A device and method for intravascular treatment of atherosclerotic plaque prior to balloon angioplasty which microperforates the plaque with small sharp spikes acting as serrations for forming cleavage lines or planes in the plaque. The spikes may also be used to transport medication into the plaque. The plaque preparation treatment enables subsequent angioplasty to be performed at low balloon pressures of about 4 atmospheres or less, reduces dissections, and avoids injury to the arterial wall. The subsequent angioplasty may be performed with a drug-eluting balloon (DEB) or drug-coated balloon (DCB). The pre-angioplasty perforation procedure enables more drug to be absorbed during DEB or DCB angioplasty, and makes the need for a stent less likely. Alternatively, any local incidence of plaque dissection after balloon angioplasty may be treated by applying a thin, ring-shaped tack at the dissection site only, rather than applying a stent over the overall plaque site.

A delivery system for an expandable prosthetic heart valve is provided. The delivery system includes an elongate inner member, a distal stop and a proximal stop both disposed on the elongate inner member. At least one of the proximal and distal stops is fixed to the elongate inner member. The delivery system also includes a flexible member disposed around the elongate inner member and having a distal end, a central region, and a proximal end, and an inflatable balloon disposed over the flexible member. The flexible member is configured such that when a heart valve is crimped onto the central region, the central region compresses and proximal and distal regions of the flexible member expand radially to prevent axial movement of the valve.

An inflatable balloon includes a base balloon having a cylindrical section and a conical section and at least one circumferential fiber extending circumferentially around the conical section. The inflatable balloon includes a plurality of reinforcing strips in the conical section over the at least one circumferential fiber. Each reinforcing strip includes a plurality of fibers extending at an angle relative to the at least one fiber. Each reinforcing strip is positioned a set circumferential distance away from a neighboring reinforcing strip.

An intravascular access system for facilitation of intraluminal medical procedures within the neurovasculature through an access sheath. The system includes an aspiration or support catheter having a flexible, distal luminal portion having an inner diameter defining a lumen extending between a proximal opening at a proximal end of the luminal portion and a distal opening at a distal end of the luminal portion. The catheter has a rigid spine coupled to at least the proximal end of the luminal portion and extending proximally therefrom. The system includes a dilator having a flexible, distal dilator portion sized to be received within the lumen of the luminal portion. Associated systems, devices, and methods of use are also described.

An exoskeleton device is capable of being applied to an outer surface of an elongated medical instrument, such as a catheter or a balloon (e.g., an angioplasty balloon, etc.). The exoskeleton device includes a sleeve or another element that is configured to be placed over a distal portion of the elongated medical instrument, one or more features on the sleeve or other element for performing a procedure within the body of a subject, and one or more elements that communicate with the sleeve or other element and/or the features carried thereby to enable performance of the procedure within the body of the subject. Methods of applying exoskeleton devices to elongated medical instruments and methods of using exoskeleton devices are also disclosed.

Provided herein in some embodiments is an apparatus including a composite balloon with a tubular fiber layer and a polymeric balloon layer over the fiber layer. Also provided herein in some embodiments is a method including inserting a collapsed fiber tube into an expanded polymeric balloon, expanding the collapsed fiber tube to provide an expanded fiber tube, and securing an outer surface of the expanded fiber tube to an inner surface of the expanded polymeric balloon. The method can further include inserting a distal portion of an elongate catheter body through a center of the composite balloon and securing the composite balloon to the distal portion. Thereby, the method can include forming the catheter body with the composite balloon configured to apply a pressure to surrounding walls of an anatomical vessel in an inflated state of the composite balloon to modify one or more intravascular lesions in the anatomical vessel.

A system includes a catheter and a pressure management device. The catheter includes a cuff, a resilient device, an evacuation passage, and a first fitting. The cuff defines a chamber, and has a deflated state and an inflated state. The resilient device is positioned in the chamber, and has a compressed state and an expanded state. The resilient device is configured to expand from the compressed state to the expanded state to thereby cause the cuff to move from the deflated state to the inflated state. The evacuation passage extends from the cuff to an evacuation port. The first fitting is in fluid communication with the chamber. The pressure management device includes a second fitting engaged with the first fitting, and at least one check valve in fluid communication with the second fitting. In certain embodiments, the at least one check valve includes an inlet check valve in fluid communication with the second fitting, and an outlet check valve in fluid communication with the second fitting.

A balloon is provided for selectively moving an esophagus away from an ablation site. The balloon is received through an oral cavity and into the esophagus of a patient. A deflecting member is provided in the tube, the balloon, or both, to selectively distort to bend the balloon and/or the tube to move the esophagus away from the ablation site. The deflecting member may comprise at least one of a strip made of a shape memory material that is responsive to the receipt of a stimulus to deflect to a predetermined shape, a strip that is made of or contains a ferrous material and that deflects in response to the presence of a magnetic field, and a selectively tensionable cable, wire, or string. The deflecting member may be supplemented by a stiffening strip that is located in the balloon and that causes the balloon to expand circumferentially and asymmetrically when inflated.

A pessary system for providing pelvic floor support for USL and other ligaments. The pessary has an elongated probe with independently inflatable balloons each located substantially the same distance from the insertion end of the probe and which inflate into separate radial sectors. The probe can be inserted into a vaginal cavity and the balloons inflated provide mechanical support to the USLs. Independent inflation of each balloon allows the mechanical USL support provided to be varied on left and right sides to compensate for differences in the degree of degradation and positioning of the USL ligaments on either side.

Described herein are devices and related methods for occluding at least a portion of a bodily lumen during a procedure. In some embodiments, the device includes an inner shaft defining a lumen therethrough and a first aperture; and an outer shaft including a flexible member and defining a lumen therethrough and a second aperture positioned proximally on the outer shaft relative to the flexible member. The inner shaft extends through the lumen of the outer shaft, such that at least a portion of the outer shaft is axially translatable toward and away from the distal portion of the inner shaft. The flexible member is movable between an unexpanded configuration and an expanded configuration when at least a portion of the outer shaft is translated axially toward or away from the distal portion of the inner shaft. In some embodiments, the device and methods are used for endoscopy procedures.