Abstract: A system and method for extracting a pVAD device that is implanted with a distal portion in an aorta of the heart and a drive line extending across an inter-atrial septum and out of the body via a superior vessel of the venous vasculature, include a first device that is introduced into a femoral artery and through the descending aorta used to engage a distal part of the pVAD device in the aorta of a patient using an instrument. A second, cutter, device is introduced into the venous vasculature superior to heart, advanced to a position adjacent the inter-atrial septum, and used to cut the pVAD drive line adjacent to the inter-atrial septum. After cutting, a first portion of the pVAD is withdrawn from the body via the venous vasculature, and a second portion is withdrawn from the body via the femoral artery.

Abstract: A system and method used to deliver a therapeutic device to a target treatment site in the heart includes a cable percutaneously introduced a cable into a vasculature of a patient and positioned to run from a femoral vein, through the heart via a transseptal puncture, and to a femoral artery. The therapeutic device is passed over an end of the cable at the venous side and is secured to the cable. The therapeutic device is pushed in a distal direction while the second end of the cable is pulled in the proximal direction to advance the therapeutic device to the target treatment site. A left ventricle redirector aids in orienting the therapeutic device and preventing migration of the cable towards delicate mitral valve structures and chordae tendoneae during advancement of the therapeutic device.

Abstract: Percutaneous access sheaths used to provide access to the vasculature and heart for the introduction of percutaneous ventricular assist devices (pVADs), and to remain in place for the duration of pVAD use. The sheaths include actively closeable seals engageable to seal against the drive lines of the pVADs to minimize blood loss during pVAD use.

Abstract: A system and method for extracting a pVAD device that is implanted with a distal portion in an aorta of the heart and a drive line extending across an inter-atrial septum and out of the body via a superior vessel of the venous vasculature, include a first device that is introduced into a femoral artery and through the descending aorta used to engage a distal part of the pVAD device in the aorta of a patient using an instrument. A second, cutter, device is introduced into the venous vasculature superior to heart, advanced to a position adjacent the inter-atrial septum, and used to cut the pVAD drive line adjacent to the inter-atrial septum. After cutting, a first portion of the pVAD is withdrawn from the body via the venous vasculature, and a second portion is withdrawn from the body via the femoral artery.

Abstract: A system and method used to deliver an aortic valve therapeutic device to an aortic valve site includes a cable percutaneously introduced a cable into a vasculature of a patient and positioned to run from a femoral vein, through the heart via a transseptal puncture, and to a femoral artery. The therapeutic device is passed over an end of the cable at the venous side and is secured to the cable. The therapeutic device is pushed in a distal direction while the second end of the cable is pulled in the proximal direction to advance the therapeutic device to the mitral valve site. A left ventricle redirector aids in orienting the therapeutic device and preventing migration of the cable towards delicate mitral valve structures and chordae tendoneae during advancement of the therapeutic device.

Abstract: A neuromodulation system includes a first therapy element adapted for positioning within a superior vena cava, and a second therapy element adapted for positioning within a pulmonary artery. The first therapy element is carried on a first elongate flexible shaft, and the second therapy element is carried on a second elongate flexible shaft. One of the first and second shafts is slidably received within a lumen of the other of the first and second shafts—so that the second therapy element may be advanced within the body relative to the first therapy element. A stimulator is configured to energize the first therapy element within the first blood vessel to deliver therapy to a first nerve fiber disposed external to the superior vena cava and to energize the second therapy element within the pulmonary artery to deliver sympathetic therapy to a second nerve fiber disposed external to the pulmonary artery.

Abstract: A method for delivering a therapeutic device to a target aortic valve site includes transseptally positioning a cable to run between a femoral artery, through the heart via an aortic valve, left ventricle, mitral valve, left atrium, and right atrium into the venous vasculature, the flexible member having a first end extending outside the body from a venous vessel superior to the heart and a second end external to the patient at the femoral artery. The aortic valve therapeutic device is attached to the cable outside the body and introduced into a femoral artery. A steerable sheath is advanced over the cable, into the venous vasculature and into the left ventricle of the heart. The aortic valve therapeutic device is pushed in a distal direction from the femoral artery while the cable is pulled from the venous vessel to advance the aortic valve therapeutic device to the target site.

Abstract: A system and method used to deliver a percutaneous ventricular assist device (pVAD) or other cardiac therapeutic device to a site within the heart, such as a site at the aortic valve. A flexible device is percutaneously introduced into a vasculature of a patient and positioned to run from a femoral vein, through the heart via a transseptal puncture, and to a femoral artery. The venous-side end of the flexible device is withdrawn out the venous vasculature superior to the heart, and a pVAD is secured to the flexible device. The pVAD is pushed in a distal direction while the arterial-side end of the flexible device is pulled in the proximal direction to advance the pVAD to the target site. A left ventricle redirector aids in orienting the pVAD and preventing migration of the flexible member towards delicate structures of the heart during advancement of the pVAD.

