Abstract: An endovascular device monitoring system is provided that determines, based on movement of the endovascular device past a selected reference location, at least one of a movement rate of an endovascular device and position of a distal end of an endovascular device in a body of a patient.

Abstract: Devices for removing implanted objects from body vessels are provided. A device includes a sheath assembly having a cutting tip. The cutting tip includes a cutting surface that is adapted to cut tissue coupled to an implanted object as the cutting tip rotates. The sheath assembly further includes an outer shield carried outside of the cutting tip. The outer shield includes a distal opening, and the outer shield is translatable relative to the cutting tip from a first position to a second position and vice versa. In the first position the cutting surface of the cutting tip is disposed within the outer shield, and in the second position the cutting tip extends through the distal opening and the cutting surface is at least partially disposed outside of the outer shield.

Abstract: A method for treating a target vascular portion of a subject including: providing an angioplasty balloon system including a balloon carrying a first therapeutic agent and a second therapeutic agent on a surface of the balloon, wherein the first therapeutic agent is an anti-proliferative or anti-mitotic agent and the second therapeutic agent is a drug that aids in vascular healing on a surface of the balloon; positioning the balloon proximate the target vascular portion; expanding the balloon to engage the target vascular portion; thereby delivering at least a portion of the active agent to the target vascular portion; and withdrawing the balloon from the subject.

Abstract: Methods and systems for separating an object, such as a lead, from formed tissue are provided. Specifically, a tissue slitting apparatus is configured to engage formed tissue at a slitting engagement point. While the object is subjected to a first traction force, the tissue slitting apparatus is caused to move further into the engaged tissue and slit the tissue past the point of engagement. The slitting apparatus causes the tissue to separate along an axial direction of the length of the formed tissue and releases at least some of the force containing the object. The slitting apparatus is supported by a distal end support device configured to lock onto the lead. While supported, a slitting element of the apparatus places fibers of the formed tissue under tension and performs a lifting cut operation. The methods and systems are well suited for use in cardiac pacing or defibrillator lead explant procedures.

Abstract: Methods and devices for separating an implanted object, such as a pacemaker lead, from tissue surrounding such object in a patient's vasculature system. Specifically, the tissue separating device includes a handle, an elongate sheath and a circular cutting blade that may extend from the distal end of the sheath upon actuating the handle. The elongate sheath, particularly its distal end, includes a non-uniform wall thickness having one or more thicker portions in the outer sheath, particularly the outer cam member, and/or one or more thicker portions in an inner member disposed radially inward of the blade.

Abstract: Catheters for ablation and removal of occlusions from blood vessels are provided. Laser cutting systems and mechanical cutting systems are provided in catheter devices, the cutting systems operable to ablate, cut, dislodge, and otherwise remove occlusions within a blood vessel that may limit or prevent proper circulation. Catheters include expandable distal ends to facilitate, in some cases, relatively high bodily material removal rates compared to other devices.

Abstract: Devices for removing implanted objects from body vessels are provided. A device includes a sheath assembly having a cutting tip. The cutting tip includes a cutting surface that is adapted to cut tissue coupled to an implanted object as the cutting tip rotates. The sheath assembly further includes an outer shield carried outside of the cutting tip. The outer shield includes a distal opening, and the outer shield is translatable relative to the cutting tip from a first position to a second position and vice versa. In the first position the cutting surface of the cutting tip is disposed within the outer shield, and in the second position the cutting tip extends through the distal opening and the cutting surface is at least partially disposed outside of the outer shield.

Abstract: Devices for removing implanted objects from body vessels are provided. A device includes a sheath assembly having a cutting tip. The cutting tip includes a cutting surface that is adapted to cut tissue coupled to an implanted object as the cutting tip rotates. The sheath assembly further includes an outer shield carried outside of the cutting tip. The outer shield includes a distal opening, and the outer shield is translatable relative to the cutting tip from a first position to a second position and vice versa. In the first position the cutting surface of the cutting tip is disposed within the outer shield, and in the second position the cutting tip extends through the distal opening and the cutting surface is at least partially disposed outside of the outer shield.

Abstract: A system includes a laser catheter and a rotating optical member to receive a laser beam along an optical path and rotate to a selected position to redirect the laser beam from the optical path onto one or more selected optical fibers of a laser catheter, wherein a distal end of the laser catheter irradiates an endovascular structure.

Abstract: Embodiments of the present invention comprise a fiber optic guidewire having a hypotube with a plurality of openings that provide variable stiffness and tracking characteristics between at least one proximal segment and one distal segment of the guidewire. In some embodiments, the guidewire further comprises a mandrel disposed within the hypotube, the mandrel cooperating with the optical fibers to permit the distal end of the hypotube to be shaped as desired by a user. Methods of manufacturing and using the guidewire are also disclosed.

