A medical device and medical method. The medical device includes a flexible elongate body defining a proximal end and a distal end. The elongate body defines a first lumen spanning from the proximal end to a location proximal to the distal end. A shaping member insertable within the first lumen is included, the shaping member is configured to retain a manipulated shape when the flexible elongate body is manipulated from a first configuration to a second configuration. A tip is coupled to the distal end.

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 providing an intravascular device having a distal portion with a side port, inserting the device into the vascular lumen, positioning the distal portion in the vascular wall, directing the distal portion within the vascular wall such that the distal portion moves at least partially laterally, and directing the side port towards the vascular lumen.

A stylet for re-entry into a vessel includes an elongate body including a proximal portion, a middle curved portion, a pointed distal end, and a longitudinal axis extending through the proximal portion, the middle curved portion, and the pointed distal end. The proximal portion and the middle curved portion have substantially circular cross-sections. The middle curved portion has a pre-shaped curve along the longitudinal axis configured to match a curve of an occlusion-crossing device. The pointed distal end has an s-curve along the longitudinal axis and a flattened portion along the longitudinal axis, the flattened portion having a substantially oblong cross-section.

This disclosure is directed to systems and methods for re-entering the true lumen of a vessel. The re-entry catheters employ deflectable struts to stabilize and support the distal tip in a subintimal location while a passageway back into the true lumen is formed. Re-entry to the true lumen can be effected with a cutting element or with a conventional guidewire.

The present invention relates to a method for positioning a tip of a pacemaker lead that has passed through coronary sinus into an interventricular septum. More particularly, it relates to a method for positioning a tip of a pacemaker lead that has passed through a coronary sinus into an interventricular septum in order to more effectively transmit an electrical stimulus in a treatment using a pacemaker for patients with arrhythmia. A method of positioning a tip of a pacemaker lead, which has passed through a coronary sinus, into an interventricular septum, in order to effectively transmit electrical stimulus, includes: inserting into an intervention wire through a superior vena cava and a coronary sinus to pass through the interventricular septum and then guiding the intervention wire to an inferior vena cava; and positioning the tip of the lead into the interventricular septum by inserting the pacemaker lead along the intervention wire.

A system includes a medical device having a proximal end, a distal end, and a section of material between the proximal and distal ends. The system also includes a vascular force reduction system positioned along the section, including at least one support structure supporting at least one rotating assembly, the at least one rotating assembly having a vessel contact surface, wherein the at least one rotating assembly is configured to rotate substantially toward the proximal and the distal ends of the medical device.

An occlusion bypassing apparatus for re-entering the true lumen of a vessel after subintimally bypassing an occlusion in a vessel. The apparatus includes an outer shaft component, a needle component, and an inflatable balloon. The outer shaft component has a side port proximal to a distal end thereof and a needle lumen there-through that includes a curved distal portion that terminates at the side port of the outer shaft component. The needle component is configured to be slidably disposed within the needle lumen of the outer shaft component. The inflatable balloon includes a body portion that is disposed distal to the side port of the outer shaft component, and the body portion of the balloon has a flattened profile in an inflated state with first and second chambers that laterally extend from opposing sides of the outer shaft component for stabilizing the apparatus within a subintimal space.

Methods and devices are disclosed for passing Chronic Total Occlusion (CTO) from subintimal location and re-entry into a true-lumen of the patient using transient fenestration approach. The transient fenestration is induced by balloon dilatation within the CTO, and a guidewire quickly trails into a true lumen.

A system and method for increasing the speed of blood and wall shear stress (WSS) in a peripheral vein for a sufficient period of time to result in a persistent increase in the overall diameter and lumen diameter of the vein is provided. The method includes pumping blood at a desired rate and pulsatility. The pumping is monitored and adjusted, as necessary, to maintain the desired blood speed, WSS and pulsatility in the peripheral vein in order to optimize the rate and extent of dilation of the peripheral vein.

The present application describes an implant system useable for positioning an implant device such as a device useful for restricting passage of ingested food into the stomach. In one embodiment, the disclosed system includes a plurality of anchors that may be coupled to tissue within the stomach, or to a tissue tunnel formed by plicating stomach wall tissue. The anchor includes a loop. During use, the implant device is inserted through the loop and expanded such that it retains its position within the loop until removed. Instruments for implanting and explanting the implant device are also described.