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 interior portions 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 mechanical seal member or formation of multiple seals so that areas proximate the seals are also sterilized during the sterilization process.

Abstract: Delivery devices for a stented prosthetic heart valve. The delivery device includes a spindle, at least one cord, and a lateral control feature. The cord is tensioned to crimp the prosthesis to a compressed condition for delivery to a target site. Tension is lessened to allow the prosthesis to self-expand. In a tethered and expanded state in which the prosthesis has self-expanded and is connected to the spindle by the cord, the lateral control feature directs the spindle to a prescribed location relative to the prosthesis appropriate for a functional evaluation of the prosthesis. In some embodiments, the spindle is directed to a center of the prosthesis; in other embodiments, the spindle is held at a commissure of the prosthesis. The lateral control features of the present disclosure assume numerous forms.

Abstract: A tissue-removing catheter for removing tissue in a body lumen includes a tube extending axially along the catheter. A junction box housing is located at a distal end of the tube. An elongate body extends distally from the junction box housing. The elongate body is sized and shaped to be received in the body lumen. A gear assembly is disposed in the junction box housing. The gear assembly engages the elongate body for rotating the elongate body. A tissue-removing element is 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.

Abstract: Delivery devices for delivering a stented prosthesis to a target site are disclosed. Certain disclosed delivery devices include a handle assembly including an actuator, a shaft assembly interconnected to the handle assembly, and are configured to releasably retain the stented prosthesis to the delivery device with at least one elongate tension member. The delivery devices further include a torque shaft that is configured to apply and adjust the amount of tension in the each tension member. For example, the torque shaft can be configured to wind and unwind each elongate tension member around the torque shaft to correspondingly compress and expand the stented prosthesis. The torque shaft can be controlled with an actuator provided in the handle assembly, for example. In some embodiments, the actuator is further configured to axially move the torque shaft.

Abstract: A tissue-removing catheter for removing tissue in a body lumen includes an elongate body having an axis, and proximal and distal end portions spaced apart from one another along the axis. The elongate body is sized and shaped to be received in the body lumen. A tissue-removing element is mounted on the 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 and defines a guidewire lumen. The inner liner is coupled to the tissue-removing element at a distal end portion of the inner liner. A coupling assembly is disposed in the tissue-removing element for coupling the inner liner to the tissue-removing element. The coupling assembly includes a bushing attached directly to the distal end portion of the inner liner.

Abstract: Distal tips for use with delivery catheters are disclosed that are configured to facilitate deflection of the catheters as they are advanced through the vasculature to a desired treatment site. Distal tips so configured realize one or more of the objectives of safer, more accurate steering of the catheter through the vasculature.

Abstract: A delivery device for implanting a prosthetic heart valve. The device includes an inner shaft assembly, an outer sheath and a connector assembly. The inner shaft assembly defines a guide wire lumen. The outer sheath is slidably received over the inner shaft assembly, and forms an exit port proximate a distal end thereof. The connector assembly establishes a guide wire passageway between the guide wire lumen and the exit port. The connector assembly is configured to permit sliding movement of the outer sheath relative to the inner shaft assembly when deploying the prosthetic heart valve. The connector assembly can include first and second tubes that are slidable relative to one another in facilitating movement of the outer sheath relative to the inner shaft assembly.

Abstract: A prosthetic heart valve including a stent frame and a valve structure. The valve structure is disposed within a lumen of the stent frame. The stent frame is configured to self-expand from a compressed condition for transluminal delivery. The stent frame has a lattice structure forming a tubular shape defining a circumference and a plurality of closed cells arranged to define a band exhibiting a variable radial stiffness. The prosthesis can be deployed such that the band applies a minimal force on to anatomical locations relating to the heart's conductive pathways. A region of the band otherwise having low radial stiffness is located at or over a conductive pathway upon final implant.

Abstract: The techniques of this disclosure generally relate to a modular stent device that is deployed into the ascending aorta via femoral access. The modular stent device is a base or anchor component to which additional modular stent devices can be attached to exclude diseased areas of the aorta while at the same time allowing perfusion of the brachiocephalic artery, the left common carotid artery, and/or the left subclavian artery.

Abstract: Bending stresses experienced by a pressure sensor mounted to a fractional flow reserve catheter when tracking the catheter through the vasculature creates a distortion of the sensor resulting in an incorrect pressure reading or bend error. In order to isolate the sensor from bending stresses, the sensor is mounted with one end coupled to the distal end of the shaft while the other end of the sensor is not coupled to the catheter so that a portion of the sensor is spaced apart from the distal end of the shaft.

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.