Abstract: A guide extension catheter assembly including a guide extension catheter and a support device. The guide extension catheter includes a shaft and a tubular member. The support device includes a push member and a shuttle member. The guide extension catheter assembly is configured to selectively provide a delivery state in which at least a portion of the shuttle member is disposed within the lumen, a leading end of the shuttle member is distal a distal end of the tubular member, and the shuttle member is directly, physically connected to the tubular member. In the delivery state, a longitudinal distal force applied to the push member is transferred to the tubular member as a longitudinal distal force via the shuttle member. The guide extension catheter assemblies of the present disclosure can promote a two stage guide extension catheter deployment.

Abstract: Systems and methods for monitoring oxygenator performance in extracorporeal circuit systems or the like. More particularly, the disclosure relates to systems and methods including a controller programmed to determine oxygenator apparatus flow impedance as a function of an inlet pressure measurement, an outlet pressure measurement and a blood flow rate measurement. The systems and methods may include a communication device that receives signals from the controller to communicate information regarding oxygenator apparatus performance.

Abstract: A crimping device for reducing the size of prosthetic heart valve devices and other medical devices. A hydraulically operated piston advances a pusher toward an opening of a funnel. An interior surface of the funnel is configured to provide substantially uniform compression forces to a prosthetic heart valve device between the pusher and the funnel as the pusher advances the prosthetic heart valve device into the funnel. A system may comprise the crimping device and a prosthetic heart valve device positioned between the pusher and the funnel. A technique for using the crimping device includes delivering a pressurized fluid and crimping a prosthetic heart valve device using the interior surface of the funnel.

Abstract: The techniques of this disclosure generally relate to a stent-graft system including a bifurcated stent-graft, a first bifurcating branch device, and a first branch extension. The bifurcated stent-graft includes a body, a first branch limb, and a second branch limb. The first bifurcating branch device includes a body segment coupled to the first branch limb of the bifurcated stent-graft, a first branch limb, and a second branch limb. The first branch extension is within the first branch limb of the first bifurcating branch device and within an external iliac artery. The first bifurcating branch device has a wide patient applicability since the treatment can be extended proximal to the anatomical iliac bifurcation and is not limited by the common iliac artery length. The stent-graft system is suitable to treat a wide range of internal and external iliac artery diameters.

Abstract: A prolapse prevention device formed by a continuous wire-like structure having a first end and a second end disconnected from each other. The continuous wire-like structure is substantially straight in a delivery configuration. The prolapse prevention device in a deployed configuration includes a centering ring of the continuous wire-like structure configured to seat adjacent to and upstream of an annulus of a heart valve in situ, a vertical support of the continuous wire-like structure which extends from the centering ring and includes an apex configured to seat against a roof of an atrium in situ, and a leaflet backstop of the continuous wire-like structure extending radially inward from the centering ring and configured to contact at least at least a first leaflet of the heart valve in situ to exert a pressure in a downstream direction on the first leaflet to prevent the first leaflet from prolapsing into the atrium.

Abstract: An endoanchor delivery system comprising a handle system, an applier catheter, and a series of endoanchors. The applier catheter extends from the handle system and defines a lumen therein. The series of endoanchors are loaded into the lumen of the applier catheter at the distal end thereof and are disposed along a longitudinal axis of the applier catheter in a loaded state. The series of endoanchors include a first endoanchor and a second endoanchor. The first endoanchor is located distalmost the applier catheter in the loaded state. The second endoanchor is located inward the first endoanchor along the longitudinal axis of the applier catheter. The first endoanchor has a straight, flat shape in the loaded state. The first endoanchor has a helical, flat shape in a deployed state in which the first endoanchor anchors an implant to a blood vessel wall.

Abstract: Aspects of the disclosure include delivery devices for transcatheter delivery of a cardiac implant. Delivery devices can include a handle assembly as well as a piston mount connected to the handle assembly and having a distal portion terminating at a nose cap. The distal portion includes a stop extending radially from and fixed to the distal portion. The delivery device further includes a capsule assembly including a biasing element for selectively sheathing the implant and a plurality of retraction members secured about a distal end of the biasing element to control deployment of the implant. In various examples, the biasing element is a helical compression spring and the implant is a prosthetic tricuspid heart valve. Methods of loading a delivery device and delivering an implant are also disclosed.

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: A heart valve prosthesis includes a frame and a prosthetic disposed within a lumen of the frame. The frame includes a plurality of struts and crowns and has a radially collapsed state and a radially expanded state. A stiffness of the plurality of struts is varied by varying the width of at least one strut of the plurality of struts such that when the frame is in the radially expanded state, the frame has a substantially elliptical shape.

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: 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: 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 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 valve prosthesis and methods for implanting the prosthesis are provided. The prosthesis generally includes a self-expanding frame and two or more engagement arms. A valve prosthesis is sutured to the self-expanding frame. Each engagement arm corresponds to a native mitral valve leaflet. At least one engagement arm immobilizes the native leaflets, and holds the native leaflets close to the main frame. The prosthetic mitral valve frame also includes two or more anchor attachment points. Each anchor attachment point is attached to one or more anchors that help attach the valve prosthesis to the heart.

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 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: A heart valve therapy system includes 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: 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.