Abstract: An instrument for facilitating transseptal delivery of a cardiac therapeutic device is positionable in a left ventricle. The instrument includes an elongate shaft having a tubular lumen, the shaft having a proximal portion and a distal portion actively steerable between a generally straight position and a curved position. An external pull wire and an internal pull wire are each actuatable to move the distal portion to the curved position. The external pull wire extends internally through the proximal portion of the shaft and longitudinally along the exterior of the distal portion of the shaft, while the internal pull wire extends internally through the proximal portion of the shaft adjacent to the external pull wire, and extends internally through the distal portion of the shaft.

Abstract: A conduit for creating a passage from a right atrium to a left atrium, through a mitral valve into the left ventricle, and to provide a passage from the left ventricle into the aortic valve. The conduit includes an elongate tubular member having a shaft with a proximal section and a distal loop section at a distal end of the proximal section. The distal loop section includes a proximal curve, a distal curve, a generally straight segment extending between the curves, and a distal tip. The shaft in the distal loop section curves back on itself so that proximal curve is formed by a part of the shaft that is closer along the length of the shaft to the distal tip.

Abstract: A system and method used to deliver a percutaneous ventricular assist device (pVAD) or other cardiac therapeutic device to a site within the heart, such as a site at the aortic valve. A flexible device is percutaneously introduced into a vasculature of a patient and positioned to run from a femoral vein, through the heart via a transseptal puncture, and to a femoral artery. The venous-side end of the flexible device is withdrawn out the venous vasculature superior to the heart, and a pVAD is secured to the flexible device. The pVAD is pushed in a distal direction while the arterial-side end of the flexible device is pulled in the proximal direction to advance the pVAD to the target site. A left ventricle redirector aids in orienting the pVAD and preventing migration of the flexible member towards delicate structures of the heart during advancement of the pVAD.

Abstract: A method of treating a patient having a blood pressure comprises delivering neuromodulation therapy to sustain or increase the blood pressure. The neuromodulation therapy includes placing a sympathetic therapy electrode in a posterior portion of a blood vessel and stimulating at least one extravascular cardiac sympathetic nerve fiber using said electrode.

Abstract: A system for use in transseptally delivering a cardiac therapeutic device (“CTD”) to a target site in the heart, includes a CTD having an elongate flexible advancer on its distal end, and a flexible member proportioned for introduction into a vasculature and having a length to extend from the right subclavian vein, through the heart via a transseptal puncture, and to a femoral artery such that a first end of the flexible member is external to the patient at the right subclavian vein or other venous access site and a second end of the flexible member is external to the patient at the femoral artery. The flexible member has a grasper releasably engageable with the advancer.

Abstract: A system and method used to deliver a therapeutic device to a target treatment site in the heart includes a cable percutaneously introduced a cable into a vasculature of a patient and positioned to run from a femoral vein, through the heart via a transseptal puncture, and to a femoral artery. The therapeutic device is passed over an end of the cable at the venous side and is secured to the cable. The therapeutic device is pushed in a distal direction while the second end of the cable is pulled in the proximal direction to advance the therapeutic device to the target treatment site. A left ventricle redirector aids in orienting the therapeutic device and preventing migration of the cable towards delicate mitral valve structures and chordae tendoneae during advancement of the therapeutic device.

Abstract: A system for use in performing aortic valve procedures using an instrument disposed through an aortic arch includes a lubricious track positionable within the aortic arch such that a lubricious inferior surface of the track is exposed to the interior of the aortic arch. An instrument to be used in performing the valve procedure is configured to be percutaneously introduced into a femoral artery, advanced through the descending aorta and into the aortic arch, and moved into sliding contact with the lubricous inferior surface of the track. The instrument is advanceable along the lubricious surface until its distal portion is at a target site for the aortic valve procedure.

Abstract: 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.

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: The present invention provides for methods and compositions for treating and/or preventing cardiac dysfunction by administering to subject a therapeutically effective amount of a bisphosphonate, functional analogue or a pharmaceutically effective salt thereof.

Abstract: A neuromodulation system includes a first therapy element adapted for positioning within a superior vena cava, and a second therapy element adapted for positioning within a pulmonary artery. The first therapy element is carried on a first elongate flexible shaft, and the second therapy element is carried on a second elongate flexible shaft. One of the first and second shafts is slidably received within a lumen of the other of the first and second shafts—so that the second therapy element may be advanced within the body relative to the first therapy element. A stimulator is configured to energize the first therapy element within the first blood vessel to deliver therapy to a first nerve fiber disposed external to the superior vena cava and to energize the second therapy element within the pulmonary artery to deliver sympathetic therapy to a second nerve fiber disposed external to the pulmonary artery.

Abstract: A satiation device is described which includes a sheath or liner extending from the proximal or middle stomach to the distal antrum. Food ingested by the patient passes through the sheath or liner, thereby minimizing contact between the ingested food and the stomach. It is believed that over time, reduced contact between food and the stomach will result in decreased Ghrelin production by the patient and a consequent decrease in appetite. In some embodiments, the satiation device may also include a proximal pouch and/or a distal bypass tube.