A percutaneous device including a temporary valve attached to a sheath, the sheath having an inverting section for delivery and removal thereof from a blood vessel. The sheath is inverted for delivery, housing the valve between inverted layers thereof. To deploy said valve, the sheath is everted to position the temporary valve on an outer surface thereof. The temporary valve and sheath are reversibly movable between inverted and deployed configurations. Upon eversion, the temporary valve assumes a radially expanded canopy shape having an outer diameter selected to contact the vessel wall and allow blood flow in only one direction. The temporary valve may be removed by releasing one end of the valve from the sheath, flattening the temporary valve along the longitudinal axis of the sheath. Also provided is a temporary valve system comprising a dilator for inverting and everting the sheath, said dilator being removably connected to the sheath.

An annuloplasty ring for repair of mitral and tricuspid valves that can be shape adjusted once installed to fine-tune the shape and correct for small errors in the inherently imprecise sizing process. The ring has an adjustable 3D ring core of malleable metal that can be reshaped in real-time during the procedure before or after the patient is weaned off-pump by applying simple displacements to a cable and housing arrangement. The shape of the annuloplasty ring is adjusted incrementally in steps until an optimum level of regurgitation reduction is attained. Once the surgeon is satisfied with the result, the delivery system can be can easily detached from the implant and removed. The thickness of the core could be continuously variable to control how and where deformation occurs. The ring may also incorporate an expansion joint to enable a subsequent valve-in-ring procedure.

A method for treating a diseased native valve in a patient includes tracking a positioning tool in a first configuration and a valve delivery device over a tether into a heart where the tether is connected to a spiral anchor in the heart; activating the positioning tool from the first configuration to a second configuration that is stiffer than the first configuration; adjusting, with the positioning tool, a position of the spiral anchor relative to a valve positioned within the delivery device; and deploying a valve from the delivery device to an expanded position within the spiral anchor.

The present technology relates to adjustable interatrial shunts that are configured to shunt blood between the left atrium and the right atrium. In particular, the adjustable interatrial shunts can include a flow control element moveable through a plurality of discrete position, with each discrete position being associated with a particular shunt geometry, and with each particular shunt geometry being associated with a different fluid resistance and/or relative drainage resistance through the shunt for a given pressure differential between the left atrium and the right atrium. The flow control element can be selectively moveable between the plurality of discrete positions by operation of an actuation assembly. In some embodiments, the adjustable interatrial shunts include a ratchet mechanism that controls the movement of flow control element through the plurality of discrete positions, and can hold or lock the shunt in a desired position or configuration.

The disclosure relates to transcatheter stented prosthesis delivery devices including a handle assembly connected to a shaft assembly on which a stented prosthesis is loaded and compressively retained with a plurality of elongate tension members. The delivery devices include a cutting assembly that can sever the elongate tension members after the stented prosthesis is expanded at a target site so that the delivery device can be withdrawn from the patient. Certain embodiments position the cutting assembly at least within the shaft assembly and others position the cutting assembly over the shaft assembly. Various disclosed cutting assemblies are actuated with the handle assembly or the like, which draw the tension members across the blade or vice versa.

Apparatus and methods are described herein for use in the delivery of a prosthetic mitral valve. In some embodiments, an apparatus includes an epicardial pad configured to engage an outside surface of a heart to secure a prosthetic heart valve in position within the heart. The epicardial pad defines a lumen configured to receive therethrough a tether extending from the prosthetic valve. The epicardial pad is movable between a first configuration in which the epicardial pad has a first outer perimeter and is configured to be disposed within a lumen of a delivery sheath and a second configuration in which the epicardial pad has a second outer perimeter greater than the first outer perimeter. The epicardial pad can be disposed against the outside surface of the heart when in the second configuration to secure the prosthetic valve and tether in a desired position within the heart.

The present invention relates to an apparatus (100) for folding or unfolding at least one medical implant (300) by using at least one tension thread (11, 11′), wherein the apparatus (100) includes a shaft (1) including a reception area for receiving the implant (300), a tensioning device for altering a shape of the foldable and/or unfoldable implant (300) by the tension thread (11, 11′), and a clamping mechanism for clamping at least one section of at least one of the tension threads (11, 11′). The present invention further relates to a set and a method.

Disclosed in the present invention are a stent apparatus having a self-pleated skirt, a processing method therefor, a skirt pleating method, and a cardiac valve. The stent apparatus comprises a stent, and is further provided with a flexible skirt. The skirt comprises: an unfolded state, where the skirt extends axially and surrounds the periphery of the stent before release; and a stacked state, where the skirt is driven by deformation during release of the stent, and gathers and is stacked along an axial direction of the released stent to form an annular perivalvular leakage blocking part. The stent apparatus is further provided with a pull-wire which is merely threaded on the skirt, and the pull-wire may react to the radial deformation during the release of the stent to drive the skirt to enter the stacked state. According to the present invention, based on perivalvular leakage prevention technology, an interventional stent is fitted with the lining of the blood vessels, so that the stent will not easily be migrated and is more stable, the scope of the applicable population is expanded, additional surgical risks are lowered, and perivalvular leakage, thrombi and other complications are prevented. Better hemodynamic performance is provided, the coverage function of endothelial cells of the host is enhanced, the probability of occurrence of endocarditis is lowered, and the normal blood supply function of the heart and blood vessels is recovered.

A transcatheter prosthesis with radially compressed and expanded configurations. An elongate member encircling at least a portion of the prosthesis, and configured to provide a seal between the prosthesis and a native anatomy when the prosthesis is deployed in the radially expanded configuration. The elongate member may be a resilient elongate member having a radially contracted state, when in tension, to hold at least the portion of the prosthesis in the radially compressed configuration, and having a radially expanded state, when relaxed, to provide the seal between at least the portion of the prosthesis and a native anatomy when the prosthesis is deployed. A system for delivering the transcatheter prosthesis may include a delivery catheter having an elongate cinching member encircling at least a second portion of the prosthesis, wherein the elongate cinching member is configured to hold the second portion of the prosthesis in the radially compressed configuration.

A valve for endovascular heart valve repair that provides improved sealing of the valve against the native wall. The valve assembly has a sealing region at a distal end of the valve. The sealing region having a delivery position and a sealing position, wherein in the delivery position, the sealing region has a first length, and in the sealing position, the sealing region has a second length less than the first length and a thickness in the sealing position is greater in the sealing position than in the delivery position.