Abstract: A delivery system includes an elongated shaft component, a self-expanding valve prosthesis, at least one cinching suture, and a radially-expandable sleeve. The valve prosthesis is disposed over a distal portion of the elongated shaft component and includes a compressed configuration for delivery and an expanded configuration for deployment. The at least one cinching suture removably couples the valve prosthesis to the elongated shaft component and radially compresses the valve prosthesis into the compressed configuration for delivery. The sleeve is secured to and encircles an outer surface of the valve prosthesis. The sleeve has a delivery state with a first diameter extending over a full length of the valve prosthesis in the compressed configuration and a deployed state with a greater second diameter extending over the full length of the valve prosthesis in the expanded configuration. The sleeve is configured to prevent paravalvular leakage in situ in the deployed state.

Abstract: A transcatheter prosthesis with radially compressed and expanded configurations. An elongate member encircling at least a portion of the prosthesis, and configured to provide a seal between the prosthesis and a native anatomy when the prosthesis is deployed in the radially expanded configuration. The elongate member may be a resilient elongate member having a radially contracted state, when in tension, to hold at least the portion of the prosthesis in the radially compressed configuration, and having a radially expanded state, when relaxed, to provide the seal between at least the portion of the prosthesis and a native anatomy when the prosthesis is deployed. A system for delivering the transcatheter prosthesis may include a delivery catheter having an elongate cinching member encircling at least a second portion of the prosthesis, wherein the elongate cinching member is configured to hold the second portion of the prosthesis in the radially compressed configuration.

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, and an outer jacket. The push assembly may an elongate member extending from a proximal portion to a distal portion, where a cross-section of the distal portion is D-shaped and tapers in a distal direction. Distal to a proximal end of the elongate body, a first portion of the elongate member may be positioned between a portion of the inner liner and a portion of the outer jacket, and proximal to the proximal end of the elongate body, a second portion of the elongate member may be positioned outside of the outer jacket and the inner liner.

Abstract: Delivery devices and methods for delivering a stented prosthesis to a target site are disclosed. Disclosed delivery devices include a handle assembly including an actuator, an inner 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 tension management device that is configured to limit the amount of tension that can be applied via the actuator to the at least one tension member. Certain embodiments are configured to apply different tension limits to different tension members that are controlled by a one or more actuators. Other various embodiments include one or more tension adjustors to selectively adjust one or more tension limits.

Abstract: Systems and methods for determining modified fractional flow reserve values of vascular lesions are provided. Patient physiologic data, including coronary vascular information, is measured. According to the physiologic data, a coronary vascular model is generated. Lesions of interest within the coronary vascular system of the patient are identified for modified fractional flow reserve value determination. The coronary vascular model is modified to generate modified blood flow information for determining the modified fractional flow reserve value.

Abstract: A package includes a tray and a cover configured to seal an open end of the tray when the cover is assembled onto the tray. The tray has a flange extending about a periphery at the open end of the tray. A continuous barrier seal is formed between the flange and the cover when the cover is assembled onto the tray, and a discontinuous sacrificial seal is also formed between the flange and the cover when the cover is assembled onto the tray. The discontinuous sacrificial seal is configured to absorb stress applied to the flange. The continuous barrier seal is disposed closer to an inner periphery of the flange than the discontinuous sacrificial seal. Holes are formed on the corners of the flange, and the holes are spaced apart from the discontinuous sacrificial seal.

Abstract: The present disclosure provides a catheter including a plurality of a segments, each segment having a stiffener extending along its length. The plurality of segments are interconnected with connectors such that each of the segments can bend in multiple planes via rotation of the connectors.

Abstract: A method includes hermetically sealing a medical device within a pouch, the pouch including peeling panels that are free from one another. The pouch is placed within a tray and the peeling panels are attached to unloading handles of the tray. The unloading handles are releasably coupled together. The method further includes simultaneously separating the unloading handles and the peeling panels to open the pouch and expose the medical device for removal thereof.

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: Transcatheter delivery systems, delivery catheters and associated methods for percutaneous delivery of prosthetic mitral valves using a retrograde approach are disclosed herein. A heart valve delivery system configured in accordance herewith includes a delivery catheter having an elongated tubular component and an articulation assembly at a distal end thereof. The articulation assembly includes an arm portion coupled to the tubular component by an elbow or hinge portion. In a closed, delivery state, the elbow portion positions the arm portion generally parallel to the tubular component for delivery of the delivery catheter through the vasculature. In an open, deployed state, the elbow portion positions the arm portion in a non-axial direction with respect to a longitudinal axis of the tubular component for orienting and positioning a prosthetic valve device carried by the arm portion, e.g., within the native mitral valve region.

Abstract: A catheter is disclosed that allows selective direction of a surgical tool into multiple blood vessels of a patient. The catheter includes a catheter body that has a main exit port and a side exit port. An internal balloon is provided within the catheter body. The internal balloon is inflatable, and can be located at or near a distal portion of the side exit port. When deflated, the internal balloon allows the surgical tool to advance past the side exit port and out the main exit port. When inflated, the internal balloon directs the surgical tool to advance out the side exit port instead of the main exit port.

Abstract: The present disclosure relates to numerous delivery devices and methods for transcatheter prosthetic heart valve loading, deployment and delivery utilizing at least one suture. Disclosed delivery devices utilize improved suture routing methods and configurations that reduce suture tangling and also provide the ability to adjust the prosthetic heart valve expansion and contraction prior to the final release of the prosthetic heart valve from the delivery device.

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: 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: 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.