Abstract: Disclosed are a system and method for performing a medical procedure using direct percutaneous access of an aorta. A main sheath is introduced through an incision formed in proximity to the sternum, and positioned along (and preferable against) a posterior portion of the sternum. Instruments passed through the main sheath are used to form a purse-string suture in an exterior wall of the aorta. An opening is formed in the wall of the aorta in a region encircled by the purse-string suture, and a distal end of an introducer sheath is advanced through the opening into the aorta. A medical procedure, which may be a transcatheter aortic valve replacement, is performed using instruments passed through the introducer sheath into the aorta. After the medical procedure, the introducer sheath is withdrawn from the aorta and, as the introducer sheath is withdrawn, the purse-string suture is tightened to close the opening.

Abstract: A catheter system configured for delivering a neuromodulation therapy, includes a first therapeutic element positionable in a first target vessel selected from the group of blood vessels consisting of the superior vena cava, left brachiocephalic vein, right brachiocephalic vein, azygos vein or azygos arch, and a second therapeutic element in a second target vessel selected from the group of blood vessels consisting of the superior vena cava, left brachiocephalic vein, right brachiocephalic vein, azygos vein or azygos arch. The system and associated method deliver therapeutic energy to at least one parasympathetic nerve fiber external to the first target vessel using the first therapeutic element, and deliver therapeutic energy to at least one sympathetic nerve fiber external to the second target vessel using the second therapeutic element.

Abstract: An intestinal implant includes a proximal anchor self-expandable from a radially compressed position to a radially expandable position for engagement with a wall of the intestinal lumen and a flexible sleeve coupled to the anchor. The sleeve is implanted with the anchor downstream from the pylorus and the sleeve extending further downstream through the intestinal lumen.

Abstract: An intestinal implant includes a proximal anchor self-expandable from a radially compressed position to a radially expandable position for engagement with a wall of the intestinal lumen and a flexible sleeve coupled to the anchor. The sleeve is implanted with the anchor downstream from the pylorus and the sleeve extending further downstream through the intestinal lumen.

Abstract: Systems, devices and methods related to various heart valve implants and for delivery of those heart valve implants are described. The implants may be used to re-size a native valve annulus or to replace a native heart valve. The implants include a re-sizable frame having angled struts. Anchors secure the implant to tissue and collars are used to decrease the angle between the struts and contract the frame. The implant thus expands from a first size inside of a delivery catheter, to a second and larger deployed size inside the heart to engage and anchor with the tissue, and then to a third and contracted size to re-size the annulus and/or provide a secure fit for a replacement heart valve. Various delivery systems including imaging capabilities for precise delivery, positioning and anchoring of the various implants are further described.

Abstract: Methods related to delivery of various heart valve implants are described. The implant may be delivered using an ultrasound imaging delivery system. The ultrasound imaging delivery system may be used to deliver a variety of different devices, including mitral valve reshaping devices, mitral valve replacement valves, and others. A deployment catheter carrying an implant having a tissue anchor is advanced to a deployment site in a heart. An imaging element is positioned adjacent the implant and a relationship between the tissue anchor and an anatomical landmark in the heart is visualized. The implant is then attached by driving the tissue anchor into tissue in the heart.

Abstract: The present application describes a retention device for anchoring a medical device within the vasculature. The device may include expandable member coupled to an intravascular medical device and proportioned for receipt within a vessel. At least a portion of the expandable member is expandable to radially engage a vessel wall and to thereby retain the medical device within the vessel. The system is suitable for a variety of intravascular devices, including but not limited to ICD's, pacemakers, and intravascular drug delivery systems.

Abstract: An intravascular catheter is positionable within a blood vessel for use in transvenous stimulation of targets external to the wall of the blood vessel. The catheter includes a catheter body, a support at the distal end of the catheter body, and a plurality of electrodes carried by the support. At least a portion of the support being inflatable within the blood vessel to bias at least a portion of the plurality of electrodes into contact with the blood vessel wall.

Abstract: An intravascular electrode system includes an intravascular lead including a spiral section, and a plurality of electrodes on the spiral section. The electrodes are positioned to form a plurality of circumferentially-spaced longitudinal electrode arrays, each longitudinal array energizable independently from the other longitudinal arrays.

Abstract: A method for controlling appetite by means of a satiation device is disclosed. The device, which includes a flexible webbing defining proximal and distal openings and a biasing structure, is attached to the patient's stomach with the proximal opening positioned adjacent and below the patient's gastro-esophageal junction. The biasing structure imparts pressure against the wall of the patient's stomach adjacent the gastro-esophageal junction.

Abstract: Features for a heart valve device are described. The device may include a frame with anchors configured to secure the device to tissue. The frame may include a flared end or skirt for additional securement of the implanted device. The device may include a seal such as a barrier and/or cuff for preventing leakage. The device may contract for endovascular delivery of the device to the heart and expand for securement within the heart, such as the within the native mitral valve annulus. The device may include a replacement valve. The valve may have leaflets configured to re-direct blood flow along a primary flow axis.

Abstract: A method for controlling appetite by means of a satiation device is disclosed. The device, which includes a flexible webbing defining proximal and distal openings and a biasing structure, is attached to the patient's stomach with the proximal opening positioned adjacent and below the patient's gastro-esophageal junction. The biasing structure imparts pressure against the wall of the patient's stomach adjacent the gastro-esophageal junction.

Abstract: A device for inducing weight loss in a patient includes a tubular prosthesis positionable at the gastro-esophageal junction region, preferably below the z-line. In a method for inducing weight loss, the prosthesis is placed such that an opening at its proximal end receives masticated food from the esophagus, and such that the masticated food passes through the pouch and into the stomach via an opening in its distal end.

Abstract: A device for inducing weight loss in a patient includes a tubular prosthesis self-expandable from a collapsed position in which the prosthesis has a first diameter to an expanded position in which the prosthesis has a second, larger, diameter. In a method for inducing weight loss, the prosthesis is placed in the collapsed position and inserted into a stomach of a patient. The prosthesis is allowed to self-expand from the collapsed position to the expanded position and into contact with the walls of the stomach, where it induces feelings of satiety and/or inhibits modulation of satiety-controlling factors such as Ghrelin.

Abstract: The present disclosure includes a device for reshaping a heart valve. The device may include a central ring about a central axis and a plurality of arms coupled to the central ring, each of the arms coupled to the central ring at a pivot point at a first end of the arm, the arm comprising an attachment feature at a second point along the arm, the pivot point configured to allow movement of the arm about the pivot point through a plane extending radially from the central axis through the arm. Additionally, the plurality of arms may be contractable and may be extendable such that the hooks extend beyond a dilated heart valve. The present disclosure also includes associated methods and systems.

Abstract: A device for inducing weight loss in a patient includes a tubular prosthesis self-expandable from a collapsed position in which the prosthesis has a first diameter to an expanded position in which the prosthesis has a second, larger, diameter. In a method for inducing weight loss, the prosthesis is placed in the collapsed position and inserted into a stomach of a patient. The prosthesis is allowed to self-expand from the collapsed position to the expanded position and into contact with the walls of the stomach, where it induces feelings of satiety and/or inhibits modulation of satiety-controlling factors such as Ghrelin.

Abstract: Various methods and devices are described for retaining a medical implant within a body cavity. According to one aspect, at least a portion of a medical implant is positioned within a body cavity, and a wall of the body cavity is re-shaped such that the re-shaped wall prevents migration of the medical implant out of the body cavity. The re-shaped body wall may form a tissue pocket, tunnel, or other barrier against migration of the implant.