Abstract: A laser ablation catheter includes a distal tip, and the distal tip includes a body that defines a longitudinal axis. A first orientation indicator is formed on the body, and a second orientation indicator is formed on the body. The second orientation indicator is disposed relative to the first orientation indicator such that when the distal tip is viewed in a first side view, the second orientation indicator and the first orientation indicator overlap and visually contrast with the body. A third orientation indicator is formed on the body, and the third orientation indicator disposed relative to the second orientation indicator such that when the distal tip is viewed in a second side view, the third orientation indicator and the second orientation indicator overlap and visually contrast with the body. The second side view and the first side view are substantially 90 degrees apart about the longitudinal axis.

Abstract: A device for extending a lead according to some embodiments includes a body, a tubular member coupled to the body, the tubular member comprising an outer surface, wherein the outer surface is sized to insert into an inner lumen of a lead, the tubular member is movable between a first configuration in which the tubular member slides into the lead, and a second configuration in which at least a portion of the tubular member expands to engage an inner surface of the lead; and, an actuation mechanism operatively coupled to the tubular member, the actuation mechanism configured to move the tubular member between the first configuration and second configuration.

Abstract: The present disclosure relates generally to the use of medical devices for the treatment of vascular conditions. In particular, the present disclosure provides devices and methods for using laser-induced pressure waves created within a sheath to disrupt intimal and medial calcium within the vasculature.

Abstract: A device for extending a lead according to some embodiments includes a body, a coil element coupled to the body, the body configured to cover the coil element during use, the coil element comprising an inner lumen sized to receive an outer surface of a lead, the coil element is movable between a first configuration in which the coil element slides over the lead, and a second configuration in which at least some coils grip the outer surface of the lead; and an actuation mechanism operatively coupled to the coil element, the actuation mechanism configured to move the coil element between the first and second configurations.

Abstract: A laser catheter with a pressure sensor is provided according to embodiments of the invention. The pressure sensor may be coupled with the distal end of the laser catheter and may comprise any of various piezoelectric materials, for example Polyvinylidene Difluoride (PVDF). In various embodiments of the invention the pressure sensor is configured to detect pressure longitudinally and coaxially. The pressure sensor may provide an electric potential that is proportional to the vessel pressure and may be used to monitor and/or adjust laser parameters. In other embodiments the results from the pressure sensor may be used to determine the vessel size and/or the type of material being ablated.

Abstract: Devices for removing implanted objects from body vessels are provided. A device includes a sheath assembly having a cutting tip. The cutting tip includes a cutting surface that is adapted to cut tissue coupled to an implanted object as the cutting tip rotates. The sheath assembly further includes an outer shield carried outside of the cutting tip. The outer shield includes a distal opening, and the outer shield is translatable relative to the cutting tip from a first position to a second position and vice versa. In the first position the cutting surface of the cutting tip is disposed within the outer shield, and in the second position the cutting tip extends through the distal opening and the cutting surface is at least partially disposed outside of the outer shield.

Abstract: A laser system for use in an environment is disclosed. The laser system may include a base unit including a laser, a controller operatively coupled to the laser, and a first antenna operatively coupled to the controller. The laser system may further include a laser energy delivery system having a first end which receives laser energy from the laser and a second end which delivers the laser energy to the environment. The laser system may further include a switch unit located remote from the base unit and including a switch controller, a second antenna operatively coupled to the switch controller, and a user operable switch. The switch unit may be connected to the base unit through a tether. The controller may determine when the laser energy is provided to the laser energy delivery system based on a signal from the switch unit, the signal being sent wirelessly to the controller from the second antenna of the switch unit to the first antenna of the base unit.

Abstract: Hypo-tube based support catheter (1) for treating blood vessels, such as below the knee (BTK) blood vessels and other blood vessels (e.g., coronary, pediatric), which are partially or totally occluded. The tip of the support catheter (1) of the invention is shapeable to any desired shape before the insertion of the device into the blood vessel. The disclosed device enables improved angioplasty treatment of blood vessels, especially with a retrograde approach.

Abstract: A laser ablation catheter includes a distal tip, and the distal tip includes a body that defines a longitudinal axis. A first orientation indicator is formed on the body, and the first orientation indicator has an alphanumeric shape. A second orientation indicator is formed on the body. The second orientation indicator is disposed relative to the first orientation indicator such that when the distal tip is viewed in a first side view, the second orientation indicator and the first orientation indicator overlap, appear as the alphanumeric shape, and visually contrast with the body. The second orientation indicator is configured such that when the distal tip is viewed in a second side view, the second orientation indicator appears as the alphanumeric shape and visually contrasts with the body, the second side view and the first side view being substantially 90 degrees apart about the longitudinal axis.

Abstract: The present disclosure relates generally to the use of medical devices for the treatment of vascular conditions. In particular, the present disclosure provides devices and methods for using laser-induced pressure waves created within a sheath to disrupt intimal and medial calcium within the vasculature.