Abstract: A delivery system for percutaneously delivering a heart valve prosthesis to a site of a native heart valve includes a delivery catheter and a heart valve prosthesis. The delivery catheter includes an outer sheath, an inner shaft, and an orifice restriction mechanism. The heart valve prosthesis has a valve member and a docking member. When the orifice restriction mechanism is positioned within the docking member within an annulus of the native heart valve, the orifice restriction mechanism temporarily replicates the operation of the native heart valve until the valve member is positioned within the docking member.

Abstract: A delivery device for delivery and deployment of a heart valve prosthesis with a torque anchoring mechanism includes a balloon having a shaped surface configured to engage a corresponding shaped surface of the heart valve prosthesis. The balloon is configured to rotate about a central longitudinal axis of the delivery device to rotate the heart valve prosthesis.

Abstract: A delivery system for prosthetic medical devices. The delivery system may include a delivery system configured to be driven between a containment configuration and a deployment configuration. The delivery system may be configured to cause relative motion between a delivery capsule and a prosthetic device within the delivery capsule. The delivery system may include a first fluid pathway and a second fluid pathway and may be configured to switch between the first fluid pathway and the second fluid pathway as the delivery system transitions toward a deployment configuration. The delivery system may include a recapture circuit configured to enable the delivery system to recapture a prosthetic device using the delivery capsule.

Abstract: A guidewire includes an elongated member and a shaft extending distally from the elongated member, wherein the elongated member and shaft are configured to be navigated through vasculature of a patient. The guidewire further includes a first conductor extending around the shaft to define an outer perimeter of the guidewire and a first electrode adjacent the shaft. The first conductor is configured electrically connect the first electrode to an energy source. The guidewire further includes a second electrode and a second conductor configured to electrically couple the second electrode to the energy source. The first and second electrodes may be configured to deliver an electrical signal to fluid contacting the first and second electrodes to cause the fluid to undergo cavitation to generate a pressure pulse wave within the fluid.

Abstract: A valve delivery system and valve delivery method are disclosed. The valve delivery system includes an inner shaft extending along a longitudinal axis and an elongated tension member to continuously circumferentially coil around a prosthetic valve disposed on the inner shaft to form a sheath portion to releasably contain the prosthetic valve on the inner shaft in a compressed state, the elongated tension member extending from the sheath portion along the longitudinal axis of the inner shaft.

Abstract: The techniques of this disclosure generally relate to a modular stent device including a main body configured to be deployed in the ascending aorta, a bypass gate configured to be deployed in the aorta, and a bifurcated contra limb. The bifurcated contra limb includes a single proximal limb that is bifurcated (split) into a first distal limb and a second distal limb. By forming the bifurcated contra limb to include a single proximal limb that is bifurcated into the distal limbs, guiding a guide wire into the relatively larger opening of bifurcated contra limb at a proximal end is simpler than guiding a guidewire into two smaller limbs extending distally from main body. Accordingly, cannulation of the bifurcated contra limb is relatively simple thus simplifying the procedure. In addition, the parallel design mimics anatomical blood vessel bifurcations to limit flow disruptions.

Abstract: A tissue-removing catheter for removing tissue in a body lumen includes a catheter body assembly having an axis and proximal and distal end portions spaced apart from one another along the axis. At least a portion of the catheter body assembly is sized and shaped to be received in the body lumen. A handle is mounted to the proximal end portion of the catheter body assembly and operable to cause rotation of the catheter body assembly. The handle includes internal handle components that interface with the catheter body assembly. The internal handle components provide at least four interface locations spaced axially along the catheter body assembly. A tissue-removing element is mounted on the distal end portion of the catheter body assembly. The tissue-removing element is configured to remove the tissue as the tissue-removing element is rotated by the catheter body assembly within the body lumen.

Abstract: In some examples, a catheter includes one or more balloons positioned between an inner wall and an outer wall of an elongated body of the catheter. The one or more balloons are configured to expand through one or more inner wall openings defined by the inner wall and into an inner lumen of the catheter, as well as through one or more outer wall openings defined by the outer wall, e.g., to extend radially away from an outer surface of the outer wall of the catheter. In some examples, the one or more balloons are configured to expand radially inward through the one or more inner wall openings and into the inner lumen of the catheter to contact (e.g., directly contact) a guidewire positioned within the inner lumen.

Abstract: In some examples, a catheter flaring device includes a housing and a pin. The housing includes an interior surface defining a cavity configured to receive at least a portion of a catheter having an entry port and engage an exterior surface of the catheter proximate the entry port. The pin is configured to be advanced into the entry port of the catheter to increase a cross-sectional dimension of the entry port. Flaring the entry port may help reduce catching of a medical device on the entry port of the catheter during a medical procedure.

Abstract: The techniques of this disclosure generally relate to an assembly including a single branch stent device and a modular stent device configured to be coupled to the single branch stent device. The single branch stent device includes a main body and a branch coupling extending radially from the main body. The modular stent device includes a main body configured to be coupled inside of the main body of the single branch stent device, a bypass gate extending distally from a distal end of the main body of the modular stent device, and an artery leg extending distally from the distal end of the main body of the modular stent device.

