Abstract: Devices and methods for stabilizing an electrical lead in a cardiac vein of a heart using a tether and a stent anchor. The stent anchor may include a proximal eccentric apex such that the distal electrode of the lead lies against and establishes electrical contact with tissue of the heart.

Abstract: Devices, systems and methods are described by which the blood pressure, nervous system activity, and neurohormonal activity may be selectively and controllably reduced by activating baroreceptors. A baroreceptor activation device is positioned near a baroreceptor, preferably a baroreceptor located in the carotid sinus. A control system may be used to modulate the baroreceptor activation device. The control system may utilize an algorithm defining a stimulus regimen which promotes long term efficacy and reduces power requirements/consumption. The baroreceptor activation device may utilize electrodes to activate the baroreceptors. The electrodes may be adapted for connection to the carotid arteries at or near the carotid sinus, and may be designed to minimize extraneous tissue stimulation.

Abstract: An intraoral behavior monitoring and aversion device to assist a user in quitting an undesirable behavior such as tobacco smoking, tobacco chewing, use of snuff, illicit drug use, excessive alcohol consumption, excessive food consumption, and/or other undesirable activity facilitated via the mouth. The aversion device may be wholly or partially configured to be disposed in the user's mouth, for example. The aversion device may include a detector and a output device, wherein the detector is configured to detect a parameter indicative of the user engaging in the habit or undesirable activity. If (and only if) the detector detects such a parameter, the output device may, optionally, deliver a negative stimulus to the user, thus providing negative feedback and creating an incentive for the user to limit if not eliminate the undesirable activity. The device may be configured to store and/or relay data representing sensed conditions in the mouth.

Abstract: A catheter comprises an elongate tubular member having a proximal end and a distal end, and a deflectable tip at the distal end of the elongate tubular member. The deflectable tip comprises a first helical coil having a first diameter and a second helical coil having a second diameter, the first diameter being larger than the second diameter. The first and second helical coils are arranged in the manner of a double helix. When viewed in cross-section, the first helical coil and the second helical coil are aligned at a first point on a circumference of each coil and misaligned at a second point on the circumference of each coil, where the second point is approximately 180 degrees from the first point. In certain embodiments the catheter further includes a dilatation balloon. Methods of use for crossing a chronic total occlusion are also described.

Abstract: Devices, systems and methods are disclosed by which the blood pressure, nervous system activity, and neurohormonal activity may be selectively and controllably reduced by activating baroreceptors. An intravascularly implantable medical device may include a sleeve formed at least in part of an expandable member configured to be movably attachable about at least a portion of an outer surface of an expandable intravascular stent, and one or more electrodes disposed on the sleeve and coupled to a control system and configured to selectively activate baroreceptors within a wall of a vessel when the expandable intravascular stent is implanted within the vessel.

Abstract: Devices and methods for treating a damaged intervertebral disc to reduce or eliminate associated back pain. The present invention provides disc reinforcement therapy (DRT) which involves implanting one or more reinforcement members in and preferably around the annulus of the disc. The reinforcement members may be used to stabilize the annulus and/or compresses a portion of the annulus so as to reduce a bulge and/or close a fissure. The implantable devices and associated delivery tools may incorporate heating capabilities to thermally treat the annular tissue. Alternatively or in combination, other devices may be specifically employed for such thermal treatment.

Abstract: Devices, systems and methods are disclosed by which the blood pressure, nervous system activity, and neurohormonal activity may be selectively and controllably reduced by activating baroreceptors. A baroreceptor activation device is positioned near a baroreceptor, preferably a baroreceptor located in the carotid sinus. A control system may be used to modulate the baroreceptor activation device. The control system may utilize an algorithm defining a stimulus regimen which promotes long term efficacy and reduces power requirements/consumption. The baroreceptor activation device may utilize RF-coupled or other electrodes to activate the baroreceptors. The electrodes may be adapted for connection to the carotid arteries at or near the carotid sinus, and may be designed to minimize extraneous tissue stimulation.

