Abstract: A prosthetic aortic valve device, delivery system, interventional system, and related method are disclosed. The device includes an inner frame having relative compressed and expanded configurations; leaflets connected to the inner frame and cooperating with each other to control opening and closing of the blood flow passage; and a positioning mechanism arranged in a circumferential direction of the inner frame, the positioning mechanism including a fixed end connected to the inner frame and a free end extending towards the inflow end, the positioning mechanism being configured to be switchable among a loaded configuration, a transition configuration, and a released configuration.

Abstract: The present invention provides a prosthetic heart valve device that has a frame, and a leaflet assembly having a plurality of leaflets that are secured to the frame. The frame is defined by an annular body and has three spaced-apart commissure regions, each commissure region having a commissure post extending from a proximal outflow end of the frame. A first clipping arm and a second clipping arm extend from opposite sides of each commissure post, each clipping arm extending from each commissure post at an obtuse angle with respect to each commissure post. Each clipping arm has a free end with a tip provided at the free end. The body has a first diameter at a location where the tips of the clipping arms are located, and the tips of the clipping arms extend away from define a second diameter, with the second diameter being greater than or equal to the first diameter.

Abstract: A prosthetic implant delivery assembly includes a prosthetic implant and a catheter. The prosthetic implant includes a plurality of apices with apertures. Each apex of the plurality of apices is circumferentially-spaced apart relative to an adjacent apex. The catheter includes a plurality of arms and a plurality of locking elements. Each of the arms includes an opening configured to receive a respective apex of the prosthetic implant. Each of the locking elements is configured to extend through the aperture of a respective apex of the prosthetic implant. A length of at least one of the locking elements is different than a length of another locking element such that when the prosthetic implant is coupled to the catheter by the locking elements, a longitudinal axis of the prosthetic implant can be held at a tilted position relative to a longitudinal axis of the catheter.

Abstract: The present invention provides a prosthetic heart valve device that has a frame, and a leaflet assembly having a plurality of leaflets that are secured to the frame. The frame is defined by an annular body and has three spaced-apart commissure regions, each commissure region having a commissure post extending from a proximal outflow end of the frame. A first clipping arm and a second clipping arm extend from opposite sides of each commissure post, each clipping arm extending from each commissure post at an obtuse angle with respect to each commissure post. Each clipping arm has a free end with a tip provided at the free end. The body has a first diameter at a location where the tips of the clipping arms are located, and the tips of the clipping arms extend away from define a second diameter, with the second diameter being greater than or equal to the first diameter.

Abstract: A method of implanting a prosthetic heart valve includes advancing a distal end portion of a catheter shaft through a patient's vasculature. The distal end portion of the catheter shaft includes an expansion device. A prosthetic heart valve is mounted on the expansion device with the expansion device and the prosthetic heart valve in a compressed configuration. The method further includes positioning the distal end portion of the catheter shaft and the prosthetic heart valve to an implantation location and expanding the prosthetic heart valve and the expansion device to an expanded configuration. The expansion device includes a main body and a plurality of projections extending radially from the main body. The projections are spaced apart relative to each such that there are grooves extending between adjacent projections providing perfusion passageways between the expansion device and the prosthetic heart valve when the expansion device is in the expanded configuration.

Abstract: A method of implanting a prosthetic heart valve includes advancing a distal end portion of a catheter shaft through a patient's vasculature. The distal end portion of the catheter shaft includes an expansion device. A prosthetic heart valve is mounted on the expansion device with the expansion device and the prosthetic heart valve in a compressed configuration. The method further includes positioning the distal end portion of the catheter shaft and the prosthetic heart valve to an implantation location, and expanding the prosthetic heart valve and the expansion device from the compressed configuration to an expanded configuration. The expansion device includes an inner expandable member and a plurality of outer expandable members. The outer expandable members are distributed such that there are gaps providing perfusion passageways between the expansion device and the prosthetic heart valve when the expansion device is in the expanded configuration.

