Abstract: The invention generally relates to an intravascular catheter that includes a proximal hub and a distal elongated tubular member. In one embodiment, the hub is designed to mitigate the introduction of air into a patient's vasculature during the delivery of a second device through the catheter into the patient's body.

Abstract: Devices and methods for performing a transeptal puncture procedure are described. In certain embodiments, the device includes a blunt outer needle, and a second inner needle disposed longitudinally through the lumen of the outer needle, wherein the inner needle is flexible, e.g., has a flexible portion and/or a bend or other non-traumatic conformation at its tip.

Abstract: Devices and methods for performing a transeptal puncture procedure are described. In certain embodiments, the device includes a blunt outer needle, and a second inner needle disposed longitudinally through the lumen of the outer needle, wherein the inner needle is flexible, e.g., has a flexible portion and/or a bend or other non-traumatic conformation at its tip.

Abstract: The embodiments of the present invention provide a device that modifies the left atrial appendage (LAA) to reduce the likelihood of thrombus formation therein. The device includes a liner that reduces the volume of the LAA and remodels the interior geometry and surfaces of the LAA thereby minimizing the crenellations in the LAA that impede blood flow. According to some embodiments, the device further includes an anchor component. The anchor component helps to expand the liner upon deployment of the device in-vivo and further prevents dislodgement and migration of the device, by ensuring the device is properly seated and completely sealed against the walls and ostium of the LAA.

Abstract: A welding element is provided for applying heat, chemicals, pressure, or any combination thereof to tissues inside a patient's body, e.g., a patent foramen ovale. In one aspect, the welding element is connected to a radio frequency energy source and includes an electrode and a locator. The locator facilitates positioning of the welding element and is capable of moving from an open position to a clamping position. In another aspect, a needle is provided for transseptal puncturing before the application of heat. In yet another aspect, the welding element is configured as a coil. The welding element can be made of Nitinol.

Abstract: A welding element is provided for applying heat, chemicals, pressure, or any combination thereof to tissues inside a patient's body, e.g., a patent foramen ovale. In one aspect, the welding element is connected to a radio frequency energy source and includes an electrode and a locator. The locator facilitates positioning of the welding element and is capable of moving from an open position to a clamping position. In another aspect, a needle is provided for transseptal puncturing before the application of heat. In yet another aspect, the welding element is configured as a coil. The welding element can be made of Nitinol.

Abstract: A delivery/recovery system to allow an operator to deploy and recover a medical implant, such as an occluder for closing a patent foramen ovale (PFO). In one embodiment, the system includes a delivery mandrel for preventing the occluder from moving in the proximal direction, a delivery wire for securing the occluder to the delivery mandrel and preventing unwanted movement in the distal direction, and a sheath for enveloping the delivery wire, mandrel and occluder. By moving the sheath relative to the occluder in a series of steps, the occluder opens first on a distal side and then on a proximal side, in a manner that holds the occluder in place.

Abstract: A delivery/recovery system to allow an operator to deploy and recover a medical implant, such as an occluder for closing a patent foramen ovale (PFO). In one embodiment, the system includes a delivery mandrel for preventing the occluder from moving in the proximal direction, a delivery wire for securing the occluder to the delivery mandrel and preventing unwanted movement in the distal direction, and a sheath for enveloping the delivery wire, mandrel and occluder. By moving the sheath relative to the occluder in a series of steps, the occluder opens first on a distal side and then on a proximal side, in a manner that holds the occluder in place.

Abstract: The present invention provides systems and methods for occluding or closing a patent foramen ovale of a patient (PFO). The invention includes a catheter carrying an energy delivery element. The catheter introduces the energy delivery element into the patent foramen ovale of a patient's heart. Once appropriately positioned, the energy delivery element applies energy, such as radiofrequency energy, to the tissues surrounding the patent foramen ovale. The application of energy causes the tissues to join together, occluding the patent foramen ovale. The energy delivery element may be removable or permanently implanted in the patent foramen ovale.

Abstract: An implant for occluding a septal defect, such as a patent foramen ovale (PFO), and methods of delivering the implant are described. The implant includes a scaffold, at least one channel, and an injection port in fluid communication with the channels for inflating the scaffold.

