surgical opening. In some embodiments, the device may comprise a flexible sheet of material that may be formed into an elongated hollow structure. The flexible sheet of material includes a plurality of fasteners that may be selected and engaged to define a desired size distal opening.

Abstract: Prosthetic valved conduits are provided that include a leaflet construct coupled between two portions of a conduit. Each leaflet has a free edge and a leaflet attachment edge. The leaflet attachment edge is disposed between a first conduit distal end and a second conduit proximal end that are coaxial therebetween defining a junction.

Abstract: An interbody fusion cage having upper and lower canals for receiving the heads of bone screws that have been pre-installed in opposing vertebral body endplates. The proximal wall of the cage preferably has a vertical slot that communicates with each canal and is adapted to allow access by a screwdriver and tightening of the screws.

Abstract: A stented valve including a stent structure including a generally tubular body portion having a first end, a second end, an interior area, a longitudinal axis, and a plurality of vertical wires extending generally parallel to the longitudinal axis around a periphery of the body portion, wherein the plurality of vertical wires includes multiple commissure wires and at least one structural wire positioned between adjacent commissure wires, and a plurality of V-shaped wire structures having a first end, a second end, and a peak between the first and second ends, wherein a first end of each V-shaped structure extends from a first vertical wire and a second end of each V-shaped structure extends from a second vertical wire that is adjacent to the first vertical wire, wherein each V-shaped structure is oriented so that its peak is facing in the same direction relative to the first and second ends of the body portion, and a valve structure including a plurality of leaflets attached to the stent structure within the

Abstract: Apparatus, systems, and methods for inserting prosthesis implants into surgically-created implant pockets in a subject and for preventing capsular contracture resulting from surgical insertion of prosthesis implants. The apparatus includes a base having an upper surface and a lower surface and having an aperture formed therein which extends through the upper surface and the lower surface of the base. The apparatus also includes a tubular member that is coupled to the base. The inner bore of the tubular member is operable to receive the implant and has a substantially uniform cross-sectional width over the predetermined length. The apparatus is capable of shielding the implant from microbial contamination, including contamination by the endogenous flora of the subject, during insertion of the implant into the surgically-created implant pocket.

Abstract: A lubricated tubular graft is implanted in the inferior vena cava and the superior vena cava in order to control the inflow of blood to the right atrium. A bifurcated leg with a non-collapsing stent extends across the tricuspid valve. A bioprosthetic valve is positioned proximal of the stent in the bifurcated leg in order to regulate flow through the tricuspid valve and to eliminate tricuspid regurgitation.

Abstract: A method is provided for implanting a valve having at least one valve leaflet within the cardiovascular system of a subject. One step of the method includes preparing a substantially dehydrated bioprosthetic valve and then providing an expandable support member having oppositely disposed first and second ends and a main body portion extending between the ends. Next, the substantially dehydrated bioprosthetic valve is attached to the expandable support member so that the substantially dehydrated bioprosthetic valve is operably secured within the main body portion of the expandable support member. The expandable support member is then crimped into a compressed configuration and placed at a desired location within the cardiovascular system of the subject. Either before or after placement at the desired location, fluid or blood re-hydrates the substantially dehydrated bioprosthetic valve.

Abstract: A cardiac valve prosthesis including an armature for anchorage of the valve prosthesis at an implantation site. The armature defining a lumen for the passage of the blood flow and having a longitudinal axis, and a set of prosthetic valve leaflets supported by said armature and configured to move, under the action of blood flow, in a radially divaricated condition to enable the flow of blood through said lumen in a first direction, and in a radially contracted condition, in which said valve leaflets co-operate with one another and block the flow of blood through the prosthesis in the direction opposite said first direction.

Abstract: A method is provided, including treating a heart valve of a patient by implanting at the heart valve an implant including an elongate element including at least in part a tension element, by placing the implant at the heart valve of the patient, and subsequently to the placing, increasing tension of the elongate element at least in part. The tension element is configured to undergo conformational changes, subsequently to the placing, responsively to a cardiac cycle of the patient. Implanting the implant includes implanting the implant such that the tension element undergoes the conformational changes responsively to the cardiac cycle of the patient in a manner in which the tension element cyclically increases and decreases pressure applied to at least one leaflet of the heart valve by the elongate element.

Abstract: An annuloplasty device is disclosed comprising first and second support rings having a coiled configuration, and respective first and second retention units, the first support ring transitions to the second support ring over a transition section, the transition section is adapted to be arranged at a commissure of the heart valve leaflets, the first and second support rings extend in respective first and second coil planes being essentially perpendicular to the central axis, the transition section bends at least partly along the central axis so that the first coil plane is separated a distance from the second coil plane along the central axis at the transition section.