Abstract: Device for sustained controlled release of therapeutically active substance after implantation of the device alone or in combination with further implantable elements. The device has one layer of material having at least one therapeutically active substance, wherein the layer has a biodegradable matrix consisting of a mixture of 60-95% by dry weight of a first component (A) in the form of a copolymer of DL-lactide and glycolide (PLGA) with a molar ratio of DL-lactide to glycolide in the range of 40:60-60:40 and with a weight average molecular weight (MWw) in the range of 100,000-150,000 g/mol and 5-40% by dry weight of a second component (B) in the form of polyethylene glycol (PEG), the dry weights of component (A) and (B) complementing to 100% of the matrix. In this matrix the at least one therapeutically active substance is dissolved and/or suspended.

Abstract: Method for the preparation of an implantable device, wherein in a first step a non-degradable implantable device is at least partially covered or surrounded by at least one separate layer of material comprising a therapeutically active substance providing for sustained controlled release of said substance under physiological conditions, and wherein in a second step this is inserted into a wet or humid pouch through an opening thereof.

Abstract: A suture fastener is provided that is shaped so as to define a spiral portion and a radially-inward portion that is disposed radially inward from the spiral portion. The suture fastener, when in a resting state, has an unlocked conical helical configuration, in which the spiral portion is conically helical. The suture fastener is configured, upon being axially plastically deformed, when one or more portions of one or more sutures pass through respective portions of the suture fastener, to transition from the unlocked conical helical configuration to a locked planar spiral configuration, in which the spiral portion is planar spiral and the one or more sutures are fixedly coupled to the suture fastener. The radially-inward portion is neither helical nor spiral, both when the suture fastener is in the unlocked conical helical configuration and when the suture fastener is in the locked planar spiral configuration. Other embodiments are also described.

Abstract: An occlusion device is provided for occluding a left atrial appendage (LAA), including a compliant balloon defining a fluid-tight balloon chamber, and an actuating shaft, which is disposed at least partially within the balloon chamber for setting a distance between distal and proximal end portions of the balloon. A proximal LAA-orifice cover includes a frame and a covering fixed to the frame. An orifice-support stent is fixed to and extends distally from the proximal LAA-orifice cover, and is generally cylindrical when in a radially-expanded state. Other embodiments are also described.

Abstract: A surgical fastener instrument (30) includes an outer delivery tube (36); an inner delivery shaft (42), disposed at least partially in the outer delivery tube (36); and a handle (44) coupled to a proximal portion (46) of the outer delivery tube (36), and including a user control element (48) arranged to rotate the inner delivery shaft (42) with respect to the outer delivery tube (36). A suture fastener (32) is removably disposed in the outer delivery tube (36) in an unlocked conical helical configuration. Distal advancement of the inner delivery shaft (42), when one or more portions of one or more sutures (22) pass through respective portions of the suture fastener (32), transitions the suture fastener (32) from the unlocked configuration to a locked planar spiral configuration, in which the one or more sutures (22) are fixedly coupled to the suture fastener (32). Other embodiments are also described.

Abstract: An occlusion device (210) is provided for occluding a left atrial appendage (LAA), including a compliant balloon (230) defining a fluid-tight balloon chamber (232), and an actuating shaft (234), which is disposed at least partially within the balloon chamber (232) for setting a distance between distal and proximal end portions (236, 238) of the balloon (230). A proximal LAA-orifice cover (70) includes a frame (72) and a covering (74) fixed to the frame (72). An orifice-support stent (290) is fixed to and extends distally from the proximal LAA-orifice cover (70), and is generally cylindrical when in a radially-expanded state. Other embodiments are also described.

Abstract: A split-frame cardiac valve (20) is configured to assume a radially compressed configuration for transcatheter delivery and a radially expanded configuration for anchoring to a native cardiac valve annulus. The split-frame cardiac valve (20) includes circumferential frame segments (22) including respective stents (24) and prosthetic leaflets (30). When the split-frame cardiac valve (20) is in the radially expanded configuration: (a) each of the stents (24) surrounds less than 360 degrees of a central longitudinal axis (26) of the split-frame cardiac valve (20), (b) the circumferential frame segments (22) are slidingly coupled to one another so as to be axially slidable with respect to one another in and out of axial alignment with one another, and (c) when the circumferential frame segments (22) are axially aligned with one another, the stents (24) collectively define a tubular stent (32) that entirely surrounds the central longitudinal axis (26).

Abstract: An occlusion device (210) is provided for occluding a left atrial appendage (LAA), including a compliant balloon (230) defining a fluid-tight balloon chamber (232), and an actuating shaft (234), which is disposed at least partially within the balloon chamber (232) for setting a distance between distal and proximal end portions (236, 238) of the balloon (230). A proximal LAA-orifice cover (70) includes a frame (72) and a covering (74) fixed to the frame (72). An orifice-support stent (290) is fixed to and extends distally from the proximal LAA-orifice cover (70), and is generally cylindrical when in a radially-expanded state. Other embodiments are also described.

Abstract: An instrument for repairing an atrioventricular heart valve, mitral heart valve or tricuspid heart valve includes a first tube having a tube axis defining an axial direction. A leaflet grabbing structure is arranged at a distal part of the first tube and contiguous to the first tube. The leaflet grabbing structure has a main body and a jaw, the jaw being movable relative to the main body. The jaw has a first proximally facing abutment surface and the main body has a second, distally facing abutment surface. The instrument has a needle that is cannulated and forms an inner tube. The needle is releasable from the first tube and movable relative to the main body in axial directions. The leaflet grabbing structure clamps a leaflet of the heart valve between the first and second abutment surfaces, while the jaw allows the needle to extend therethrough.

Abstract: A surgical fastener instrument (30) includes an outer delivery tube (36); an inner delivery shaft (42), disposed at least partially in the outer delivery tube (36); and a handle (44) coupled to a proximal portion (46) of the outer delivery tube (36), and including a user control element (48) arranged to rotate the inner delivery shaft (42) with respect to the outer delivery tube (36). A suture fastener (32) is removably disposed in the outer delivery tube (36) in an unlocked conical helical configuration. Distal advancement of the inner delivery shaft (42), when one or more portions of one or more sutures (22) pass through respective portions of the suture fastener (32), transitions the suture fastener (32) from the unlocked configuration to a locked planar spiral configuration, in which the one or more sutures (22) are fixedly coupled to the suture fastener (32). Other embodiments are also described.