Abstract: Systems and methods for building a landing zone for an endovascular procedure are described. This procedure is “hybrid” in that it involves both direct access (e.g., sternotomy or partial sternotomy) to the site for installation of the landing zone, as well as endovascular installation of a TAVR or TEVAR device (e.g., stent graft) once the landing zone is installed. The landing zone is installed by wrapping a landing band around a portion of a vessel. The landing band may be selected to be fixed at a diameter so that it inhibits any expansion of the vessel, and also supports a later-installed TAVR or TEVAR device. The TAVR or TEVAR device is then endovascularly delivered to the vessel and deployed therein. The device expands until it contacts the vessel, which is supported from the outside by the landing band, which thus constrains and supports the device from outside.

Abstract: A stent graft delivery system and method of assembling the same is disclosed. The stent graft delivery system includes a stent graft cover configured to maintain a stent graft in a constricted configuration, and is configured to slide relative to the stent graft to enable the stent graft to expand radially outwardly. The stent graft cover extends along a first central axis. A tapered tip defining an opening therethrough is configured to track along a guidewire. The opening extends along a second central axis that is offset from the first central axis. This provides a delivery system with an opening in a leading edge that is not center relative to the outer stent graft cover.

Abstract: A prosthesis fastener applier includes a handle, a plurality of input controls, and a fastener delivery shaft. The handle contains a motor and a control circuit. The input controls are connected to the handle and communicatively connected to the control circuit. The fastener delivery shaft includes a fastener cartridge and a driver shaft. The fastener cartridge includes a plurality of internal threads configured to receive a plurality of helical fasteners in stacked relationship. The driver shaft is operatively connected to the motor, disposed within the fastener cartridge, and configured to pass through respective inner diameters of the helical fasteners. The control circuit is configured to control the motor in response to signals from one or more of the input controls to rotate the driver shaft to cause one or more of the helical fasteners to be advanced axially relative to the fastener cartridge.

Abstract: A prosthesis retaining assembly for securing an implantable prosthesis to a catheter assembly can include a first member including a prosthesis retaining slot configured to retain a portion of the prosthesis. The retaining slot can have a first portion with a first width and a second portion with a second width. The first portion can be distal to the second portion. The second width can be larger than the first width, and the retaining slot can have an opening at a first surface of the first member. The prosthesis retaining assembly can also include a second member configured to be move relative to the first member. The second member can be configured to move to a position that obstructs a portion of the opening of the retaining slot.

Abstract: An example technique of forming a package includes retaining a package precursor in a support. The package precursor includes a shrink-formable composition and defines an interior volume configured to enclose a component, such as a medical supply. The package may be formed by at least directing a flow of heated medium from a nozzle toward at least one region of the package precursor to cause the at least one region to shrink faster than an adjacent region of the package precursor. In some examples, an example system for shrink-forming a package includes the support and the nozzle.

Abstract: An example medical system includes a medical device configured to join the edges of the leaflets together, an elongate body configured to be navigated through vasculature to a heart valve of patient, and a plurality of tissue engagement devices extending from a distal end of the elongate body, each tissue engagement device comprising at least one clamp configured to capture leaflets of the heart valve.

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 catheter may include an elongate body extending from a proximal end to a distal end and defining a lumen; a push member mechanically coupled to the proximal end of the elongate body; and a slidable push grip disposed about an outer perimeter of the push member. The slidable push grip is controllably engageable with the push member. When the slidable push grip is in an engaged state with the push member, the slidable push grip transmits an axial force to the push member to enable the push member to transmit the axial force to the elongate body. When the slidable push grip is in a disengaged state with the push member, the slidable push grip is movable axially in at least one direction along a length of the push member while transmitting substantially no axial force to the push member.

Abstract: A crimper includes a first arm that includes a first crimper die that defines a first tapered channel. The crimper also includes a second arm coupled to the first arm at a pivot connection. The second arm includes a second crimper die that defines a second tapered channel. The pivot connection enables the first arm and the second arm to rotate about the pivot connection from an open state to a closed state. The first arm and second arm rotate at an angle relative to one another to allow loading of the expandable medical device into the first tapered channel or the second tapered channel and to allow positioning of the expandable medical device relative to a delivery device. When transitioning, the first tapered channel and the second tapered channel form a chamber that is configured to crimp the expandable medical device from the uncompressed state to the compressed state.

Abstract: In some examples, a delivery device includes a handle that includes a control member, an elongate body, a plurality of arms extending from a distal portion of the elongate body to a distal collar configured to releasably couple to an annuloplasty device. The plurality of arms is operatively coupled to the control member and configured to position the annuloplasty device at a target site in a patient. The delivery device further comprises a plurality of anchors configured to secure the annuloplasty device to tissue at the target site, each respective anchor of the plurality of anchors deployable from a respective arm of the plurality of arms.

Abstract: A balloon catheter includes a balloon coupled to a shaft. The shaft includes a proximal perfusion portion disposed proximal of the balloon and a distal perfusion portion disposed distal of the balloon. The proximal and distal perfusion portions each are formed by a respective plurality of wire members woven together to form a respective proximal and distal braided shafts. The plurality of wire members are woven together such that a plurality of perfusion openings are formed between the wire members. The plurality of perfusion openings extend from an outer surface of the respective proximal or distal braided shaft to a lumen of the respective proximal or distal braided shaft. A perfusion lumen extends between the proximal perfusion portion and the distal perfusion portion.

