Abstract: A procedural sheath and methods of use that assists in maintaining a fluid path while the procedural sheath is positioned within a vascular conduit of a patient. The procedural sheath includes one or more channels extending longitudinally along a working length of the body of the sheath. Each channel includes one or more fluid paths configured to allow blood to flow from the vascular conduit into a device receiving lumen of the sheath. One or more elongate members selectively coupled to the body operatively cooperate with the channels to fluidly control fluid access into the device receiving lumen through the fluid paths.

Abstract: A medical device includes a balloon expanded scaffold (or stent) crimped to a catheter having a balloon. The scaffold is crimped to the balloon by a process that includes using protective polymer sheaths or sheets during crimping, and resetting the sheaths or sheets during the crimping to avoid or minimize interference between the polymer material and scaffold struts as the scaffold is reduced in size. Balloon pressure is adjusted when the polymer material is reset.

Abstract: The invention provides medical devices, systems and methods for tissue approximation and repair and in particular to reduce mitral regurgitation by means of improved coaptation. The devices, systems and methods of the invention will find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions, including the cardiovascular system, heart, other organs, vessels, and tissues. The invention is particularly useful in those procedures requiring minimally-invasive or endovascular access to remote tissue locations, where the instruments utilized must negotiate long, narrow, and tortuous pathways to the treatment site.

Abstract: A method for managing a guidewire in preparation for a surgical operation, comprising attaching a block of resilient polymer to a coiled tube which contains a guidewire; attaching to the block of resilient polymer a card having printed information concerning the guidewire on a planar surface of the card; removing the guidewire from the coiled tube; removing the block of resilient polymer from the coiled tube while keeping the card having printed information attached to the block of resilient polymer; coiling the guidewire into a flat spiral form; capturing, in a slot formed in the block of resilient polymer, a plurality of portions of the guidewire, which portions are adjacent to and parallel with each other, thereby maintaining the guidewire in the flat spiral form.

Abstract: Various embodiments of the systems, methods and devices are provided comprising angioplasty to break up calcification or other tissue in occlusive areas within a blood vessel. The various embodiments disclosed include pressure pulse periods designed to break up calcified occlusive material through a cyclically stretching of the vessel walls without damaging the vessel wall tissue.

Abstract: The present disclosure describes tissue gripping devices, systems, and methods for gripping mitral valve tissue during treatment of a mitral valve and while a tissue fixation device is implanted in the mitral valve. The tissue gripping device includes a flexible member and one or more tissue gripping members coupled to one or more arms of the flexible member. The flexible member is formed from a shape-memory material, such as nitinol, and the tissue gripping member(s) are formed from a material that is more rigid than the shape-memory material. The tissue gripping member(s) are attached to the flexible member by threading or looping suture lines around and/or through the tissue gripping member(s) and the flexible member and/or by applying a cover material to the tissue gripping device to hold the tissue gripping member(s) against the flexible member.

Abstract: A rotational atherectomy device may include a flexible, elongated, rotatable drive shaft with a system of eccentric abrading heads attached thereto. At least part of the eccentric enlarged abrading heads have a tissue removing surface—typically an abrasive surface. The abrading heads may be at least partially hollow. Preferably the eccentric enlarged abrading heads have centers of mass spaced radially from the rotational axis of the drive shaft, enabling the eccentric abrading heads to work together to open a stenotic lesion to a diameter substantially larger than the outer resting diameter of the enlarged abrading heads when operated at high speeds. The system of eccentric abrading heads may have unbalanced centers of mass to stimulate greater rotational diameters and may be arranged in a manner providing a debris-removing augering effect. Alternatively, a rotational atherectomy device may include a system of eccentric abrading heads with balanced centers of mass.

Abstract: An expandable stent for implantation in a body lumen, such as an artery, is disclosed. The stent consists of a plurality of radially expandable cylindrical rings generally aligned on a common longitudinal stent axis and interconnected by one or more interconnecting links placed so that the stent is flexible in the longitudinal direction. The link pattern is optimized to enhance longitudinal flexibility and high longitudinal strength compression of the stent.

Abstract: A torque device for gripping and manipulating a guidewire for advancing the guidewire into a patient's vascular system. The torque device is configured for single-handed use and can be opened for repositioning the torque device relative to the guidewire and closed for gripping the guidewire to prevent axial and rotational movement relative to the guidewire. The torque device grips the guidewire at multiple spaced apart locations on the guidewire.

Abstract: A device for adjusting a shape of a coronary sinus in a heart of a patient, the device comprising a flexible tube having: an outer wall extending between a proximal end and a distal end; a first bore extending from the proximal end to the distal end; a proximal flange attached to the proximal end; a distal flange attached to the distal end; wherein, the outer wall includes at least one accordion-like hinge region.