Abstract: A prosthetic mitral valve system that comprises a valve dock and a prosthetic mitral valve is disclosed. The valve dock comprises clamp jaws that sandwich the native mitral valve leaflets and the native mitral valve annulus between them anchoring the prosthetic mitral valve system at or adjacent to the native mitral valve annulus. Further, a prosthetic mitral valve comprising atrial and ventricular clamp jaws and which can be implanted at or adjacent to the native mitral valve annulus without a valve dock system is disclosed. Novel methods and systems for treating mitral valve disease or malfunction by percutaneous replacement of the mitral valve (or the tricuspid valve) are disclosed.

Abstract: The present invention provides a prosthetic heart valve device that has a frame, and a leaflet assembly having a plurality of leaflets that are secured to the frame. The frame is defined by an annular body and has three spaced-apart commissure regions, each commissure region having a commissure post extending from a proximal outflow end of the frame. A first clipping arm and a second clipping arm extend from opposite sides of each commissure post, each clipping arm extending from each commissure post at an obtuse angle with respect to each commissure post. Each clipping arm has a free end with a tip provided at the free end. The body has a first diameter at a location where the tips of the clipping arms are located, and the tips of the clipping arms extend away from define a second diameter, with the second diameter being greater than or equal to the first diameter.

Abstract: A replacement heart valve system and a method of implanting a replacement heart valve in a patient. The replacement heart valve system includes a radially self-expandable tubular body and a valve including a plurality of leaflets coupled to the tubular body. The tubular body includes interconnected struts defining circumferential rows of cells, and has an outflow end and an inflow end that flares radially outward so as to have a larger outer diameter than that of the outflow end. A first row of proximal-most cells formed at the inflow end includes circumferentially adjacent cells that are disconnected from each other so as to be spaced from each other in the circumferential direction. A method of implanting the replacement heart valve includes delivering from a delivery catheter the tubular body, and expanding the tubular body such that the proximal-most cells are disposed against the native heart valve annulus.

Abstract: A replacement heart valve system and a method of implanting a replacement heart valve in a patient. The replacement heart valve system includes a radially self-expandable tubular body and a valve including a plurality of leaflets coupled to the tubular body. The tubular body includes interconnected struts defining circumferential rows of cells, and has an outflow end and an inflow end that flares radially outward so as to have a larger outer diameter than that of the outflow end. A first row of proximal-most cells formed at the inflow end includes circumferentially adjacent cells that are disconnected from each other so as to be spaced from each other in the circumferential direction. A method of implanting the replacement heart valve includes delivering from a delivery catheter the tubular body, and expanding the tubular body such that the proximal-most cells are disposed against the native heart valve annulus.

Abstract: One method of implanting a prosthetic valve includes advancing the valve into a patient with a delivery apparatus. The valve includes apices circumferentially-spaced apart relative to each other. At least some of the apices include first apertures. The delivery apparatus includes release arms and a sheath. The release arms include second apertures for receiving the apices. At least one of the second apertures of the release arms has a different length than another one of the second apertures. The method also includes positioning the valve at a location, retracting a sheath of the delivery apparatus relative to the valve, allowing the valve to self-expand from a radially compressed state to a radially expanded state, and while the valve is coupled to the delivery apparatus, pivoting the valve relative about the release arms such that an axis of the valve is tilted relative to an axis of the delivery apparatus.

Abstract: A method of implanting a prosthetic heart valve includes advancing a distal end portion of a catheter shaft through a patient's vasculature. The distal end portion of the catheter shaft includes an expansion device. A prosthetic heart valve is mounted on the expansion device with the expansion device and the prosthetic heart valve in a compressed configuration. The method further includes positioning the distal end portion of the catheter shaft and the prosthetic heart valve to an implantation location, and expanding the prosthetic heart valve and the expansion device from the compressed configuration to an expanded configuration. The expansion device includes an inner expandable member and a plurality of outer expandable members. The outer expandable members are distributed such that there are gaps providing perfusion passageways between the expansion device and the prosthetic heart valve when the expansion device is in the expanded configuration.

