Abstract: Catheter assembly with a coaptation aid for repair of leaflets of a heart valve includes an elongate catheter shaft adapted to be positioned transvascularly proximate a heart valve and a lever coupled to the catheter shaft. The lever has a hinge to transition the lever between an elongate delivery configuration generally aligned longitudinally with the catheter shaft and a deployed configuration extending transversely from the catheter shaft. The lever also includes an atraumatic tip at a distal end thereof and adapted to contact a distal side of a native leaflet of the heart valve when the catheter shaft is positioned proximate the heart valve and the lever is in the deployed configuration, and an actuation assembly coupled to the lever to remotely transition the lever between the delivery configuration and the deployed configuration. Method for fixation of native leaflets of a heart valve using the catheter assembly also disclosed.

Abstract: Fixation system for engaging tissue of a patient including an implantable fixation device having a first arm and a second arm, a first proximal element, a second proximal element, and a coupling member. The system includes a delivery device having a catheter, a shaft extending through the at least one lumen of the catheter, a first proximal element actuator and a second proximal element actuator. The second end portions of the first proximal element actuator and second proximal element actuator can be coupled to at least one of the shaft and the coupling member.

Abstract: Fixation device for fixation of leaflets of a heart valve includes an elongate central member defining a longitudinal axis of the fixation device and first and second arms rotatable about at least one arm hinge point between an open position and a closed position. The fixation device further includes a first gripping element rotatable about a first gripping element axis of rotation to capture a first leaflet of a heart valve between the first gripping element and the first arm. The fixation device further includes a second gripping element rotatable about a second gripping element axis of rotation to capture a second leaflet of a heart valve between the second gripping element and the second arm. At least one of the first gripping element axis of rotation and the second gripping element axis of rotation is variably offset from the arm hinge point by an axis offset distance defined along the longitudinal axis.

Abstract: Delivery system for fixation device, including guide catheter with proximal end portion having proximal end port, distal end portion having distal end port, and inner surface defining inner lumen extending in fluid communication between proximal end port and distal end port. Delivery catheter extending through the inner lumen to define annular space between outer surface of the delivery catheter and inner surface of the guide catheter. A pressure sensor proximate the proximal end portion in fluid communication with the annual space to monitor fluid pressure. The distal end portion of the guide catheter includes flow passages in fluid communication between an exterior of the distal end portion and the annular space.

Abstract: The invention provides medical devices, systems and methods for tissue approximation and repair and in particular to reduce mitral regurgitation by means of improved coaptation. The devices, systems and methods of the invention will find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions, including the cardiovascular system, heart, other organs, vessels, and tissues. The invention is particularly useful in those procedures requiring minimally-invasive or endovascular access to remote tissue locations, where the instruments utilized must negotiate long, narrow, and tortuous pathways to the treatment site.

Abstract: Fixation device for fixation of leaflets of a heart valve includes a central assembly and at least one arm moveably coupled to the central assembly. The at least one arm includes a body portion having a first end and a second end and a longitudinal axis defined therebetween, the second end being moveable between a closed position and an open position, the body portion having opposing body lateral sides, each body lateral side extending between the first end and the second end, the body portion having a body portion width defined between the opposing body lateral sides. The at least one arm further includes first and second nondeformable wing extensions, each wing extension extending laterally from a respective lateral side, each wing extension having a lateral outer edge, wherein a maximum arm width is defined between the outer lateral edge of the first wing extension and the outer lateral edge of the second wing extension.

Abstract: Fixation system for fixation of leaflets of a heart valve including an implantable fixation device having a first arm and a second arm, a first proximal element moveable relative to the first arm between a first position and a second position, and a second proximal element moveable relative to the second arm between a first position and a second position. The fixation system includes a delivery device having a catheter, a first proximal element line and a second proximal element line, and a handle having a first and second proximal element line handles coupled to the first proximal element line and the second proximal element line, respectively. The handle can include an interlock moveable between an unlocked position and a locked position.

Abstract: A scaffold includes a radiopaque marker connected to a strut. The marker is retained within the strut by a head at one or both ends. The marker is attached to the strut by a process that includes forming a rivet from a radiopaque bead and attaching the rivet to the marker including deforming the rivet to enhance resistance to dislodgement during crimping or balloon expansion. The strut has a thickness of about 100 microns.

Abstract: A jointed system for delivering a medical device to a target location within a human anatomy, comprising: a first segment that is a hollow cylinder, wherein a first flange and a second flange are attached to the distal end and extend distally away from the first segment; a second segment that is a hollow cylinder and has a proximal end and a distal end, wherein a third flange and a fourth flange are attached to the proximal end and extend proximally away from the second segment; a connector element having four cylindrical lugs extending radially away from a central point, wherein each lug passes, respectively, through a circular hole, and further wherein the connector element defines at least two separate openings extending in a direction from the distal end of the first segment to the proximal end of the second segment.

Abstract: A scaffold includes a radiopaque marker connected to a strut. The marker is retained within the strut by a head at one or both ends. The marker is attached to the strut by a process that includes forming a rivet from a radiopaque bead and attaching the rivet to the marker including deforming the rivet to enhance resistance to dislodgement during crimping or balloon expansion. The strut has a thickness of about 100 microns.