Abstract: A guide extension catheter includes a push member and a distal shaft coupled to and extending distally from the push member. The distal shaft includes a shaft wall and a passageway. The shaft wall includes a helically-shaped proximal end and a distal end. The helically-shaped proximal end coils helically about a first central longitudinal axis of the passageway of the distal shaft. The helically-shaped proximal end of the shaft wall defines a helically-shaped entry port of the distal shaft. The distal shaft may include a helically-shaped collar coupled to the helically-shaped proximal end of the distal shaft, the collar defining the helically-shaped entry port of the distal shaft.

Abstract: A system for fracturing a frame of a deployed prosthesis with ultrasonic vibration includes a shaft, a tip assembly, an ultrasonic electric generator, and an ultrasonic transducer. The shaft includes a proximal portion and a distal portion. The tip assembly is coupled to the distal portion of the shaft. The tip assembly includes a cutting edge. The ultrasonic transducer is electrically coupled to the ultrasonic generator. Ultrasonic vibration generated by the ultrasonic transducer is translated to the tip assembly. The cutting edge of the tip assembly is configured to focus the vibration of the tip assembly onto a frame of a deployed prosthesis to fracture the frame of the prosthesis. The ultrasonic transducer may be coupled to the proximal portion or the distal portion of the shaft.

Abstract: In some examples, a catheter may include an elongate body and a push assembly. The elongate body may include an inner liner defining an entry port into a lumen defined by the elongate body, and an outer jacket. The push assembly may an anchor member positioned at a distal end of an elongate member. Distal to a proximal end of the elongate body, a first portion of the push assembly, comprising the anchor member, may be positioned between a portion of the inner liner and a portion of the outer jacket. The anchor member may extend only partially around an outer perimeter of the inner liner when the catheter is assembled. Proximal to the proximal end of the elongate body, a second portion of the push assembly, proximal to the first portion, may be positioned outside of the outer jacket and the inner liner.

Abstract: A prosthetic assembly configured for endovascular placement within an aortic arch and method of use thereof. The prosthetic assembly includes a proximal aortic stent-graft prosthesis configured to be positioned within a proximal portion of the aortic arch adjacent to the brachiocephalic artery, a distal aortic stent-graft prosthesis configured to be positioned within a distal portion of the aortic arch adjacent to the left subclavian artery, a first branch stent-graft prosthesis configured to be positioned within the brachiocephalic artery and a second branch stent-graft prosthesis configured to be positioned in one of the left common carotid and the left subclavian artery. When deployed, a proximal end of the first branch stent-graft prosthesis is disposed within a lumen of the proximal aortic stent-graft prosthesis to proximally displace the ostium of the brachiocephalic artery.

Abstract: A tool for use in loading a transcatheter valve prosthesis within a delivery catheter includes a body portion, a pivotable element and a biasing element. The body portion includes a central passageway extending form a proximal end to a distal end of the body portion. The central passageway is configured to receive a distal portion of a delivery catheter therethrough. The pivotable element is attached to the body portion and is configured to secure a tether during loading of a transcatheter valve prosthesis within the delivery catheter. The biasing element compresses the pivotable element against the body portion such that the pivotable element holds a second end against the delivery catheter and secures the tether thereto. The pivotable element may be two or more pivotable elements.

Abstract: Biodegradable magnesium alloy implantable medical devices are protected to delay onset of corrosion, and thus biodegradability, or to corrode more uniformly. The protection allows for extended effective use of the devices while maintaining biodegradability. Examples of protective coatings include conversion coatings that at least partially remove exposed second phases from a surface of the magnesium alloy and coatings that provide a barrier between water and the surface of the magnesium alloy.

Abstract: An expandable introducer sheath provided with a steering mechanism is disclosed. The introducer sheath is configured for providing a prosthesis delivery system percutaneous access to a patient's vasculature. The introducer sheath includes a sheath component defining a central lumen and having a longitudinally-extending, radially-expandable portion. The sheath component also includes a steering wire slidably disposed within a wall thereof that longitudinally extends along the radially-expandable portion. When the steering wire is in a slackened configuration, the steering wire permits a width of the radially-expandable portion to increase. When the steering wire is in a taut configuration, the steering wire permits a distal portion of the sheath component to be manipulated or bent in order to align a distal port of the introducer sheath, for instance, with an ostium of a branch vessel.

Abstract: In some examples, the disclosure describes an annuloplasty device that comprises a tube-like structure configured to extend around at least part of a circumference of an annulus of a cardiac or vascular valve of a patient, and at least one anchor configured to anchor the tube-like structure to the annulus. The tube-like structure is configured to decrease a distance between valve leaflets that extend from the annulus.

Abstract: A stent graft includes a main body extending along a longitudinal axis when in a preinstalled configuration prior to insertion into a body of a patient. The stent graft also includes a mobile external coupling extending away from the main body and configured to align with a secondary blood vessel within the body to provide access thereto. The main body includes a plurality of stents extending thereabout. The stents include a first bracketing stent extending about a proximal side of the mobile external coupling, and a second bracketing stent located adjacent the first bracketing stent and extending about a distal side of the mobile external coupling. The first bracketing stent includes peaks that are aligned along a first axis, and the second bracketing stent includes peaks that are aligned along a second axis that diverges from the first axis relative to a circumferential direction toward the mobile external coupling.