Replacement heart valve having improved preformed seal

A cardiac stent-valve for transcatheter delivery, the stent-valve being compressible to a compressed state for delivery, and expandable to an expanded state for implantation, the stent-valve comprising:

• a stent with an axial inflow end at a proximal end and an axial outflow end at a distal end,
• a plurality of leaflets arranged within the stent, and
• a sealing skirt for reduction or prevention of paravalvular leakage;
• wherein, in the expanded state, the sealing skirt comprises a tubular inner wall and a pocket which is positioned on the tubular inner wall and comprises an outer wall which extends radially outward from the tubular inner wall, the outer wall comprising:
• a first axial end connected to the tubular inner wall and disposed toward the axial inflow end, and
• a second axial end disposed toward the axial outflow end;
• wherein the pocket is configured to be distended radially outward in response to inflow of blood in the expanded state;
• and
• wherein, in the expanded state, the outer wall of the pocket comprises one or more pre-shaped bulges which extend radially outward from the outer wall of the pocket, wherein the one or more pre-shaped bulges are disposed more distal than the first axial end,
• wherein the outer wall comprises a portion that defines the one or more pre-shaped bulges and a portion that does not define a pre-shaped bulge.

A cardiac stent-valve for transcatheter delivery, the stent-valve being compressible to a compressed state for delivery, and expandable to an expanded state for implantation, the stent-valve comprising:

• a stent with an axial inflow end and an axial outflow end,
• a plurality of leaflets arranged within the stent, and
• a sealing skirt for reduction or prevention of paravalvular leakage;
• wherein, in the expanded state, the sealing skirt comprises a tubular inner wall and a pocket which is positioned on the tubular inner wall and comprises an outer wall which extends radially outward from the tubular inner wall, the outer wall comprising:
• a first axial end connected to the tubular inner wall and disposed towards the axial inflow end, and
• a second axial end disposed towards the axial outflow end;
• wherein the pocket is configured to be distended radially outward in response to inflow of blood in the expanded state;
• and
• wherein, in the expanded state, the outer wall of the pocket comprises two pre-shaped bulges which extend radially outward from the outer wall of the pocket, wherein the two pre-shaped bulges are distanced from the first axial end by a non-bulge portion of the outer wall, wherein the two pre-shaped bulges are distanced from the second axial end by a non-bulge portion of the outer wall,
• wherein the outer wall defines a first arc, and the two pre-shaped bulges form a second arc and a third arc, wherein the second arc is adjacent to the third arc, and the first arc, the second arc, and the third arc open in a similar direction.