Abstract: A device for connecting together two opposing leaflets of a valve in a patient's heart, comprising: a first clip having a generally U-shape, comprising a first prong and a second prong, and a first bridge connecting the first prong to the second prong; a second clip having a generally U-shape, comprising a third prong and a fourth prong, and a second bridge connecting the third prong to the fourth prong; a third clip having a generally U-shape, comprising a fifth prong and a sixth prong, and a third bridge connecting the fifth prong to the sixth prong, wherein the third prong has a first elongate axis and the fifth prong has a second elongate axis and the third prong and the fifth prong are positioned to extend adjacent to and parallel with the first prong, and are configured to rotate about the first elongate axis and the fifth elongate axis respectively.

Abstract: A device for connecting together two opposing leaflets of a valve in a patient's heart, comprising: a first clip having a generally U-shape, comprising a first prong and a second prong, and a first bridge connecting the first prong to the second prong; a second clip having a generally U-shape, comprising a third prong and a fourth prong, and a second bridge connecting the third prong to the fourth prong; a third clip having a generally U-shape, comprising a fifth prong and a sixth prong, and a third bridge connecting the fifth prong to the sixth prong, wherein the third prong has a first elongate axis and the fifth prong has a second elongate axis and the third prong and the fifth prong are positioned to extend adjacent to and parallel with the first prong, and are configured to rotate about the first elongate axis and the fifth elongate axis respectively.

Abstract: A thin-walled scaffold has a network of rings interconnected by links. A link includes holding a radiopaque marker connects adjacent rings. The link and/or a nearby ring is modified to compensate for the thin walls when the scaffold is crimped to a balloon.

Abstract: A thin-walled scaffold includes a radiopaque marker connected to a link. In a first example, the marker is retained on the strut by a head at one or both ends by swaging. In a second example of a thin-walled scaffold the link is modified to avoid interference during crimping. In a third example a distal end of the thin-walled scaffold is modified to improve deliverability of the thin-walled scaffold. These features are combined in a fourth example.

Abstract: Fixation device for engaging tissue including a pair of fixation elements, each fixation element has a first end and a second end opposite the first end, the first ends are moveable between a closed position and an open position. The fixation device further includes a pair of gripping elements. Each gripping element is moveable with a respective fixation element and disposed in opposition to at least a portion of the respective fixation element to capture tissue therebetween. The fixation device further includes a central portion operatively connected to each gripping element at a respective central portion-gripping element interface. The central portion has at least one distal end and a width “W1” proximate the distal end. Each of the gripping elements has a free end opposite its respective central portion-gripping element interface and a length “L1” defined between the respective central portion-gripping element interface and the free end.

Abstract: A stent or scaffold has a tapered end or ends. The scaffold is made using an additive manufacturing technique such as stereolithography (SLA). The scaffold may take the shape of a frustum, or a scaffold having one or both of its ends flared. The scaffold has varying mechanical properties over its length, such as a varying ring stiffness, porosity or elasticity modulus. In one embodiment the strut and link widths change linearly from the distal to proximal ends.

Abstract: The invention provides medical devices, systems and methods for tissue approximation and repair and in particular to reduce mitral regurgitation by means of improved coaptation. The devices, systems and methods of the invention will find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions, including the cardiovascular system, heart, other organs, vessels, and tissues. The invention is particularly useful in those procedures requiring minimally-invasive or endovascular access to remote tissue locations, where the instruments utilized must negotiate long, narrow, and tortuous pathways to the treatment site.

Abstract: A jointed system for delivering a medical device to a target location within a human anatomy, comprising: a first segment that is a hollow cylinder, wherein a first flange and a second flange are attached to the distal end and extend distally away from the first segment; a second segment that is a hollow cylinder and has a proximal end and a distal end, wherein a third flange and a fourth flange are attached to the proximal end and extend proximally away from the second segment; a connector element having four cylindrical lugs extending radially away from a central point, wherein each lug passes, respectively, through a circular hole, and further wherein the connector element defines at least two separate openings extending in a direction from the distal end of the first segment to the proximal end of the second segment.

Abstract: A thin-walled scaffold includes a radiopaque marker connected to a link. In a first example, the marker is retained on the strut by a head at one or both ends by swaging. In a second example of a thin-walled scaffold the link is modified to avoid interference during crimping. In a third example a distal end of the thin-walled scaffold is modified to improve deliverability of the thin-walled scaffold. These features are combined in a fourth example.

Abstract: A method of stimulating a renal nerve in a human patient comprising, selecting a span of renal artery in the patient for implantation of a self-expanding stent, the artery having a first internal diameter, an artery wall, and being surrounded by peri-adventitial space through which at least one renal nerve extends; measuring the first internal diameter; selecting a self-expanding stent configured to be capable of expanding to have a second diameter that, in an expanded condition once implanted within the artery, is between 2 mm and 4 mm larger than the first diameter; implanting the stent in the span of the renal artery, whereby the stent eventually expands to the second diameter and thereby passes through the artery wall to become embedded in peri-advential space; and at least partially blocking the renal nerve or modulating a function of the nerve.