Abstract: An evacuation sheath assembly and method of treating occluded vessels which reduces the risk of distal embolization during vascular interventions is provided. A method of treating a lesion within a blood vessel, includes providing an evacuation sheath assembly having a multi-lumen tube with proximal and distal ends, first and second lumens therebetween, and at least one sealing surface mounted on the distal end of the multi-lumen tube. The evacuation sheath assembly is advanced to a region of interest within a blood vessel. The sealing surface is deployed upstream of the region of interest to occlude antegrade flow adjacent to the lesion to be treated. A dilation catheter is advanced through the multi-lumen tube such that the dilation balloon is positioned across the lesion and the lesion is dilated. Suction is applied to induce retrograde blood flow to carry dislodged embolic material into a lumen of the evacuation sheath assembly.

Abstract: A method and implantation tools for placing a transventricular splint including a tension member. The method includes gaining access to the patient's hearts and identifying entry or exit points for the tension member, marking those locations and delivering the tension member. Anchors for the tension member are also delivered. The length of the tensions member is measured and the walls of the heart drawn together. The pads are secured to the tension member and the tension member is trimmed to length. The pads are secured to the heart surface.

Abstract: A device for sealing a patent foramen ovale (PFO) in the heart is provided. The device includes a left atrial anchor adapted to be placed in a left atrium of the heart, a right atrial anchor adapted to be placed in a right atrium of the heart, and an elongate member adapted to extend through the passageway and connect the left and right atrial anchors. The right atrial anchor preferably includes a plurality of arms and a cover attached to the arms. The left atrial anchor also includes a plurality of arms and preferably does not include a cover. Preferably, the elongate member has a first end of fixedly connected to the left atrial anchor and a portion, proximal to the first end, releasably connected to the right atrial anchor. Preferably, the elongate member is flexible.

Abstract: Devices and methods for sealing a passageway formed by a patent foramen ovale (PFO track) in the heart are provided. One method includes providing an abrading device to the PFO track and abrading the tissue within the PFO track. The abraded tissue forming the PFO track is then held together under pressure, either via lowering right atrial pressure or via applying suction to the septum primum to pull it into apposition against the septum secundum. After a sufficient period of time, the pressure is released and the abraded tissue heals to form a robust seal over the PFO track. Additionally, several devices are provided which can be placed into the PFO track to apply adhesive to the walls of the PFO track. The devices may or may not be left within the PFO track. If the devices are not left within the PFO track, the walls of the PFO track, covered with adhesive, are brought into apposition with one another and adhered together.

Abstract: A method for treating a natural drainage passageway in a subject includes forming a cannulated artificial passageway into a subject's sinus cavity through the canine fossa region with a piercing member, the piercing member containing a hollow cannula thereon, the cannula comprising an elongate flexible member having a lumen passing therethrough. The piercing member is removed so as to leave the cannula in place. A balloon dilation catheter is then advanced within the lumen of the cannula so as to place the dilation balloon at least partially across the natural drainage passage in the sinus cavity. The dilation balloon is dilated so as to at least partially expand the natural drainage passageway.

Abstract: An evacuation sheath assembly and method of treating occluded vessels which reduces the risk of distal embolization during vascular interventions is provided. The evacuation sheath assembly includes an elongated tube defining an evacuation lumen having proximal and distal ends. A proximal sealing surface is provided on a proximal portion of the tube and is configured to form a seal with a lumen of a guided catheter. A distal sealing surface is provided on a distal portion of the tube and is configured to form a seal with a blood vessel. A method of treatment of a blood vessel using the evacuation sheath assembly includes advancing the evacuation sheath assembly into the blood vessel through a guide catheter. Prior to advancing a device across a stenosis to be treated, normal antegrade blood flow in the blood vessel proximate to the stenosis is stopped. While blood flow is stopped, the stenosis is treated.

