Abstract: A prosthetic valve including an inner frame, an outer frame, and a connection assembly interconnecting the frames. The inner frame defines an interior volume for receiving a valve structure within the interior volume. The outer frame surrounds the inner frame. The inner and outer frames are each configured to be transitionable between compressed and expanded conditions. The prosthetic heart valve provides a initial deployed state in which the inner and outer frames are in the expanded condition, and a radial shape of the outer frame is adjustable via the connection assembly to a final deployed state. A shape of the outer frame can be adjusted upon implant to enable radial anchoring at the native annulus, while addressing possible non-uniformities of the native annulus and possible anatomical concerns such as LVOT obstruction.

Abstract: Stented prosthetic heart valves comprising a stent frame having a compressed arrangement for delivery within a patient's vasculature and an expanded arrangement for deployment within a native heart valve. The stented prosthetic heart valves including a paravalvular leakage prevention or mitigation wrap that encircles a stent frame and is formed of a flexible material having a variable diameter defined by a greatest distance between the wrap and the stent frame. The wrap further includes a first end coupled to the stent frame and an opposing second end that is not coupled to the stent frame, wherein the wrap can selectively enlarge its diameter in situ via movement of the second end. Devices for and methods of selectively deploying the wrap are also disclosed.

Abstract: In some examples, a tissue compression device includes a base including a major surface configured to engage a dorsal surface of a hand of a patient, a flexible backing adjustably mechanically connected to the base and configured to engage a palmar surface of the hand when the dorsal surface of the hand is engaged with the base, and an expandable member mechanically connected to the flexible backing. The expandable member is configured to be positioned over an ulnar region of the patient when the palmar surface of the hand is engaged with the flexible backing and the dorsal surface of the hand is engaged with the base, such that inflation of the expandable member may apply pressure to tissue near the ulnar artery of the patient.

Abstract: In some examples, a medical device includes a substrate defining a central port configured to provide surgical access to a surgical site opposite the substrate during a surgical procedure; and a plurality of reinforcement features disposed around the central port, wherein each reinforcement feature of the plurality of reinforcement features is configured to receive a suture, and wherein the plurality of reinforcement features are positioned to cause the substrate to tighten around the central port in response to tension being applied to ends of at least one suture connecting two or more reinforcement features.

Abstract: The techniques of this disclosure generally relate to an iliac branch device having an external iliac body, a common iliac branch, and an internal iliac branch. A diameter of the proximal opening of the common iliac branch is greater than a diameter of a distal opening of the external iliac body. The iliac branch device is configured to be deployed without going up and over the aortic bifurcation and without using some form of supra-aortic antegrade access such as through brachial or axillary artery access. This simplifies the procedure and reduces procedure time thus maximizing the success rate of the procedure and allows the procedure to be performed on a broad patient population.

Abstract: A delivery system for delivering an endovascular graft within a blood vessel. The delivery system includes a tip assembly including a tip and a sleeve having a proximal end. The delivery system includes a tip capture mechanism. The tip assembly is configured to move axially relative to the tip capture mechanism and between a delivery position and a release position. The tip capture mechanism includes a landing zone. The delivery system includes a travel limiter configured to align the proximal end with the landing zone when the tip assembly is in the release position to facilitate removal of the delivery system from the blood vessel.

Abstract: A branchable stent graft including a tubular body and stents attached to and supporting the tubular body. The tubular body extends along a longitudinal axis and includes proximal and distal ends. The stents include first and second stents. The stents circumferentially extend around the tubular body. The first and second stents are spaced apart along the longitudinal axis of the tubular body. The first stent includes alternating crests and troughs forming peaks and valleys therebetween. The tubular body includes access regions arranged circumferentially spaced around the tubular body. The access regions are confined within the peaks and/or valleys of the first stent. The access regions include peripheries defining openings covered with graft material regions.

Abstract: A delivery system for a prosthetic valve device includes a first shaft including an outflow capture device mounted on a distal end thereof, a second shaft slidingly disposed over the first shaft and including an inflow capture device mounted on a distal end thereof, and a retractable sheath slidingly disposed over the second shaft to hold the prosthetic valve device in a radially compressed configuration for delivery to a body lumen. The inflow capture device is configured for releasable engagement through openings in a plurality of first attachment members on the device. The outflow capture device is configured for releasable engagement through openings in a plurality of second attachment members on the device.

Abstract: An introducer sheath system including an outer layer, an inner layer, and a dilator is disclosed. The outer layer is circumferentially extending between a first longitudinal edge and a second longitudinal edge. An expandable gap is defined between the first and second longitudinal edges. The inner layer is disposed within the outer layer. The inner layer is configured to be continuously circumferentially expandable. The inner layer includes a non-extended state having a circumferential portion extending circumferentially inside the outer layer and a fold portion extending into an interior cavity of the inner layer. The inner layer includes an extended state wherein the fold portion extends at least partially circumferentially between the first and second longitudinal edges. The dilator is extendable longitudinally within the inner layer. The dilator includes a recess configured to accommodate the fold portion of the inner layer.

Abstract: 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.

Abstract: A stent-graft prosthesis includes a graft material having a tubular construction, a frame coupled to the graft material, and a port or opening disposed between a proximal end and a distal end of the graft material. The port or opening is open during deployment of the stent-graft prosthesis to enable blood flow from a graft lumen within the graft material to exit the graft lumen, and the port or opening is blocked upon full deployment of the stent-graft prosthesis to prevent blood flow from within the graft lumen from exiting the graft lumen through the port or opening.

