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 catheter may include an elongate body including a proximal portion including a proximal end, and a distal tip portion. The distal tip portion may include an inner liner and a marker band circumferentially surrounding the inner liner. The distal tip portion also may include an outer jacket circumferentially surrounding a first portion of the inner liner and ending proximal of a proximal end of the marker band; and a tip outer jacket circumferentially surrounding a second portion of the inner liner and the marker band. The tip outer jacket extends distally past the marker band distal end to a distal tip of the elongate body, and a proximal end of the tip outer jacket may be laterally adjacent to a distal end of the outer jacket.

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: Devices, methods, and systems for prosthesis delivery to patient vasculature are provided. A prosthesis delivery device provided herein delivers a prosthesis to the vasculature of a patient and permits an operator to deploy the prosthesis using a single action mechanism to deploy the prosthesis at a standard deployment rate and a dual action mechanism to deploy the prosthesis at an accelerated deployment rate. Deploying the prosthesis at an accelerated deployment rate results in alterations to the deployed prosthesis structure because the prosthesis is deployed with increased axial compression that results in the prosthesis having increased radial force.

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 tissue-removing catheter for removing tissue in a body lumen includes an elongate body having an axis. A handle is mounted to a proximal end portion of the elongate body. A tissue-removing element is mounted on a distal end portion of the elongate body. An inner liner is received within the elongate body and defines a guidewire lumen. An advancer is mounted on the handle and is movable relative to the housing. The inner liner is coupled to the advancer at a proximal end portion of the inner liner such that movement of the advancer causes a corresponding movement of the inner liner to exert a push force on the tissue-removing element to advance the tissue-removing element and a pull force on the tissue-removing element to retract the tissue-removing element for moving the tissue-removing element relative to the handle.

Abstract: A telescoping catheter including an elongated tubular member having a proximal end, a distal end, and a passageway extending between the proximal end and the distal end. The tubular member includes a first tubular segment and a second tubular segment. The first tubular segment and the second tubular segment are slidable relative to one another to vary a length of the tubular member. The first tubular segment includes a first connector mateable with a second connector of the second tubular segment to selectively maintain the first and second tubular segments in an extended position. The second tubular segment includes a second proximal end that is mateable with a handle.

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 handle is mounted to the proximal end portion of the elongate body. The handle includes a housing enclosing components operable to cause rotation of the elongate body. A tissue-removing element is mounted on the distal end portion of the elongate body. An inner liner is received within the elongate body and defines a guidewire lumen. An advancer is mounted on the handle and is movable relative to the housing. A guide tube is mounted in the handle and is coupled to the advancer such that movement of the advancer relative to the housing causes movement of the guide tube.

Abstract: A polymer coating/ring is employed to aid in the sealing and connection of modular elements used in body flow lumens for the exclusion and bypass of diseased regions of the flow lumen, such as where aneurysm occurs adjacent to branching blood vessels.

Abstract: A debulking catheter includes an advancer for advancing a tissue-removing element, and a linear-force indicator. The linear-force indicator provides feedback to the user based on an amount of linear force being applied to the advancer.

Abstract: A loading device for loading a graft-stent into a graft cover includes an eye shaft, an adjustment shaft, a rod, and a collar. The eye shaft includes an eyelet disposed at a first end of the eye shaft. The adjustment shaft includes a first portion adjustably coupled to a second end of the eye shaft opposite the first end of the eye shaft such that an overall length of the loading device may be lengthened or shortened via the adjustment shaft. The rod is coupled to a second portion of the adjustment shaft opposite the first portion of the adjustment shaft. The collar is disposed over the rod and includes a collar lumen configured to receive a suture between an inner surface of the collar and an outer surface of the rod.

Abstract: Devices including a capsule having an interior and a clamp assembly including a plurality of clamps. Each clamp includes a first arm having a first free end and a second arm having a second free end. The device includes a clamp assembly including a compacted state in which the plurality of clamps are compressed within the capsule and a deployed state in which at least the free ends of the plurality of clamps are positioned outside of the interior of the capsule. The first free end is closer to the second free end in the compacted state as compared to the deployed state. The device can further include a push rod releasably secured to the clamp assembly and a delivery rod releasably secured to the capsule. Methods of using the devices are also disclosed.

Abstract: The present disclosure provides a tissue-removing catheter for removing tissue in a body lumen that includes an elongate body, a handle, tissue-removing element, liner assembly, and coupling assembly. The elongate body is sized and shaped to be received in the body lumen. The tissue-removing element is mounted on a distal end portion of the elongate body and removes tissue as rotated by the elongate body. The liner assembly defines a guidewire lumen. The coupling assembly is coupled to the liner assembly with a first orientation and a second orientation relative to the coupling assembly. The first orientation permits distal movement of the liner assembly relative to the coupling assembly prior to rotation of the elongate body to rotate the tissue-removing element. The second orientation is relative to the coupling assembly after rotation of the elongate body to prevent distal movement of the liner assembly relative to the coupling assembly.

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: A catheter can restore the patency of a body lumen, for example, by removing tissue from a body lumen (e.g., a blood vessel). The catheter can be a rotational catheter having a rotatable drive shaft and a tissue-removing element secured to the drive shaft to be driven in rotation by the drive shaft. The catheter can have an abrasive burr configured to abrade tissue in a body lumen. The catheter can have an expandable tissue-removing element. The catheter can include a balloon and an inflation conduit. The catheter can also be configured to move over a guidewire through a body lumen. In one embodiment, the catheter comprises an over-the-wire, balloon-expandable, rotational, and abrasive tissue-removing catheter.

Abstract: An endovascular stent graft having an oblique feature. The endovascular stent graft may include a body having a body proximal end and a body oblique perimeter distal end oblique to the body. The endovascular stent graft may further have a leg having a leg oblique proximal end oblique to the leg and a leg distal end. The endovascular stent graft may further include a plurality of stiches coupling the body oblique perimeter distal end and the leg oblique proximal end.

Abstract: A stent graft delivery system. The system includes a stent graft cover having a central longitudinal axis. The stent graft cover houses a first guidewire lumen extending along a first guidewire lumen axis and configured to track along a first guidewire. The first guidewire lumen axis is offset the central longitudinal axis. The stent graft delivery system further includes a tapered tip extending distally from the stent graft cover and defining an offset through-channel extending within the tapered tip along a tapered tip offset axis and configured to track along the first guidewire. The first guidewire lumen axis and the tapered tip offset axis extend along a common axis.

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: Devices including a capsule having an interior and a clamp assembly including a plurality of clamps. Each clamp includes a first arm having a first free end and a second arm having a second free end. The device includes a clamp assembly including a compacted state in which the plurality of clamps are compressed within the capsule and a deployed state in which at least the free ends of the plurality of clamps are positioned outside of the interior of the capsule. The first free end is closer to the second free end in the compacted state as compared to the deployed state. The device can further include a push rod releasably secured to the clamp assembly and a delivery rod releasably secured to the capsule. Methods of using the devices are also disclosed.

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.