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 The venous-side end of the flexible device is withdrawn out the venous vasculature superior to the heart, and a pVAD is secured to the flexible device.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: A steering catheter includes an elongate shaft with an actively steerable distal part. An internal pull wire and an external pullwire extend through the shaft. The shaft has a first position in which the elongate shaft is generally straight and the external pullwire extends along the exterior of the distal portion of the shaft, a second position in which the shaft is curved and in which the external pullwire extends along the exterior of the distal portion of the shaft, and a third position in which the shaft is curved and in which the external pullwire extends laterally between laterally adjacent portions of the distal portion of the shaft, wherein the external pull wire locks the shaft in the curved position.

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: 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 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: According to a system and method for percutaneously delivering a replacement tricuspid valve to a heart, a wire is percutaneously introduced into the venous vasculature. A distal end of the wire is passed into a right atrium, through a tricuspid valve ring, and into a right ventricle, within which it is anchored to tissue of the right ventricle. A tricuspid valve delivery device carrying a replacement tricuspid valve is positioned over the wire, and a director is positioned over the wire proximally adjacent to, and in contact with, the tricuspid valve delivery device. The director and delivery device are pushed over the wire into the right atrium while traction is applied traction to the wire that is fixed within the right ventricle. The director is actively articulated during advancement, to articulate the replacement tricuspid valve on the valve delivery device within a tricuspid valve ring of the heart.

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 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 passive proximal curve, a steerable distal curve, a generally straight segment extending between the curves, and a distal tip. The shaft in the distal loop section is steerable to cause it to curve 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 method for delivering a therapeutic device to a target aortic valve site includes transseptally positioning a cable to run between afemoral vein, through the heart via the right atrium, left atrium, mitral valve, aortic valve and into the aorta and arterial vasculature with the flexible cable having a first end extending outside the body from a venous vessel and a second end external to the patient at the femoral artery. The aortic valve therapeutic device is advanced over the cable from 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 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: 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.