Apparatus and methods are described herein for use in the delivery and deployment of a prosthetic mitral valve into a heart. In some embodiments, an apparatus includes a catheter assembly, a valve holding tube and a handle assembly. The valve holding tube is releasably couplable to a proximal end portion of the catheter assembly and to a distal end portion of the handle assembly. The handle assembly includes a housing and a delivery rod. The delivery rod is configured to be actuated to move distally relative to the housing to move a prosthetic heart valve disposed within the valve holding tube out of the valve holding tube and distally within a lumen of the elongate sheath of the catheter assembly. The catheter assembly is configured to be actuated to move proximally relative to the housing such that the prosthetic valve is disposed outside of the lumen of the elongate sheath.

Features for a restraint, such as a cap, are described. The restraint secures a cardiac device in a collapsed, delivery configuration for transcatheter delivery to a heart. The restraint may have a tubular sidewall extending from a proximal end to a distal end, a proximal opening defined by the sidewall at the proximal end and a channel defined by the sidewall and extending distally from the proximal opening. The restraint is configured to receive the implant in the collapsed configuration through the proximal opening to radially restrain the implant within the channel. The restraint eliminates the need for a surrounding sheath, reducing the delivery profile and size of the overall delivery system, among other advantages. The restraint may have an atraumatic leading edge to reduce the risk of injury to the patient.

Various embodiments of an implant delivery systems including at least one removable actuator to reshape a valve annulus are described. The systems may use the removable actuator to customize annular reshaping at a treatment site and withdraw the actuator from the treatment site following custom reshaping to provide a low profile annuloplasty implant.

A prosthetic heart valve system may include a prosthetic heart valve, a tether having a first end configured to connect to the prosthetic heart valve and a second end, and a collapsible and expandable anchor. The anchor includes a center rim configured to couple to the second end of the tether. The anchor further includes a plurality of struts extending radially outward from the center rim forming an inner dome that is concave toward a heart when the anchor is in a resting configuration implanted on an apex of the heart. The anchor further includes a plurality of wings extending radially outward from the struts.

Described herein are devices for approximating targeted tissue by intertwining two or more sutures together. The sutures are attached to the targeted tissue and routed to a twister device. The twister device secures end portions of the sutures and twists them to intertwine the sutures. Controlling the number of twists provides control over the forces applied to the targeted tissue. In conjunction with visualization feedback, real-time adjustments can be made to achieved targeted results, such as elimination of mitral regurgitation when the disclosed methods and apparatus are applied to mitral valve repair.

A prosthetic cardiac valve assembly and method of implanting the same is disclosed. In certain disclosed embodiments, the prosthetic valve assembly is an annuloplasty ring with an attached artificial valve. The prosthetic valve assembly can be secured to native heart tissue by suturing or other suitable method of the annuloplasty ring to the native heart tissue. The prosthetic valve leaflets of the prosthetic valve can also be anchored to the native heart tissue to prevent prolapse. In certain embodiments, the prosthetic valve leaflets are anchored to the native papillary muscles. In still other embodiments, the prosthetic valve assembly contains exactly the number of prosthetic valve leaflets as are in the native valve that the prosthetic valve assembly is configured to replace. With the prosthetic valve assembly properly positioned, it will replace the function of the native valve.

In some examples, the disclosure describes an annuloplasty device that comprises a tube-like structure configured to extend around at least part of a circumference of an annulus of a cardiac or vascular valve of a patient, and at least one anchor configured to anchor the tube-like structure to the annulus. The tube-like structure is configured to decrease a distance between valve leaflets that extend from the annulus.

Heart tissue electrical activity mapping used to guide the placement of devices to intervene in (treat) structural heart disease. In some embodiments, the intervention comprises placement of an implantable device, and/or positioning of a therapeutic device used to remove and/or remodel tissue. In some embodiments, electrical activity mapping is performed along with spatial mapping of a body cavity. In some embodiments, the intervention device position is compared to the measured positions of anatomical structures critical to heart electrical function to assess and/or prevent complications due to the device damaging heart electrical function.

A transluminal sheath is advanced transseptally into a left atrium of the subject. A distal end of a surrounding-sheath, having an anchor disposed therein, is advanced via a distal end of the transluminal sheath, into a left ventricle of the subject via a commissure of the mitral valve. While the distal end of the surrounding-sheath is in the left ventricle, the surrounding-sheath is pulled proximally with respect to the anchor to expose the anchor. While the distal end of the surrounding-sheath is in the left ventricle, mitral valve tissue that is within the left ventricle is encircled by helically wrapping the anchor around the mitral valve tissue. Subsequently, the surrounding-sheath is extracted from the heart. Other embodiments are also described.

An implantable device delivered and deployed with a visualization and/or imaging system. An imaging element is positioned on a distal end of a flexible elongate member of the visualization/imaging system. The distal end with the imaging element is positioned adjacent the implant and/or the implant site, and moved relative to the longitudinal axis of the flexible elongate member to adjust the viewing field of the imaging device.