Abstract: The techniques of this disclosure generally relate to a vector flush sizing catheter that is used initially to disperse contrast and measure a length of a main vessel using radiopaque measuring markers of the catheter. Subsequently, the vector flush sizing catheter is used to guide and introduce another endovascular device into the main vessel. By using the vector flush sizing catheter for both procedures, the exchange of catheters, the complexity of the procedure, and the associated risks are minimized.

Abstract: Devices for, and methods of, compressing a stented prosthetic heart valve are disclosed. The method including inserting a stented prosthetic heart valve having a self-expandable stent frame into a container, initiating a cooling element in the container, transferring heat through a thermal conductor to cool an interior of the container, reducing a temperature of the self-expandable stent frame while located within the container to a critical temperature of not greater than 8° C., and compressing an outer diameter of the stented prosthetic heart valve while the stented prosthetic heart valve is at the critical temperature.

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 inside 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 shaft seal or formation of multiple seals maintaining sterilizing fluid within the container so that areas underneath the shaft seal(s) can also be sterilized.

Abstract: An introducer extension with an extended, gradually curved section outside of the body enables a clinician to use an access site positioned across the body of that patient. An optional flexible or extendable section of the introducer extension allows a clinician to customize the shape of the introducer extension to a particular patient or clinician preference. The introducer extension includes a tubular sidewall extending along a longitudinal axis from a proximal end of the introducer extension to a distal end of the introducer extension and defining a lumen extending along the longitudinal axis. The tubular sidewall is configured to define a curved configuration having at least one curve between the proximal end and the distal end. The distal end is configured to couple to an introducer sheath. The lumen is configured to allow passage of a medical device.

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 balloon catheter includes an elongated catheter shaft, an expandable balloon connected to the elongated catheter shaft, and a sheath that defines a lumen and includes a therapeutic agent disposed within the lumen. The balloon catheter further includes a first configuration and a second configuration. When in the first configuration, the expandable balloon is disposed distally from the sheath such that an outer surface of the expandable balloon does not contact the lumen. Further, when in the second configuration, at least a portion of the outer surface of the expandable balloon is disposed within the lumen of the sheath such that it contacts the therapeutic agent. At least a portion of the therapeutic agent that contacts the outer surface of the expandable balloon is transferred from the lumen of the sheath to the outer surface of the expandable balloon when the balloon catheter is in the second configuration.

Abstract: Prosthetic heart valve devices and associated methods for percutaneous heart valve replacement are disclosed herein. A transcatheter valve prosthesis configured in accordance herewith includes a frame having a valve support and one or more support arms coupled thereto. The one or more support arms are configured to extend from the second end of the valve support toward the first end when the valve prosthesis is in an expanded configuration. When deployed in the expanded configuration, the one or more support arms have a curvilinear shape, such as a substantially S-shape, that at least partially engages tissue at the native heart valve.

Abstract: A transcatheter valve prosthesis including a tubular stent, a prosthetic valve component disposed within and secured to the stent, and a centering mechanism coupled to and encircling an outer surface of the tubular stent. The centering mechanism includes a self-expanding centering ring having an expanded diameter in the expanded configuration that is greater than an expanded diameter of the tubular stent in the expanded configuration and a plurality of self-expanding spokes radially extending between the tubular stent and the centering ring. The centering mechanism may include a base ring and/or a skirt. Alternatively, the centering mechanism includes a plurality of self-expanding loops. When each loop is in a delivery configuration the loop has a straightened profile that proximally extends from a proximal end of the tubular stent. When each loop is in an expanded configuration the loop has a U-shaped profile radially spaced apart from the tubular stent.

Abstract: A transcatheter valve prosthesis including a tubular stent includes an interior skirt or skirt portion is coupled to and covers an inner circumferential surface of the stent, and an exterior skirt or skirt portion is coupled to and covers an outer circumferential surface of the stent. A prosthetic valve component is disposed within and secured to the interior skirt or skirt portion. The interior and exterior skirts or skirt portions may overlap to form a double layer of skirt material on the stent, or may be portions of a skirt that do not overlap such that only a single layer of skirt material covers the stent. When the stent is in at least the compressed configuration, at least one endmost crown may be positioned radially inwards with respect to the remaining endmost crowns formed at the inflow end of the stent in order to accommodate the exterior skirt.