Abstract: The present invention provides systems and methods for occluding or closing a patent foramen ovale of a patient (PFO). The invention includes a catheter carrying an energy delivery element. The catheter introduces the energy delivery element into the patent foramen ovale of a patient's heart. Once appropriately positioned, the energy delivery element applies energy, such as radiofrequency energy, to the tissues surrounding the patent foramen ovale. The application of energy causes the tissues to join together, occluding the patent foramen ovale. The energy delivery element may be removable or permanently implanted in the patent foramen ovale.

Abstract: Devices and methods for performing a transeptal puncture procedure are described. In certain embodiments, the device includes a blunt outer needle, and a second inner needle disposed longitudinally through the lumen of the outer needle, wherein the inner needle is flexible, e.g., has a flexible portion and/or a bend or other non-traumatic conformation at its tip.

Abstract: Devices and methods for performing a transeptal puncture procedure are described. In certain embodiments, the device includes a blunt outer needle, and a second inner needle disposed longitudinally through the lumen of the outer needle, wherein the inner needle is flexible, e.g., has a flexible portion and/or a bend or other non-traumatic conformation at its tip.

Abstract: The invention relates to devices, systems, and methods for percutaneously suturing biological material, such as a patient's tissues. In one embodiment, a suturing device includes first and second tissue engaging members connected to one another by a first interconnecting member. In another embodiment, systems and methods are provided for forming holes through two overlapping layers of tissue. Subsequent to forming holes through the two layers of tissue, the suturing device is positioned through the holes to join or bring into contact the two layers of overlapping tissue.

Abstract: Devices and methods for performing a transeptal puncture procedure are described. In certain embodiments, the device includes a blunt outer needle, and a second inner needle disposed longitudinally through the lumen of the outer needle, wherein the inner needle is flexible, e.g., has a flexible portion and/or a bend or other non-traumatic conformation at its tip.

Abstract: The present invention provides a device for occluding an anatomical aperture, such as an atrial septal defect (ASD) or a patent foramen ovale (PFO). The occluder includes two sides connected by a central tube. A tissue scaffold material is disposed on the occluder. The occluder is formed from a tube, which is cut to produce struts in each side. Upon the application of force, the struts deform into loops. The loops may be of various shapes, sizes, and configurations, and, in at least some embodiments, the loops have rounded peripheries. In some embodiments, at least one side of the occluder includes a tissue scaffold. The occluder further includes a catch system that maintains its deployed state in vivo. When the occluder is deployed in vivo, the two sides are disposed on opposite sides of the septal tissue surrounding the aperture and the catch system is deployed so that the occluder exerts a compressive force on the septal tissue and closes the aperture.

Abstract: The present invention provides methods and devices for closing two overlapping layers of tissue in a mammalian heart, for example a patent foramen ovale (PFO). The closure devices may take a number of different forms and may be retrievable. In some embodiments, a device is sized and shaped to extend from septum secundum, into the left atrium, through septum primum, and into the right atrium, such that the first and second ends cooperate to provide a compressive force to the overlapping layers of tissue. In some embodiments, the closure devices may be delivered with a catheter capable of puncturing mammalian tissue.

Abstract: The invention provides an intracardiac occluder, which has biological tissue scaffolds as occlusion shells, for the percutaneous transluminal treatment of an intracardiac defect. The intracardiac occluder includes a proximal support structure supporting the proximal occlusion shell and a distal support structure supporting the distal occlusion shell. In one embodiment, biological tissue derived from the tunica submucosa layer of the porcine small intestine forms the occlusion shells.

Abstract: The present invention provides methods and devices for sealing intracardiac defects, such as a patent foramen ovale (PFO) utilizing an electrode positioned in the lumen of the defect such as the tunnel of a PFO.

Abstract: The present invention provides systems and methods for occluding or closing a patent foramen ovale of a patient (PFO). The invention includes a catheter carrying an energy delivery element. The catheter introduces the energy delivery element into the patent foramen ovale of a patient's heart. Once appropriately positioned, the energy delivery element applies energy, such as radiofrequency energy, to the tissues surrounding the patent foramen ovale. The application of energy causes the tissues to join together, occluding the patent foramen ovale. The energy delivery element may be removable or permanently implanted in the patent foramen ovale.