Abstract: A steerable guide wire includes a core wire having a proximal end and a distal end. A braided filament is affixed to the distal end of the core wire. An outer coil surrounds at least a portion of the core wire and the braided filament. A proximal end of the braided filament is secured to a distal end of the coil. By locating the braided filament in the distal tip portion of the guide wire, a guide wire is provided that is highly flexible, has a high degree of tensile integrity, and is highly steerable, even in tortuous vasculature. Filter and balloon catheters having braided filaments at the distal end are also described.

Abstract: Devices, systems and methods are disclosed by which the blood pressure, nervous system activity, and neurohormonal activity may be selectively and controllably reduced by activating baroreceptors. A baroreceptor activation device is positioned near a baroreceptor, preferably a baroreceptor located in the carotid sinus. A control system may be used to modulate the baroreceptor activation device. The control system may utilize an algorithm defining a stimulus regimen which promotes long term efficacy and reduces power requirements/consumption. The baroreceptor activation device may utilize RF-coupled or other electrodes to activate the baroreceptors. The electrodes may be adapted for connection to the carotid arteries at or near the carotid sinus, and may be designed to minimize extraneous tissue stimulation.

Abstract: Devices, systems and methods are disclosed by which the blood pressure, nervous system activity, and neurohormonal activity may be selectively and controllably reduced by activating baroreceptors. A baroreceptor activation device is positioned near a baroreceptor, preferably a baroreceptor located in the carotid sinus. A control system may be used to modulate the baroreceptor activation device. The control system may utilize an algorithm defining a stimulus regimen which promotes long term efficacy and reduces power requirements/consumption. The baroreceptor activation device may utilize RF-coupled or other electrodes to activate the baroreceptors. The electrodes may be adapted for connection to the carotid arteries at or near the carotid sinus, and may be designed to minimize extraneous tissue stimulation.

Abstract: Devices, systems and methods are described by which the blood pressure, nervous system activity, and neurohormonal activity may be selectively and controllably reduced by activating baroreceptors. A baroreceptor activation device is positioned near a baroreceptor, preferably a baroreceptor located in the carotid sinus. A control system may be used to modulate the baroreceptor activation device. The control system may utilize an algorithm defining a stimulus regimen which promotes long term efficacy and reduces power requirements/consumption. The baroreceptor activation device may utilize electrodes to activate the baroreceptors. The electrodes may be adapted for connection to the carotid arteries at or near the carotid sinus, and may be designed to minimize extraneous tissue stimulation.

Abstract: A method for treating a natural drainage passageway in a subject includes forming a cannulated artificial passageway into a subject's sinus cavity through the canine fossa region with a piercing member, the piercing member containing a hollow cannula thereon, the cannula comprising an elongate flexible member having a lumen passing therethrough. The piercing member is removed so as to leave the cannula in place. A balloon dilation catheter is then advanced within the lumen of the cannula so as to place the dilation balloon at least partially across the natural drainage passage in the sinus cavity. The dilation balloon is dilated so as to at least partially expand the natural drainage passageway.

Abstract: A system for accessing a sinus cavity of a subject includes an access tool configured to penetrate into the sinus cavity from a location external the subject. The system further includes an access sheath having a distal tubular portion, a lumen extending through the access sheath and the distal tubular portion and dimensioned to receive the access tool, the distal tubular portion comprising one or more cutting surfaces disposed about an external surface thereof. The one or more cutting surfaces may include a plurality of longitudinally oriented grooves for flutes disposed about the periphery of the distal tubular member.

Abstract: Devices and methods for treating a damaged intervertebral disc to reduce or eliminate associated back pain. Dynamic bias devices and reinforcement devices are disclosed, which may be used individually or in combination, to eliminate nerve impingement associated with the damaged disc, and/or to reinforce the damaged disc, while permitting relative movement of the vertebrae adjacent the damaged disc.