A heart valve replacement is provided including a tubular body portion having a proximal end, a distal end and a central portion arranged between said proximal and distal ends, defining a longitudinal direction of the valve replacement and having an inner wall region; a valve having at least one leaflet attached to the inner wall region of the central portion, each one of said leaflets being movable between a closing position and an opening position of the valve, wherein the tubular body portion is fabricated from a combination of a biostable polymer and a biodegradable biomaterial adapted to allow in-growth of tissue of the host and to increase its size concomitantly with surrounding organ structures of a host, and wherein the valve is fabricated of a biostable polymer connected to the biostable polymer of the tubular body portion.

A diametric adjustment mechanism for an implantable medical device including a track defining a series of diametric setpoints, including a first diametric setpoint and a second diametric setpoint, a rider engaged with the track such that the rider is selectively movable along the track from the first diametric setpoint to the second diametric setpoint and from the second diametric setpoint to the first diametric setpoint, and a biasing element biasing the rider toward the first diametric setpoint when the rider is at the second diametric setpoint.

A prosthetic heart valve includes a stent body and prosthetic leaflets. The stent body extends from an inflow end to an outflow end and includes an annulus section defining a first row of cells extending in a circumferential direction, the stent body being expandable from a delivery condition having a first diameter to a deployed condition having a second diameter larger than the first diameter. The prosthetic leaflets are mounted to the stent body allow flow in an antegrade direction but substantially block flow in a retrograde direction. The first row of cells is circumferentially continuous in the delivery condition and in the deployed condition, and the stent body is further expandable from the deployed condition to an open condition in which the first row of cells is circumferentially discontinuous.

A growth stent and valve and methods for making and using the same. The growth stent and valve may be delivered to treat early stage congenital lesions, while expanding to adult vessel diameters. In selected embodiments, the growth stent and valve can comprise a frame and may have a covering on some portion to prevent blood flow through a wall of the frame. The growth stent and valve advantageously can maintain radial strength across an entire range of diameters necessary to treat a narrowed lesion from birth and childhood through adulthood as the vessels grow over the lifetime of a patient.

Some embodiments are directed to a transcatheter and serially-expandable artificial heart valve, e.g., to be minimally-invasively implanted into a pediatric patient during a first procedure, and then expanded during a second procedure to accommodate for the pediatric patient's growth. Some embodiments include an expandable frame having a compressed, delivery configuration, and an expanded, deployed configuration, in which the valve is implantable within the patient. The valve can have a first working condition when the frame is expanded to a first diameter and a second working condition when the frame is expanded to a second diameter greater than the first diameter. The valve can include a plurality of leaflets configured to accommodate the expansion of the frame and growth of the patient.

An implantable, autonomously growing medical device is disclosed. The device may have an outer, braided outer element that holds an inner core. Degradation and/or softening of the inner core permits the outer element to elongate, allowing the device to grow with surrounding tissue. The growth profile of the medical device can be controlled by altering the shape/material/cure conditions of the inner core, as well as the geometry of the out element.

Systems and methods for the manufacture of an hourglass shaped stent-graft assembly having an hourglass shaped stent, graft layers, and an assembly mandrel having an hourglass shaped mandrel portion. Hourglass shaped stent may have superelastic and self-expanding properties. Hourglass shaped stent may be encapsulated using hourglass shaped mandrel assembly coupled to a dilation mandrel used for depositing graft layers upon hourglass shaped mandrel assembly. Hourglass shaped mandrel assembly may have removably coupled conical portions. The stent-graft assembly may be compressed and heated to form a monolithic layer of biocompatible material. Encapsulated hourglass shaped stents may be used to treat subjects suffering from heart failure by implanting the encapsulated stent securely in the atrial septum to allow blood flow from the left atrium to the right atrium when blood pressure in the left atrium exceeds that on the right atrium. The encapsulated stents may also be used to treat pulmonary hypertension.

The devices and methods of this disclosure relate to a heart valve prosthesis that is configured to be implanted within a native heart valve having a smaller perimeter annuli with a generally elliptical shape.

A growth stent and valve and methods for making and using the same. The growth stent and valve may be delivered to treat early stage congenital lesions, while expanding to adult vessel diameters. In selected embodiments, the growth stent and valve can comprise a frame and may have a covering on some portion to prevent blood flow through a wall of the frame. The growth stent and valve advantageously can maintain radial strength across an entire range of diameters necessary to treat a narrowed lesion from birth and childhood through adulthood as the vessels grow over the lifetime of a patient.

Some embodiments are directed to methods for serially expanding an artificial heart valve within a pediatric patient. For example, the artificial heart valve can be implanted into the pediatric patient during a first procedure, and then expanded during a second procedure to accommodate for the pediatric patient's growth. Some embodiments include introducing an expander into the implanted valve when the frame is expanded to a first working diameter, and then actuating the expander to expand the frame to a second working diameter greater than the first working diameter, to accommodate for the pediatric patient's growth.