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 stent graft delivery system includes a stent graft and a thermal stent graft cutter for shortening the stent graft to a desired length in vivo. The thermal stent graft cutter is coupled to at least one of a stent graft cover at a distal longitudinal end of a cover body thereof, and the inner lumen tip of an inner lumen. A safety system allows activation of the stent graft cutter only when the stent graft is suitably sandwiched between the inner lumen tip and the distal end of the stent graft cover to inhibit inadvertent activation of the cutter and provide for proper cutting of the stent graft.

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.

Abstract: A heart valve therapy system including a delivery device and a stented valve. The delivery device includes an outer sheath, an inner shaft, an optional hub assembly, and a plurality of tethers. In a delivery state, a stent frame of the prosthesis is crimped over the inner shaft and maintained in a compressed condition by the outer sheath. The tethers are connected to the stent frame. In a partial deployment state, the outer sheath is at least partially withdrawn, allowing the stent frame to self-expand. Tension in the tethers prevents the stent frame from rapidly expanding and optionally allowing recapture. Upon completion of the stent frame expansion, the tethers are withdrawn.

Abstract: Prosthetic heart valve devices with tethered anchors and associated systems and methods are disclosed herein. A heart valve device configured in accordance with embodiments of the present technology can include, for example, a valve support for carrying a prosthetic valve. The valve support can be configured to be implanted at an annulus of a native mitral valve. The device can further include at least one elongated flexible member extending from the valve support in a ventricular direction, and an anchor coupled to the valve support via the elongated flexible member. The anchor can be shaped to wrap around an exterior area of an apical portion of the heart. In addition, the anchor can inhibit retrograde migration of the valve support.

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: The disclosure relates to transcatheter stented prosthesis delivery devices including a handle assembly connected to a shaft assembly on which a stented prosthesis is loaded and compressively retained with a plurality of elongate tension members. The delivery devices include a cutting assembly that can sever the elongate tension members after the stented prosthesis is expanded at a target site so that the delivery device can be withdrawn from the patient. Certain embodiments position the cutting assembly at least within the shaft assembly and others position the cutting assembly over the shaft assembly. Various disclosed cutting assemblies are actuated with the handle assembly or the like, which draw the tension members across the blade or vice versa.

Abstract: Methods, systems, devices and apparatuses to support the walls of one or more blood vessels and perfuse blood through the one or more blood vessels. The stent device allows perfusion through one or more vessels. The stent device includes a tubular member. The tubular member has a single body that includes a main body lumen, a bypass lumen and one or more branch lumens. The tubular member is configured to be inserted into the aorta. The main body lumen is configured to expand and support a vessel wall of the aorta and the one or more branch lumens are configured to connect to one or more extension grafts that extend within one or more branch vessels. The stent device includes multiple rings of stents. The multiple rings of stents are positioned within the tubular member and are configured to be expandable to expand the tubular member to support the tubular member against the vessel walls.

Abstract: A method carried out by a system configured to analyze platelet aggregation includes retaining a ferromagnetic object at an elevation of a chamber in which a sample of blood or plasma is disposed. The ferromagnetic object is retained at the elevation for a period of time. The ferromagnetic object is then released from the elevation. The ferromagnetic object minimal position is measured following the release of the ferromagnetic object. The object minimal position may be correlated with amount of platelet aggregation in the sample.

Abstract: A catheter, such as a fractional flow reserve catheter, includes an elongate shaft having a proximal end optionally coupled to a handle or luer fitting and a distal end having a distal opening. A pressure sensing wire extends to the distal portion of the elongate shaft to be coupled to a pressure sensor mounted on the distal end for measuring a pressure of a fluid within lumen of vessel. The pressure sensor wire is disposed within a pocket formed adjacent to the pressure sensor thereby minimizing the profile of the catheter. Bending or flexing stress or strain 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 or flexing stress and strain, the sensor is mounted so that the sensor is spaced apart from the elongate shaft of the catheter.

Abstract: Devices, assemblies, systems, and techniques described herein may deliver a pressure wave to structures of a heart, such an aortic valve. For example, a medical assembly may include an expandable member configured to expand from a collapsed configuration to an expanded configuration, the expandable member configured to at least partially define a channel through the expandable member in the expanded configuration and one or more electrodes carried by the expandable member. The one or more electrodes may be configured to transmit an electrical signal through a fluid to cause the fluid to undergo cavitation that generates a pressure wave within the fluid.

Abstract: A stent graft delivery system including a stent graft cover, a screw gear, and a handle assembly. The handle assembly includes an external slider, a T-tube, and a Y-adapter. The external slider is configured to rotate about the screw gear. The T-tube and the Y-adapter collectively form a hub configured to slide linearly along the screw gear as the external slider rotates. The T-tube defines a main lumen port extending therethrough and is configured to receive the stent graft cover and a main lumen. The Y-adapter defines a secondary lumen port and is configured to receive a secondary lumen.

Abstract: A prosthetic valve including an inner frame, an outer frame, and a connection assembly interconnecting the frames. The inner frame defines an interior volume for receiving a valve structure within the interior volume. The outer frame surrounds the inner frame. The inner and outer frames are each configured to be transitionable between compressed and expanded conditions. The prosthetic heart valve provides a initial deployed state in which the inner and outer frames are in the expanded condition, and a radial shape of the outer frame is adjustable via the connection assembly to a final deployed state. A shape of the outer frame can be adjusted upon implant to enable radial anchoring at the native annulus, while addressing possible non-uniformities of the native annulus and possible anatomical concerns such as LVOT obstruction.

Abstract: In some examples, a tissue compression device includes a base including a major surface configured to engage a dorsal surface of a hand of a patient, a flexible backing adjustably mechanically connected to the base and configured to engage a palmar surface of the hand when the dorsal surface of the hand is engaged with the base, and an expandable member mechanically connected to the flexible backing. The expandable member is configured to be positioned over an ulnar region of the patient when the palmar surface of the hand is engaged with the flexible backing and the dorsal surface of the hand is engaged with the base, such that inflation of the expandable member may apply pressure to tissue near the ulnar artery of the patient.

Abstract: Stented prosthetic heart valves comprising a stent frame having a compressed arrangement for delivery within a patient's vasculature and an expanded arrangement for deployment within a native heart valve. The stented prosthetic heart valves including a paravalvular leakage prevention or mitigation wrap that encircles a stent frame and is formed of a flexible material having a variable diameter defined by a greatest distance between the wrap and the stent frame. The wrap further includes a first end coupled to the stent frame and an opposing second end that is not coupled to the stent frame, wherein the wrap can selectively enlarge its diameter in situ via movement of the second end. Devices for and methods of selectively deploying the wrap are also disclosed.

Abstract: In some examples, a medical device includes a substrate defining a central port configured to provide surgical access to a surgical site opposite the substrate during a surgical procedure; and a plurality of reinforcement features disposed around the central port, wherein each reinforcement feature of the plurality of reinforcement features is configured to receive a suture, and wherein the plurality of reinforcement features are positioned to cause the substrate to tighten around the central port in response to tension being applied to ends of at least one suture connecting two or more reinforcement features.