Abstract: Some embodiments are directed to a stent graft comprising a first stent graft having a first stent, a first inner graft supported by the first stent, a second inner graft supported by the first stent, and an outer graft. The second inner graft can be spaced apart from the first inner graft along the length of the first stent so that a portion of the first stent is not covered by either the first inner graft or the second inner graft. A first portion and a second portion of the outer graft can be attached to the first stent, the outer graft being unsupported by the stent between the first and second portions so as to form a fillable space between the outer graft, the first inner graft, and the second inner graft. Some embodiments further comprise a second stent graft deployable within the inside of the first stent graft to sealingly cover the uncovered portion of the first stent.

Abstract: Some embodiments are directed to a deployment system for deploying a stent graft within a passageway, comprising a delivery catheter having an outer sheath, a proximal end, and a distal end, a stent having a first end and a second end, a graft having a first end and a second end, and at least one connecting element extending from the second end of the stent to the first end of the graft so as to connect the stent to the graft. In some embodiments, the stent can be supported within the outer sheath at a first axial position in a collapsed state, and the graft can be supported within the outer sheath at a second axial position different than the first axial position in a collapsed state, such that the stent does not overlap or substantially overlap the graft in the collapsed state within the deployment system.

Abstract: Expandable prosthetic heart valves for minimally invasive valve replacement are disclosed. In one preferred embodiment, an expandable prosthetic heart valve includes a support stent comprising an expandable tubular base along an inflow end and three upstanding commissure posts along an outflow end. The three commissure posts are spaced at 120 degree intervals with gaps therebetween. The prosthetic heart valve further includes a tubular flexible member having a prosthetic section and a fabric section. The prosthetic section is connected to the three commissure posts and defines three leaflets, preferably formed of pericardial tissue. The fabric section is sutured to the expandable tubular base. The tubular base may be formed with a shape memory material and is sized for deployment with an annulus of a native aortic valve. After deployment, the three commissure posts support the leaflets above the tubular base for replacing the function of the native aortic valve.

Abstract: A method of data quality management including selecting a task group wherein the task group comprises at least one data validation sub-task. In one embodiment, the method may also include arranging at least a portion of a master data into a validation group, wherein the validation group is associated with the task group. In various embodiments, the method may include, for each data validation sub-task, determining a sub-task type, validating the validation group as directed by the data validation sub-task, and calculating a set of key performance indicators (KPIs) associated with the data validation sub-task.

Abstract: Some embodiments are directed to a catheter system comprising an introducer having a main body, an introducer sheath projecting from the main body, and a first seal supported within the introducer and a catheter having a main body, an outer sheath projecting from the main body, a second seal supported within the catheter, and an inner core configured to be advanced axially through the main body, the second seal, and the outer sheath. The introducer can be configured to be selectively engageable with the catheter so that the catheter can be selectively and removably linked with the introducer in the axial direction. The catheter system can also be configured such that, when the introducer and the catheter are linked, the catheter can be rotatable relative to the introducer. The introducer can be configured to radially restrain an endoluminal prosthesis.

Abstract: An elongate body including a proximal and distal anchor, and a bridge between the proximal and distal anchors. The bridge has an elongated state, having first axial length, and a shortened state, having a second axial length, wherein the second axial length is shorter than the first axial length. A resorbable thread may be woven into the bridge to hold the bridge in the elongated state and to delay the transfer of the bridge to the shortened state. In an additional embodiment, there may be one or more central anchors between the proximal and distal anchors with a bridge connecting adjacent anchors.

Abstract: A tubular prosthesis can be formed by rolling a sheet of material about a longitudinal axis, thereby forming a plurality of annular rings that can be arranged so as to be longitudinally adjacent one another, thus forming a tubular prosthesis. Each annular member can expand and contract independent of the other annular members. A graft material can extend between the plurality of annular members.

Abstract: Devices and methods for treating mitral regurgitation by reshaping the mitral annulus in a heart. One preferred device for reshaping the mitral annulus is provided as an elongate body having dimensions as to be insertable into a coronary sinus. The elongate body includes a proximal frame having a proximal anchor and a distal frame having a distal anchor. A ratcheting strip is attached to the distal frame and an accepting member is attached to the proximal frame, wherein the accepting member is adapted for engagement with the ratcheting strip. An actuating member is provided for pulling the ratcheting strip relative to the proximal anchor after deployment in the coronary sinus. In one preferred embodiment, the ratcheting strip is pulled through the proximal anchor for pulling the proximal and distal anchors together, thereby reshaping the mitral annulus.

Abstract: Expandable heart valves for minimally invasive valve replacement surgeries are disclosed. In a first embodiment, an expandable pre-assembled heart valve includes a plastically-expandable annular base having plurality of upstanding commissure posts. A tubular flexible member including a prosthetic section and a fabric section is provided, with the prosthetic section being connected to the commissure posts and defining leaflets therebetween, and the fabric section being attached to the annular base. In a second embodiment, an expandable heart valve includes an annular tissue-engaging base and a subassembly having an elastic wireform and a plurality of leaflets connected thereto. The annular base and subassembly are separately stored and connected just prior to delivery to the host annulus. Preferably, the leaflet subassembly is stored in its relaxed configuration to avoid deformation of the leaflets. The expandable heart valves may be implanted using a balloon catheter.

