A reentry catheter for crossing a vascular occlusion includes an elongate flexible tubular body, having a proximal end, a distal end and at least one lumen extending there through. A reentry zone on the tubular body includes at least two and preferably three sets of opposing pairs of axially spaced exit apertures in communication with the lumen. The apertures are rotationally offset from each other and aligned in a spiral pattern around the tubular body. A method of crossing a chronic total occlusion includes the steps of advancing the reentry catheter across the occlusion via a channel formed in the subintimal space, and advancing a guidewire via a selected exit port into the native lumen distally of the occlusion. The catheter may be removed, leaving the guidewire across the occlusion to guide further interventional devices.

Intravascular devices and methods for intramural delivery of dissection fluids and infusates are disclosed herein. In some embodiments, the systems include an infusion assembly that can access a position in vessel adjacent an infusion site and advance a tissue manipulation component into the infusion site to deliver a therapeutic infusate. The infusion site can be an intraluminal space, such as within an obstructive material, adjacent the obstructive material, and/or within a boundary layer between the obstructive material and a vessel wall. The infusion assembly can further deliver an infusate that includes a therapeutic drug or other agent into the infusion site.

A catheter has a balloon electrode assembly with at least one compliant balloon member and at least one electrode carried on an outer surface of the balloon member for accomplishing circumferential sensing or ablation in a tubular region of the heart, including a pulmonary vein or ostium. The catheter may also include an electrode assembly with a tip and/or ring electrode distal of the balloon electrode assembly adapted for focal contact.

A system and associated method for manipulating tissues and anatomical or other structures in medical applications for the purpose of treating diseases or disorders or other purposes. In one aspect, the system includes a delivery device including a flexible portion that is suited to access target anatomy. The flexibility of an elongate portion of the delivery device can be varied. Additionally, the delivery device can include structure that maintains the positioning of the delivery device in patient anatomy.

The present disclosure is directed to a device. The device may include a distal shaft defining a central lumen and an orienting element comprising at least one inflatable member. Wherein a first portion of the orienting element extending from the shaft in a first direction and a second portion of the orienting element extending from the shaft in a second direction. Further, wherein the second direction is substantially opposite the first direction.

A catheter may be used for treating chronic venous insufficiency (CVI) by remodeling a venous valve within a vein. The catheter is advanced through the vein to a position proximate the venous valve, the catheter including a hollow needle extendable out a first side wall of the catheter and an inflatable balloon located on a second, opposing, side wall of the catheter. The inflatable balloon is inflated in order to urge the catheter towards a vessel wall opposite that of the inflatable balloon. The hollow needle is advanced at least partially into the vessel wall opposite that of the inflatable balloon and a bulking agent is injected near the venous valve in order to remodel the venous valve. The bulking agent may be injected within a subintimal space within the vessel wall, or into an advential space outside of the vessel wall.

Apparatus and methods are described, including apparatus for puncturing a fossa ovalis of a heart. The apparatus includes a catheter shaped to define a catheter lumen. A puncturing element is slidably disposed within the catheter lumen, and is deployed from a distal portion of the catheter and to puncture the fossa ovalis. A probing element is deployed from the distal portion of the catheter. Upon being deployed, the probing element probes tissue near the fossa ovalis, the probing element having a first configuration thereof upon probing the tissue near the fossa ovalis. Upon probing tissue of the fossa ovalis, the probing element facilitates positioning of the puncturing element, by automatically adopting a second configuration thereof that is different from the first configuration. Other applications are also described.

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 present disclosure is directed to a device. The device may include a distal shaft defining a central lumen and an orienting element comprising at least one inflatable member. Wherein a first portion of the orienting element extending from the shaft in a first direction and a second portion of the orienting element extending from the shaft in a second direction. Further, wherein the second direction is substantially opposite the first direction.

Disclosed are access devices that can be used to safely guide instruments, such as EP ablation catheters, to a therapy site such one within the pericardial space of the heart. The access devices include integrated visualization, illumination, stabilization, and safety features in a single platform that can, for example, more safely and efficiently identify and ablate several ventricular tachycardia (VT) locations on the left ventricle of the heart.