Abstract: To percutaneously deliver a replacement tricuspid valve, a cable is percutaneously positioned with a first end extending out of the venous vasculature at the neck, and a second end extending out of a femoral access point. An eyehook device is positioned over the first end. A tricuspid valve delivery device (TVDD) is advanced over the second end, and then advanced through an IVC into a right atrium. The eyehook device is advanced into the right ventricle, drawing an intermediate portion of the cable into the right ventricle. Contact between the distal end of the eyehook device and the right ventricle is maintained while the TVDD is pushed from the femoral vein. The intermediate portion of cable applies a force to a distal nose of the TVDD that causes the distal nose to be steered into a tricuspid valve annulus as the TVDD is advanced.

Abstract: A system and method used to deliver a valve delivery system carrying a valve to a target valve annulus in the heart includes a cable percutaneously introduced into a vasculature of a patient and positioned to run from a femoral vein, transseptally through the heart, to a femoral artery. The valve delivery system device is passed over an end of the cable at the arterial side and is secured to the cable. The valve delivery system device is pushed in a distal direction while the venous end of the cable is pulled in the proximal direction, to advance the valve delivery system to the target valve annulus. A left ventricle redirector positionable on the cable from the venous end has a distal end actively steered during advancement and positioning of the valve delivery device, exerting forces that steer the distal nose of the valve delivery device as it moves towards the valve annulus.

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 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 an aortic valve therapeutic device, such as a delivery device for an aortic valve replacement, to an aortic valve site. The system 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 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 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 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 transeptal 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: 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 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 system and method used to deliver a valve delivery system carrying a valve to a target valve annulus in the heart includes a cable percutaneously introduced into a vasculature of a patient and positioned to run from a femoral vein, transseptally through the heart, to a femoral artery. The valve delivery system device is passed over an end of the cable at the arterial side and is secured to the cable. The valve delivery system device is pushed in a distal direction while the venous end of the cable is pulled in the proximal direction, to advance the valve delivery system to the target valve annulus. A left ventricle redirector positionable on the cable from the venous end has a distal end actively steered during advancement and positioning of the valve delivery device, exerting forces that steer the distal nose of the valve delivery device as it moves towards the valve annulus.

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 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: Endolumenal prostheses that readily and extensively convert from a delivery configuration to a deployed configuration are disclosed. Endolumenal prostheses may be fabricated from one or more shape memory polymers, a high modulus elastomer, a polymer that is both elastomeric and exhibits shape memory behavior, a hydrogel, or some combination thereof. Polymers used to fabricate the prostheses are selectively synthesized to exhibit desired characteristics such as crystallinity, strain fixity rate, strain recovery rate, elasticity, tensile strength, mechanical strength, cross-linking density, extent physical cross-linking, extent of covalent cross-linking, extent of interpenetrating networks, rate of erosion, heat of fusion, crystallization temperature, and acidity during erosion. The endolumenal prostheses convert to the deployed configuration following delivery to a treatment site, upon exposure to an initiator either present within the body naturally or introduced into the body.

Abstract: Methods of manufacturing polymeric intraluminal prostheses include annealing the polymeric material to selectively modify the crystallinity thereof. Annealing may be utilized to selectively modify various properties of the polymeric material of an intraluminal prosthesis, including: selectively increasing the modulus of the polymeric material; selectively increasing the hoop strength of the intraluminal prosthesis; selectively modifying the elution rate (increase or decrease) of a pharmacological agent subsequently disposed on or within the annealed polymeric material; selectively increasing/decreasing stress in the intraluminal prosthesis; and selectively modifying the polymeric material such that it erodes at a different rate.

Abstract: An intravascular electrode device for use in neuromodulation includes an anchor expandable from a radially compressed position to a radially expanded position. A lead extends from the anchor and has at least one conductor extending through it. A flex circuit is coupled to the anchor and comprises a flexible insulative substrate, a plurality of electrodes carried by the substrate, and a plurality of conductive traces carried by the substrate, each trace electrically coupled to an electrode and a conductor. Expansion of the anchor within a blood vessel biases the electrodes into contact with the surrounding blood vessel wall.

Abstract: A woven tubular endoprosthesis comprising means for locking the endoprosthesis in a deployed configuration is disclosed. The means for locking the endoprosthesis may comprise locking protrusions, notches, a chemical bond, a curable bond, or other mechanism. The woven fibers comprising the endoprosthesis may be hollow and comprise circumferentially oriented polymeric chains, and may be filled with a curable material. A method of treatment using an endoprosthesis according to the invention is also disclosed.