Abstract: A delivery system for delivering a spiral anchor to a diseased native valve of a heart includes an anchor control catheter and an anchor guide extending from the anchor control catheter. The anchor guide includes a flexible configuration and a rigid configuration. The anchor guide in the rigid configuration includes a proximal section, a middle section, and a distal section. The proximal section includes a straight central axis and extends from the anchor control catheter, the middle section spirals axially and radially outwards from the central axis, and the distal section curves concentrically about the central axis in a plane that is perpendicular to the central axis.

Abstract: A delivery system for delivering a spiral anchor to a diseased native valve of a heart includes an anchor control catheter and an anchor guide extending from the anchor control catheter. The anchor guide includes a flexible configuration and a rigid configuration. The anchor guide in the rigid configuration includes a proximal section, a middle section, and a distal section. The proximal section includes a straight central axis and extends from the anchor control catheter, the middle section spirals axially and radially outwards from the central axis, and the distal section curves concentrically about the central axis in a plane that is perpendicular to the central axis.

Abstract: A delivery system for delivering a spiral anchor to a diseased native valve of a heart includes an anchor control catheter and an anchor guide extending from the anchor control catheter. The anchor guide includes a flexible configuration and a rigid configuration. The anchor guide in the rigid configuration includes a proximal section, a middle section, and a distal section. The proximal section includes a straight central axis and extends from the anchor control catheter, the middle section spirals axially and radially outwards from the central axis, and the distal section curves concentrically about the central axis in a plane that is perpendicular to the central axis.

Abstract: A device for treating a diseased native valve in a patient is provided, the device including a frame structure; a valve segment positioned radially within the frame structure, the valve segment comprising a plurality of leaflets, and a plurality of commissure attachment mechanisms coupling the leaflets to the frame structure, each commissure attachment mechanism extending radially inwards from an outflow end of the frame structure as to create a gap between an interior diameter of the outflow end and an outflow edge of the valve segment. Other embodiments and methods of use are also provided.

Abstract: A system for stabilizing and advancing a delivery system for direct access TAVI. The system includes an introducer support coupled to an introducer and a stable object, a cradle mechanism coupled to a handle of the delivery system and a stable object, and an adjustment mechanism coupled to the delivery system. Operation of the adjustment mechanism moves the delivery system distal of the handle in a distal or proximal direction. The introducer support may be coupled to a flexible position clamp. The cradle mechanism includes a cradle for the handle, a flexible arm coupled to the cradle, and a clamp coupled to the flexible arm and attached to the stable object. The stable object may be an operating table. The adjustment mechanism may be coupled to the delivery system adjacent the introducer. The adjustment mechanism may include a quick release mechanism.