Abstract: The invention provides devices, systems and methods for tissue approximation and repair at treatment sites. The devices, systems and methods of the invention will find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions, including the abdomen, thorax, cardiovascular system, heart, intestinal tract, stomach, urinary tract, bladder, lung, and other organs, vessels, and tissues. The invention is particularly useful in those procedures requiring minimally-invasive or endovascular access to remote tissue locations, where the instruments utilized must negotiate long, narrow, and tortuous pathways to the treatment site. In addition, many of the devices and systems of the invention are adapted to be reversible and removable from the patient at any point without interference with or trauma to internal tissues.

Abstract: Devices for closing a passage through tissue communicating with a body lumen. The device may include an elongate body, a sheath disposed at the distal end of the device for disposition within a body lumen, a hollow needle disposed within a needle lumen of the body, the needle being selectively advancable through the needle lumen, a suture-anchor ejection mandrel disposed within the hollow needle that is also selectively advancable through the hollow needle, a suture-anchor and suture disposed within the hollow needle, a distal end of the suture attached to the suture anchor for ejection out the hollow needle by the mandrel. A needle guide disposed between the sheath and proximal end of the body may include a needle port through which the needle can exit. A hemostatic plug is disposed over the needle port so as to be penetrated by the needle upon exiting the port.

Abstract: Devices and methods for providing an elastically deforming guidewire tip, capable of withstanding the extreme forces of high-speed rotational atherectomy, in particular orbital motion induced by an eccentric abrasive head, are disclosed. In certain embodiments, the reformable tip comprises an inner nitinol support coil, wherein the reformable tip may be attached to a larger proximal core for improved kink resistance and support for delivering adjunctive devices. In other embodiments, an inner nitinol support coil may be wrapped with a braided coil and/or a polymer sleeve. The resulting tip is more flexible with reduced risk of perforation than known guidewire tips.

Abstract: The invention provides devices, systems and methods for tissue approximation and repair at treatment sites. The devices, systems and methods of the invention will find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions, including the abdomen, thorax, cardiovascular system, heart, intestinal tract, stomach, urinary tract, bladder, lung, and other organs, vessels, and tissues. The invention is particularly useful in those procedures requiring minimally-invasive or endovascular access to remote tissue locations, where the instruments utilized must negotiate long, narrow, and tortuous pathways to the treatment site. In addition, many of the devices and systems of the invention are adapted to be reversible and removable from the patient at any point without interference with or trauma to internal tissues.

Abstract: A suture management member including a body being elongate in a first direction and having a suture-receiving recess in a second direction transverse to the first direction. The suture-receiving recess extends partially through the body and separates the body into a first portion and a second portion. The first portion is being biased towards the second portion to securely retaining a suture within the suture-receiving recess.

Abstract: A thrombectomy system is provided that, in various embodiments, a rotating impeller that may be translated within limits along a guidewire and within a catheter. The rotating impeller is, during operation, either located entirely outside of the distal end of the catheter's lumen or at least partially outside of the distal end of the catheter's lumen, whereby rotation is prevented if the impeller is completely within the catheter's lumen.

Abstract: Assessing a risk associated with implantation of a drug delivery device configured to treat blood vessels, is described. Particularly, devices, methods, and systems for assessing the risk of stent thrombosis, prior to implantation, for determining the appropriate stent and/or medication regimen for a particular patient, and continuing to assess the risk of stent thrombosis after implantation, thereby improving the efficacy of the therapy, are described. Other embodiments are described and claimed.

Abstract: A suturing system is provided. In an embodiment, the suturing system includes a sheath having a proximal end and a distal end. A needle is disposed distal the sheath in a pre-deployed configuration with a needle tip of the needle being orientated proximally towards the sheath. A body is disposed within the sheath, the body comprising a guide reducing an outer cross-sectional dimension of the body at the guide and forming a space between the body and the sheath, the guide being configured to receive the needle and direct the needle proximally toward the proximal end of the sheath. A suture is attached to the needle.

Abstract: The invention provides devices, systems and methods for tissue approximation and repair at treatment sites. The devices, systems and methods of the invention will find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions, including the abdomen, thorax, cardiovascular system, heart, intestinal tract, stomach, urinary tract, bladder, lung, and other organs, vessels, and tissues. The invention is particularly useful in those procedures requiring minimally-invasive or endovascular access to remote tissue locations, where the instruments utilized must negotiate long, narrow, and tortuous pathways to the treatment site. In addition, many of the devices and systems of the invention are adapted to be reversible and removable from the patient at any point without interference with or trauma to internal tissues.

Abstract: The present invention provides an intravascular blood pump comprising a housing that is at least partially expandable and collapsible and having an impeller with one or more blades attached thereto. The housing having spanning sections that are aligned with the blade(s) and adapted to collapse into recesses or spaces defined or provided between or along the blade(s) and along the central rotor to which the blade(s)s are attached.