Abstract: Expandable heart valves for minimally invasive valve replacement surgeries are disclosed. In a first embodiment, an expandable pre-assembled heart valve includes a plastically-expandable annular base having plurality of upstanding commissure posts. A tubular flexible member including a prosthetic section and a fabric section is provided, with the prosthetic section being connected to the commissure posts and defining leaflets therebetween, and the fabric section being attached to the annular base. In a second embodiment, an expandable heart valve includes an annular tissue-engaging base and a subassembly having an elastic wireform and a plurality of leaflets connected thereto. The annular base and subassembly are separately stored and connected just prior to delivery to the host annulus. Preferably, the leaflet subassembly is stored in its relaxed configuration to avoid deformation of the leaflets. The expandable heart valves maybe implanted using a balloon catheter.

Abstract: A deployment catheter for deploying endoluminal vascular prosthesis that has at least a main graft portion and a first branch graft portion includes an elongate, flexible catheter body having a proximal end and a distal end and comprising an outer sheath and an inner core that is axially moveable with respect to the outer sheath. The catheter includes a main graft restraint that has a main graft release mechanism comprising a plurality of axially spaced restraint members. The catheter further includes a branch graft restraint comprising a branch graft release mechanism.

Abstract: A method of treating an aneurysm comprising placing an aspiration catheter in communication with the aneurysm. A prosthesis is deployed across an opening to the aneurysm to isolate at least a portion of the aneurysm. Material is aspirated from the aneurysm. Embolizing or other material may be introduced into the aneurysm.

Abstract: Devices and methods for treating mitral regurgitation by reshaping the mitral annulus in a heart. One preferred device for reshaping the mitral annulus is provided as an elongate body having dimensions as to be insertable into a coronary sinus. The elongate body includes a proximal frame having a proximal anchor and a distal frame having a distal anchor. A ratcheting strip is attached to the distal frame and an accepting member is attached to the proximal frame, wherein the accepting member is adapted for engagement with the ratcheting strip. An actuating member is provided for pulling the ratcheting strip relative to the proximal anchor after deployment in the coronary sinus. In one preferred embodiment, the ratcheting strip is pulled through the proximal anchor for pulling the proximal and distal anchors together, thereby reshaping the mitral annulus.

Abstract: Methods for forming a support frame for flexible leaflet heart valves from a starting blank include converting a two-dimensional starting blank into the three-dimensional support frame. The material may be superelastic, such as NITINOL, and the method may include bending the 2-D blank into the 3-D form and shape setting it. A merely elastic material such as ELGILOY may be used and plastically deformed in stages, possibly accompanied by annealing, to obtain the 3-D shape. Alternatively, a tubular blank could be formed to define a non-tubular shape, typically conical. A method for calculating the precise 2-D blank shape is also disclosed. A mandrel assembly includes a mandrel and ring elements for pressing the blank against the external surface of the mandrel prior to shape setting.

Abstract: A heart valve and tissue repair device for independently, selectively and sequentially grasping heart valve leaflets and independently, selectively and sequentially applying one or more fasteners thereto is disclosed. The device includes a leaflet engaging tip having one or more graspers capable of individually and sequentially grasping leaflets, and one or more deployable fasteners capable of fastening the leaflets. An actuation system for the device individually and selectively controls the graspers and deploys the one or more fasteners. Vacuum pressure from an external vacuum source can be used to grasp the leaflets via a selector system that controls the actuation system so as to individually and sequentially apply vacuum force to the graspers.

Abstract: A method of creating an electronic database record includes receiving input from a user in a computer system to create an electronic database record; determining, upon receiving the input, a template to be used in populating the electronic database record from among several templates; and creating the electronic database record by associating the set of attribute values included in the determined template with the electronic database record. Another embodiment provides a method of processing a database record that comprises, upon accessing the electronic database record, retrieving the set of attribute values included in the template associated with the database record.

Abstract: A heart valve and tissue repair device for independently, selectively and sequentially grasping heart valve leaflets and independently, selectively and sequentially applying one or more fasteners thereto is disclosed. The device includes a leaflet engaging tip having one or more graspers capable of individually and sequentially grasping leaflets, and one or more deployable fasteners capable of fastening the leaflets. An actuation system for the device individually and selectively controls the graspers and deploys the one or more fasteners. Vacuum pressure from an external vacuum source can be used to grasp the leaflets via a selector system that controls the actuation system so as to individually and sequentially apply vacuum force to the graspers.

Abstract: The present system is directed to a method and system to stabilize and repair tissue. At least two opposing devices may be used to stabilize and repair the tissue, with the two devices cooperatively engaging the tissue interposed therebetween. Stabilization may be accomplished by opposing force, vacuum force, or mechanical devices disposed at the distal portion of one or both devices. After the tissue has been stabilized, fasteners may be deployed into the tissue. Fasteners include sutures, clips, and staples. Also disclosed is a minimally invasive method of accessing tissue located within a body and conducting a repair of the area using the system disclosed herein.

Abstract: A method of treating an aneurysm comprising placing an aspiration catheter in communication with the aneurysm. A prosthesis is deployed across an opening to the aneurysm to isolate at least a portion of the aneurysm. Material is aspirated from the aneurysm. Embolizing or other material may be introduced into the aneurysm.

Abstract: An annuloplasty ring having a three-dimensional discontinuous form generally arranged about an axis with two free ends that are axially offset. The ring is particularly suited for repair of the tricuspid valve, and more closely conforms to the annulus shape. The ring is more flexible in bending about radially extending axes than about the central axis. The ring may have an inner structural support covered by a pliable sleeve and/or a fabric tube. The structural support may have a varying cross-section, such as a C-shaped cross-section in a mid-section between two free ends and a rectangular cross-section at the free ends. A deliver template having a mounting ring with about the same shape as the ring facilitates implant, and may be releasably attached to a delivery handle. The deliver template may include a plurality of cutting guides for releasably attaching the annuloplasty ring thereto while presenting maximum outer surface area of the ring.