Abstract: A stent in a radially compressed configuration includes a plurality of first outer crowns and a plurality of second outer crowns, each of the first outer crowns and the second outer crowns connected by a strut of a plurality of struts. The plurality of first outer crowns and the plurality of second outer crowns are disposed at a crown angle in the range of about 15 degrees to about 35 degrees, the crown angle being defined by a line extending through a midpoint of a crown of the plurality of first outer crowns or the plurality of second outer crowns through a center of radius of the crown with respect to a line that is parallel to a central longitudinal axis of the stent.

Abstract: In one aspect, a medical balloon assembly includes a tip sleeve secured to the distal end portion of a balloon catheter that includes the distal neck of a balloon. The tip sleeve has at least an inner layer and an outer layer. The inner layer is formed from a bondable material that is directly bondable to the exterior of the distal neck portion of the balloon. The tip sleeve is bonded directly to the distal neck of the balloon. The outer layer is formed from a lubricious polymer. Such a medical balloon assembly is made by receiving the distal neck inside the proximal end portion of the tip sleeve and directly bonding the distal neck of the balloon to the inner layer of the tip sleeve.

Abstract: Embodiments hereof relate methods of delivering a valve prosthesis to an annulus of a native valve of a heart. A valve delivery system is introduced into a ventricle of the heart via a ventricular wall of the heart. The valve delivery system has a displacement component at the distal portion thereof. The valve prosthesis is in a delivery configuration and the displacement component is in a delivery state in which the displacement component has a first outer diameter. While the valve prosthesis is in the delivery configuration, the displacement component of the valve delivery system is radially expanded into an expanded state in which the displacement component has a second outer diameter greater than the first outer diameter. The valve delivery system is advanced towards the annulus of the native valve of the heart with the displacement component in the expanded state to displace chordae tendineae.

Abstract: A continuous wire stent includes a wire bent into a waveform and spirally wrapped into a helix having a plurality of bands that form a hollow cylindrical shape. The waveform includes a plurality of waves, each wave including a first outer crown including a first intrados, a second outer crown including a second intrados facing the first intrados, a first mid-crown disposed between the first outer crown and the second outer crown, a second mid-crown disposed between the second outer crown and an outer crown of a next wave of the waveform, a first strut connecting the first outer crown to the first mid-crown, a second strut connecting the first mid-crown to the second outer crown, a third strut connecting the second outer crown to the second mid-crown, and a fourth strut connecting the second mid-crown to the outer crown in the next wave of the waveform.

Abstract: A tissue-removing catheter for removing tissue in a body lumen includes an elongate body and a tissue-removing element mounted on a distal end portion of the elongate body. The tissue-removing element is configured to remove the tissue as the tissue-removing element is rotated by the elongate body within the body lumen. An inner liner is received within the elongate body. The inner liner defines a guidewire lumen. The inner liner isolates an interior of the guidewire lumen from the elongate body and tissue-removing element such that rotational forces are not transferred from the elongate body and tissue-removing element to the interior of the guidewire lumen when the elongate body and tissue-removing element are rotated during removal of tissue from the body lumen.

Abstract: Delivery devices for delivery of a stented prosthetic heart valve. Various delivery devices include an outer sheath assembly including an outer sheath connected to a capsule that is advanced proximally to retain the prosthetic valve, which is secured over an inner shaft assembly of the delivery device. The delivery device further includes a bumper to provide a smooth transition of the capsule over the prosthetic valve during loading and recapture procedures. The bumper is expandable from a first position to a second position in which a distal end of the bumper is expanded to increase its diameter. The bumper can be biased in the second, expanded position so that the bumper automatically transitions to the expanded position upon retraction of the outer sheath.

Abstract: A crimping device for reducing the size of prosthetic heart valve devices and other medical devices. A hydraulically operated piston advances a pusher toward an opening of a funnel. An interior surface of the funnel is configured to provide substantially uniform compression forces to a prosthetic heart valve device between the pusher and the funnel as the pusher advances the prosthetic heart valve device into the funnel. A system may comprise the crimping device and a prosthetic heart valve device positioned between the pusher and the funnel. A technique for using the crimping device includes delivering a pressurized fluid and crimping a prosthetic heart valve device using the interior surface of the funnel.

Abstract: A “dry” packaging in which a prosthetic heart valve is packaged within a container with hydrogel that can be provided in many forms. Certain embodiments include hydrogel that is preloaded with glycerol or the like. The hydrogel regulates the humidity within the container through a diffusion-driven mechanism if a gradient of humidity between the inside and the outside of the hydrogel exists. Humidity regulation is important to prevent the tissue of the valve structure from drying out. When the partially-hydrated hydrogel is present within container, which is saturated with air of a predefined humidity, the water molecules from the air will be absorbed by the hydrogel if the air humidity is high (i.e. when the thermodynamics favor hydrogel hydration) or vice versa. Various embodiments are configured to also house at least a portion of a delivery device for delivering the prosthetic heart valve.

Abstract: Delivery devices for a stented prosthetic heart valve. The delivery device includes a spindle, at least one cord, and a covering feature associated with the spindle for selectively covering at least a portion of a stented prosthetic heart valve tethered to the spindle in a delivery state. In some embodiments, the covering feature includes a tip mounted to the spindle. The tip can include an overhang region for selectively covering a portion of the stented prosthetic heart valve. In other embodiments, the tip can include a tip body and a compressible foam bumper. In yet other embodiments, the covering feature includes an outer sheath arranged to selectively cover the stented prosthetic heart valve. The outer sheath can be elastic and stretchable for recapturing a partially expanded prosthesis, for example by including one or more windows covered by a stretchable covering layer.