Vascular access devices, systems, and methods of their use are provided. In one embodiment, a vascular access device includes a catheter, a balloon, and an inflation lumen. The catheter includes an elongate flexible shaft having a proximal end and a distal end with a primary lumen therethrough. The balloon is disposed about the distal end of the catheter. The inflation lumen is in fluid communication with the balloon and extends toward the proximal end of the shaft of the catheter. The balloon is inflatable into a shape having a first open end, a second open end, a sidewall between the first and second open ends, and a passageway therethrough, which, when the balloon is deployed and inflated within a vessel, permits blood flowing in the vessel to flow through the passageway. The balloon further includes a balloon lumen which is coupled at its first end to the primary lumen of the catheter and which extends to an aperture in the sidewall of the balloon, thereby providing a hemostatic connection and luminal access to a wall of the vessel via the primary lumen of the catheter.

Devices and methods for the treatment of chronic total occlusions are provided. One disclosed embodiment comprises a method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein. The method includes inserting an intramural crossing device into the vascular lumen, positioning at least the distal tip of the crossing device in the vascular wall, advancing an orienting device over the crossing device such that an orienting element of the orienting device resides in the vascular wall, inserting a reentry device, and re-entering the true vascular lumen.

A fixation device for securing together leaflets of a heart valve is provided. The fixation device may comprise two plates that are disposed on either side of the tricuspid valve. The plates may be secured to one another by a locking clip, thereby securing the valve leaflets between the plates.

A tissue marker assembly which can be useful with an implant delivery system for delivering a sheet-like implant is disclosed. The tissue marker assembly can include a delivery sleeve with a tissue marker slidably disposed within a lumen therethrough. A proximal handle can be coupled to the tissue marker and delivery sleeve, having a first part and a second part. The second part of the proximal handle can be releasably attached to the tissue marker proximal end so that the second part can be removed to allow the delivery sleeve to be removed proximally over the tissue marker after it is affixed to tissue. The distal portion of the marker can include a plurality of longitudinally extending arms when unconstrained project outward from the shaft to retain the marker's position in tissue.

A heart valve therapeutic device has an elongate anchor wherein the anchor has a stiffness to hold its shape and location to support the valve element. The anchor may have a stylet or a shaped or stiff collar arranged to provide a desired shape to the anchor and it may be lockable. A prosthetic valve element has leaflets and is supported on the anchor by coupler at a desired location. There is an actuator for changing relative axial position of the proximal and distal couplers on the anchor. The anchor stiffness may be sufficient to provide sufficient support to resist axial forces from the ventricle in use without necessarily having a fixing element engaging heart tissue. The prosthetic leaflets may extend proximally and radially outwardly, so that there is excellent co-apting of the native leaflets (NL) against the prosthetic leaflets.

The invention generally relates to catheter systems and methods for guided formation of vascular access sites (such as fistulas and grafts). According to certain aspects, a catheter system for forming a vascular access site include an elongate body comprising a distal end and configured to be inserted into a first vessel. The elongate body includes an exit port along its side that is proximal to the distal end. An imaging assembly is associated with the elongate body and configured to generate image data of the first vessel and a second vessel positioned next to the first vessel. For vascular access formation, a penetrating member of the catheter system extends out of the exit port and through a wall of the first vessel and a wall of the second vessel.

An atherectomy system that utilizes an anchoring balloon with a rotary debulker and a crossing balloon to remove or debulk lesions formed on the interior wall surface of a body vessel. The system may include a first balloon coupled to a first tubular member, a rotary debulker coupled to a second tubular member, a second balloon coupled to both the third tubular member and the axially moveable fourth tubular member such that the second balloon is disposed inside the third tubular member. Methods for operating this device are also provided.

The embodiments presented herein relate to concepts designed to eliminate the gap between a catheter and guide wire that can otherwise contribute to a catheter getting stuck within the vasculature.

An embolus trap device is provided. The embolus trap device consists of an outer catheter, an inner catheter, a plurality of filter baskets, and a plurality of basket collapse wires. The filter baskets are of different radius and are positioned along the inner catheter in order of increasing radius from the proximal to the distal end. The filter baskets increase in radius so that any embolic fragment that flows past each basket has a chance to be caught and secured by a filter basket distal to it. The filter baskets are separately collapsible by the plurality of collapse wires and are collapsed in proximal-to-distal fashion with the largest basket being closed last in order to capture embolic fragments that may emerge from the smaller baskets because of disruptions as they are closed.

A balloon suction catheter may be used to remove clots and increase blood flow to obstructed vessels such as a cerebral artery in a stroke patient. The catheter may be used to apply suction on the clot while providing flow arrest, embolic protection, and optionally flow reversal. The same catheter may also be used to provide for a flow modulation procedure known as post-conditioning to potentially reduce any damage from the sudden reintroduction of blood flow reperfusion injury.