Abstract: Angioplasty balloons coated with at least one limus drug, which may be in crystalline form, optionally with at least one excipient, and methods for manufacturing such coated angioplasty balloons.

Abstract: A catheter assembly includes a catheter comprising a flexible elongated member including a distal portion that includes a tubular body defining an inner lumen and a plurality of body apertures that extend through a sidewall of the tubular body into the inner lumen, and a plurality of primary electrodes positioned along the tubular body. The catheter assembly includes a wire defining at least one secondary electrode, the wire being configured to be slidably moved through the inner lumen of the tubular body, where the wire and the plurality of primary electrodes are configured to electrically couple to an energy source that delivers an electrical pulse to a fluid in contact with the plurality of primary electrodes and the at least one secondary electrode to cause the fluid to undergo cavitation to generate a pressure pulse wave within the fluid.

Abstract: A system for treating valvular regurgitation in a heart valve includes a flexible canopy and an elongated tether including an elastic portion and an inelastic portion. When the system is in a deployed configuration, a proximal end of the flexible canopy is coupled to an annulus of the heart valve and a distal end of the elongated tether is coupled to a ventricle. The flexible canopy is configured to overlay a first native leaflet of the heart valve, and tension on the elongated tether is applied and/or adjusted to prevent the first leaflet from prolapsing, to maximize coaptation of the flexible canopy with a second native leaflet of the heart valve, and to minimize regurgitation of the heart valve.

Abstract: A medical device includes a body defining an exterior surface, and a coating including a therapeutic agent-containing nanoparticle disposed on the exterior surface of the medical device. The nanoparticle may include a brush-arm star polymer. The therapeutic agent may be paclitaxel.

Abstract: A catheter, such as a fractional flow reserve catheter, includes an elongate shaft having a pressure sensing wire extending to the distal portion of the elongate shaft. The wire has 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 stresses 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 stresses, the sensor is spaced apart from the pressure sensor wire to allow the pressure sensor and the pressure sensor wire to move independently from one another.

Abstract: A method of removing tissue in a body lumen includes advancing a tissue-removing catheter over a guidewire in the body lumen to position a distal end of the catheter adjacent the tissue and a proximal end portion of the catheter outside of the body lumen. The catheter includes an elongate body, a tissue removing element mounted on a distal end portion of the elongate body, and an inner liner disposed within the elongate body. The inner liner defines a guidewire lumen in which the guidewire is disposed during the advancement of the catheter. The method further includes rotating the elongate body and tissue-removing element of the catheter to remove the tissue. Detecting wear of the inner liner caused by the elongate body contacting the inner liner during use.

Abstract: A flexible, sterilizable pouch includes a first gas-impermeable web, a second gas-permeable web, and the third gas-impermeable web. The webs are arranged and sealed to form a cavity portion of the pouch and a header portion of the pouch. The header portion of the pouch is gas-permeable through the second gas-permeable web. The cavity portion of the pouch is configured to hold a medical device for sterilization and is configured to be sealed from the header portion after sterilization, thereby making the cavity portion gas-impermeable. The header is also configured to be removed from the pouch, leaving the cavity portion.

Abstract: A venous valve prosthesis includes a frame and a prosthetic valve coupled to the frame. With the venous valve prosthesis implanted in a vein, the prosthetic valve includes a closed configuration wherein an outer surface of the prosthetic valve is in contact with a wall of the vein around a circumference of the prosthetic valve to prevent blood from flowing past the prosthetic valve between the wall of the vein and the outer surface of the prosthetic valve. The prosthetic valve is configured to move to an open configuration such that at least a portion of an outer wall of the prosthetic valve partially collapses away from the wall of the vein in response to antegrade blood flow through the vein to enable blood flow between the outer surface of the prosthetic valve and the wall of the vein.

Abstract: The techniques of this disclosure generally relate to an assembly including a single multibranch stent device. The single multibranch stent device includes a main body, a proximal coupling extending radially from the main body, and a distal coupling extending radially from the main body. The main body, the proximal coupling, and the distal coupling are permanently coupled to one another and the single multibranch stent device is a single piece. By forming the single multibranch stent device as a single piece, the single multibranch stent device can be deployed in a single deployment thus simplifying the deployment procedure.

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.