Abstract: In some examples, a catheter includes an elongated member including at least one balloon connected to the elongated member, the at least one balloon being configured to inflate to an expanded state. In the expanded state, the at least one balloon forms at least a portion of a cavity with a wall of a vessel of the patient. The catheter including at least one electrode carried by the elongated member and having at least one surface exposed to the cavity formed by the at least one balloon. The electrode is configured to connect to an energy source that is configured to deliver, via the electrode, an electrical signal to a fluid contained in the cavity and in contact with the electrode to cause the fluid to undergo cavitation to generate a pressure pulse wave within the fluid.

Abstract: An introducer sheath system including an outer layer, an inner layer, and a dilator is disclosed. The outer layer is circumferentially extending between a first longitudinal edge and a second longitudinal edge. An expandable gap is defined between the first and second longitudinal edges. The inner layer is disposed within the outer layer. The inner layer is configured to be continuously circumferentially expandable. The inner layer includes a non-extended state having a circumferential portion extending circumferentially inside the outer layer and a fold portion extending into an interior cavity of the inner layer. The inner layer includes an extended state wherein the fold portion extends at least partially circumferentially between the first and second longitudinal edges. The dilator is extendable longitudinally within the inner layer. The dilator includes a recess configured to accommodate the fold portion of the inner layer.

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 example method includes receiving, via at least one processor, anatomical measurements of a lumen of a patient. The method includes performing, via the at least one processor, a geometrical fit analysis based on the anatomical measurements to identify potential prostheses to be implanted in the lumen and an optimal implantation landing zone within the lumen for at least one of the potential prostheses, wherein the geometrical fit analysis includes comparing a geometry of the lumen, including shape factors for the lumen, to geometries of a plurality of candidate prostheses at a plurality of potential implant deployment positions within the lumen. The method includes performing, via the at least one processor, a biomechanical interaction analysis to select one of the identified potential prostheses based on a risk of migration within the lumen of each of the identified potential prostheses.

Abstract: A catheter for measuring a fractional flow reserve includes a proximal shaft, a distal shaft coupled to a distal portion of the proximal shaft, and a pressure sensor coupled to the distal shaft. The proximal shaft includes a distal portion configured to extend through a stenosis in a vessel. The distal portion of the proximal shaft includes a radially expanded configuration having a first diameter and a radially collapsed configuration having a second diameter, wherein the first diameter is larger than the second diameter. The distal shaft includes a guidewire lumen configured to receive therein.

Abstract: An endovascular stent graft for treatment of a blood vessel is provided. The stent is configured to be inserted into the blood vessel while in a radially-contracted configuration, and may be opened into a radially-expanded configuration once properly located within the blood vessel. The stent graft includes a main body having a proximal end and a distal end. The distal end of the main body is connected to a first leg and a second leg. A first plurality of stitching extends along a first seam path and connects the main body to the first leg, while a second plurality of stitching extends along a second seam path and connects the main body to the second leg. At least one of the first or second seam axes can be offset, in that the seam path does not extent perpendicular to a longitudinal axis of the stent graft.

Abstract: An elongate body extending from a proximal end to a distal end includes a core comprising an amorphous metal alloy and includes a sheath that comprises a crystalline metallic material. The sheath surrounds the core.

Abstract: A catheter for measuring a fractional flow reserve includes a proximal shaft, a distal shaft coupled to the proximal shaft, a pressure sensor coupled to the distal shaft, and at least one pressure sensor wire operably connected to the pressure sensor. The proximal shaft includes a radially expanded configuration and a radially collapsed configuration, wherein the proximal shaft has a first outer diameter in the radially expanded configuration and a second outer diameter smaller than the first outer diameter in the radially collapsed configuration. The distal shaft defines a guidewire lumen configured to receive a guidewire therein.

Abstract: One embodiment is directed to a system for deploying a device to a distal location across a vessel, comprising an elongate introducer sheath tubing member comprising open-cell fibrous wall material defining a lumen therethrough, wherein in a collapsed configuration the sheath has a first cross-sectional outer diameter and a first lumen inner diameter, and in an expanded configuration, the sheath has a second cross-sectional outer diameter and a second lumen inner diameter; and a substantially non-porous expandable layer coupled to a proximal portion of sheath and configured to prevent fluids present in the lumen from crossing the fibrous wall material. Also disclosed is a delivery assembly comprising an obturator which releasably captures the distal portion of an introducer sheath which obturator can be removed after the sheath is deployed to a desired location.

Abstract: Aspects of the disclosure include apparatuses for and methods of removing a ligation clip interconnecting two mitral valve leaflets. Methods can include providing a mitral valve having first and second valve leaflets interconnected with a ligation clip. The ligation clip includes a base supporting a first and second retaining arms each having an end opposite the base. The first and second valve leaflets are compressed between the first and second retaining arms. The methods further include physically separating the ligation clip from both of the first and second leaflets with the apparatus, which is configured to dislodge the first and second leaflets from the ligation clip. The apparatuses are further configured to withdraw the ligation clip from the patient along with the apparatus.

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 techniques of this disclosure generally relate to an assembly including a single branch stent device and a modular stent device configured to be coupled to the single branch stent device. The single branch stent device includes a main body and a branch coupling extending radially from the main body. The modular stent device includes a main body configured to be coupled inside of the main body of the single branch stent device, a bypass gate extending distally from a distal end of the main body of the modular stent device, and an artery leg extending distally from the distal end of the main body of the modular stent device.

Abstract: A catheter for measuring a pressure distal of a stenosis includes a shaft including a housing in a distal portion of the shaft. A flexible printed circuit board is coupled to the housing. A pressure sensor is coupled to the flexible printed circuit board and is suspended within the housing. An aperture enables blood flow into the housing and into contact with the pressure sensor.

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: 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: A medical device includes an inflatable balloon defining an interior surface and an exterior surface, and a coating including a therapeutic agent disposed on the exterior surface of the inflatable balloon. The coating has a release transition temperature within a range from about 25° C. to about 50° C. When the temperature of the coating is below the release transition temperature, the coating retains at least a portion of the therapeutic agent on the exterior of the inflatable balloon. When the temperature of the coating is above the release transition temperature, the coating releases at least a portion of the therapeutic agent from the exterior of the inflatable balloon.

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: A stent that includes a stent body and one or more weld joints, wherein the weld joints include a radiopaque material, and a method of making a stent that includes using a radiopaque filler material in a welding process.

Abstract: A stent is formed of at least a cobalt-based alloy. The cobalt-based alloy may include 10-35 weight % metal member selected from the group consisting of platinum (Pt), gold (Au), iridium (Ir), osmium (Os), rhenium (Re), tungsten (W), palladium (Pd), tantalum (Ta), and combinations thereof; 16-21 weight % chromium (Cr); 9-12 weight % molybdenum (Mo); 0-25 weight % nickel (Ni); and balance cobalt (Co). The cobalt-based alloy may be a thin outer shell of a hollow stent. The cobalt-based alloy may be used to form at least one of an inner core and an outer shell of a core-shell structure of a stent. The cobalt-based alloy may be used to form an end of a wire for forming a stent.

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.