Abstract: Numerous delivery devices for delivery of a stented prosthesis, such as a stented prosthetic heart valve. Various delivery devices include a capsule that is advanced proximally to retain the stented prosthesis, which is secured over an inner shaft assembly of the delivery device. The delivery device further includes a bumper or bumper assembly to provide a smooth transition of the capsule over the stented prosthesis. In some alternate disclosed embodiments, the bumper further serves to connect various elements of the inner shaft assembly. Additional embodiments include a bumper assembly arranged and configured to longitudinally expand and contract to substantially fill any open space as the capsule is retracted from the stented prosthesis, which prevents kinking in the capsule. Additional embodiments include proximal and/or distal bumpers for temporarily covering and smoothing the ends of the stented prosthesis as part of a delivery device that does not include a capsule.

Abstract: Embodiments hereof relate to a delivery system for a transcatheter valve prosthesis, the delivery system having an integral centering mechanism to circumferentially center both the delivery system and the valve prosthesis within a vessel at the target implantation site. The centering mechanism may include expandable wings that may be selectively aligned with openings formed through a sidewall of an outer shaft of the delivery system, a coiled wing that may be selectively exposed through an opening formed through a sidewall of an outer shaft of the delivery system, a plurality of elongated filaments extending through a plurality of lumens of an outermost shaft of the delivery system that may be selectively deployed or expanded, an outer shaft that includes at least one pre-formed deflection segment formed thereon, a tool having a deployable lever arm, and/or a plurality of loops deployable via simultaneous longitudinal and rotational movement.

Abstract: Methods of deploying and securing a heart valve prosthesis are disclosed. A heart valve prosthesis having a plurality of anchor guides is loaded within a catheter-based delivery device, wherein each of the anchor guides is releasably engaged by a respective elongate member and wherein tensioning of the elongate members aids in collapsing the prosthesis during loading. The delivery device is advanced via a transcatheter procedure to position the heart valve prosthesis at an implantation site. The heart valve prosthesis undergoes controlled deployment by controlling the release of tension on the elongate members. After deployment of the heart valve prosthesis, an anchor tool is advanced along at least one elongate guide member to the anchor guide associated therewith and positioned at a securement site. When the securement site is reached, an anchor clip is released from the anchor tool to secure the prosthesis to the heart.

Abstract: A heart valve prosthesis includes a frame and a prosthetic disposed within a lumen of the frame. The frame includes a plurality of struts and crowns and has a radially collapsed state and a radially expanded state. A stiffness of the plurality of struts is varied by varying the width of at least one strut of the plurality of struts such that when the frame is in the radially expanded state, the frame has a substantially elliptical shape.

Abstract: The present disclosure pertains to crosslinkable compositions and systems as well as methods for forming crosslinked compositions in situ, including the use of the same for controlling the movement of bodily fluid within a patient, among many other uses.

Abstract: A modular valve prosthesis includes an inflow stent, a valve component including a valve stent and a prosthetic valve, and an outflow stent. In a radially compressed delivery configuration, an inflow end of the valve stent is separated from an outflow end of the inflow stent and an outflow end of the valve stent is separated from an inflow end of the outflow stent. In a radially expanded deployed configuration, the inflow end of the valve stent is in contact with the outflow end of the inflow stent and the outflow end of the valve stent is in contact with the inflow end of the outflow stent. A delivery system includes a capsule including first, second and third sections and flexible first and second bands between respective sections. The modules of the modular valve prosthesis are aligned with the sections and gaps between the modules are aligned with the bands.

Abstract: The techniques of this disclosure generally relate to a vector flush sizing catheter that is used initially to disperse contrast and measure a length of a main vessel using radiopaque measuring markers of the catheter. Subsequently, the vector flush sizing catheter is used to guide and introduce another endovascular device into the main vessel. By using the vector flush sizing catheter for both procedures, the exchange of catheters, the complexity of the procedure, and the associated risks are minimized.

Abstract: Devices for, and methods of, compressing a stented prosthetic heart valve are disclosed. The method including inserting a stented prosthetic heart valve having a self-expandable stent frame into a container, initiating a cooling element in the container, transferring heat through a thermal conductor to cool an interior of the container, reducing a temperature of the self-expandable stent frame while located within the container to a critical temperature of not greater than 8° C., and compressing an outer diameter of the stented prosthetic heart valve while the stented prosthetic heart valve is at the critical temperature.

Abstract: Aspects of the disclosure relate to “wet” transcatheter prosthetic heart valve or other implant packaging and assemblies in which a prosthetic heart valve or other implant is loaded into a first portion of a delivery device and positioned within a container in which sterilizing fluid is retained to sterilize inside of the container as well as provide moisture to prevent the implant from drying out. The disclosure also relates to methods of sterilizing the disclosed assemblies. Some disclosed methods include at least two sterilizing steps and adjustment of a shaft seal or formation of multiple seals maintaining sterilizing fluid within the container so that areas underneath the shaft seal(s) can also be sterilized.

Abstract: An introducer extension with an extended, gradually curved section outside of the body enables a clinician to use an access site positioned across the body of that patient. An optional flexible or extendable section of the introducer extension allows a clinician to customize the shape of the introducer extension to a particular patient or clinician preference. The introducer extension includes a tubular sidewall extending along a longitudinal axis from a proximal end of the introducer extension to a distal end of the introducer extension and defining a lumen extending along the longitudinal axis. The tubular sidewall is configured to define a curved configuration having at least one curve between the proximal end and the distal end. The distal end is configured to couple to an introducer sheath. The lumen is configured to allow passage of a medical device.