Abstract: One method of implanting a prosthetic valve includes advancing the valve into a patient with a delivery apparatus. The valve includes apices circumferentially-spaced apart relative to each other. At least some of the apices include first apertures. The delivery apparatus includes release arms and a sheath. The release arms include second apertures for receiving the apices. At least one of the second apertures of the release arms has a different length than another one of the second apertures. The method also includes positioning the valve at a location, retracting a sheath of the delivery apparatus relative to the valve, allowing the valve to self-expand from a radially compressed state to a radially expanded state, and while the valve is coupled to the delivery apparatus, pivoting the valve relative about the release arms such that an axis of the valve is tilted relative to an axis of the delivery apparatus.

Abstract: A delivery system for stabilizing a catheter shaft across an aortic arch can include one or more stabilizing members configured to fix or stabilize the position of the catheter relative to the aortic arch of a patient.

Abstract: A prosthetic implant delivery assembly can include a prosthetic implant and an elongate catheter. The prosthetic implant can include an expandable stent portion having a longitudinal axis extending from a first end portion of the stent to a second end portion of the stent. The catheter can include a longitudinal axis extending from a proximal end portion of the catheter to a distal end portion of the catheter and a plurality of arms extending axially from the distal end of the catheter. The first end portion of the stent can be releasably and pivotably coupled to at least one the arms of the catheter such that the stent can pivot about the at least one of the arms so that the longitudinal axis of the stent is tilted relative to the longitudinal axis of the catheter.

Abstract: A prosthetic implant delivery assembly can include a prosthetic implant and an elongate catheter. The prosthetic implant can include an expandable stent portion having a longitudinal axis extending from a first end portion of the stent to a second end portion of the stent. The catheter can include a longitudinal axis extending from a proximal end portion of the catheter to a distal end portion of the catheter and a plurality of arms extending axially from the distal end of the catheter. The first end portion of the stent can be releasably and pivotably coupled to at least one the arms of the catheter such that the stent can pivot about the at least one of the arms so that the longitudinal axis of the stent is tilted relative to the longitudinal axis of the catheter.

Abstract: Method for delivering an expandable member to a treatment location includes an elongate shaft and an expandable member coupled to a distal end of the elongate shaft. Embodiments of the expandable member are moveable between a collapsed configuration and an expanded configuration, and have an inner expandable member and a plurality of outer expandable members that at least partially surround the inner expandable member, and are suitable for delivering prosthetic heart valves and performing vavuloplasties.

Abstract: A delivery system for stabilizing a catheter shaft across an aortic arch can include one or more stabilizing members configured to fix or stabilize the position of the catheter relative to the aortic arch of a patient.

Abstract: Methods and apparatus for off-axis visualization are described herein. An endoluminal tissue manipulation assembly is disclosed which provides for a stable endoluminal platform and which also provides for effective triangulation of tools. Such an apparatus may comprise an optionally shape-lockable elongate body defining a longitudinal axis and adapted for endoluminal advancement in a patient body, at least one articulatable visualization lumen disposed near or at a distal region of the elongate body, the at least one articulating visualization lumen being adapted to articulate off-axis relative to a longitudinal axis of the elongate body, and at least one articulatable tool arm member disposed near or at the distal region of the elongate body, the at least one articulatable tool arm member being adapted to articulate off-axis and manipulate a tissue region of interest.

Abstract: Method for delivering an expandable member to a treatment location includes an elongate shaft and an expandable member coupled to a distal end of the elongate shaft. Embodiments of the expandable member are moveable between a collapsed configuration and an expanded configuration, and have an inner expandable member and a plurality of outer expandable members that at least partially surround the inner expandable member, and are suitable for delivering prosthetic heart valves and performing vavuloplasties.