Abstract: A bulbous valvuloplasty balloon is described that maintains its bulbous shape in its final deployed configuration along with the method of use for post dilation of a TAVR device. The bulbous balloon has two larger diameter bulb segments located on each side of a smaller diameter waist and can be used to post dilate a TAVR device that has been implanted at the site of a stenotic aortic valve. The post dilation causes deformation of the underlying tissues residing outside of the TARV stent structure.

Abstract: Some embodiments of pacing systems employ wireless electrode assemblies to provide pacing therapy. The wireless electrode assemblies may wirelessly receive energy via an inductive coupling so as to provide electrical stimulation to the surrounding heart tissue. In certain embodiments, the wireless electrode assembly may include one or more biased tines that shift from a first position to a second position to secure the wireless electrode assembly into the inner wall of the heart chamber.

Abstract: Some embodiments of pacing systems employ wireless electrode assemblies to provide pacing therapy. The wireless electrode assemblies may wirelessly receive energy via an inductive coupling so as to provide electrical stimulation to the surrounding heart tissue. In certain embodiments, the wireless electrode assembly may include one or more biased tines that shift from a first position to a second position to secure the wireless electrode assembly into the inner wall of the heart chamber.

Abstract: Various configurations of systems that employ leadless electrodes to provide pacing therapy are provided. In one example, a system that provides multiple sites for pacing of myocardium of a heart includes wireless pacing electrodes that are implantable at sites proximate the myocardium using a percutaneous, transluminal, catheter delivery system. Each of the electrodes contains a source of electrical energy for pacing the myocardium and is adapted to receive electromagnetic energy from a source outside the myocardium. The system also includes a source adapted for placement outside the myocardium and that uses locally measured electrocardiograms to synchronize pacing of the heart by sending electromagnetic commands to the electrodes to pace the myocardium surrounding the electrodes. Also disclosed is various configurations of such systems, wireless electrode assemblies, and delivery catheters for delivering and implanting the electrode assemblies.

Abstract: A cardiac valve with a support frame having a first end member and a second end member opposing the first end member in a substantially fixed distance relationship, and a cover extending over the support frame to allow for unidirectional flow of a liquid through the valve.

Abstract: Various configurations of systems that employ leadless electrodes to provide pacing therapy are provided. In one example, a system that provides multiple sites for pacing of myocardium of a heart includes wireless pacing electrodes that are implantable at sites proximate the myocardium using a percutaneous, transluminal, catheter delivery system. Each of the electrodes contains a source of electrical energy for pacing the myocardium and is adapted to receive electromagnetic energy from a source outside the myocardium. The system also includes a source adapted for placement outside the myocardium and that uses locally measured electrocardiograms to synchronize pacing of the heart by sending electromagnetic commands to the electrodes to pace the myocardium surrounding the electrodes. Also disclosed is various configurations of such systems, wireless electrode assemblies, and delivery catheters for delivering and implanting the electrode assemblies.

Abstract: A venous valve with a frame and a cover on the frame for unidirectional flow of a liquid through the valve.

Abstract: An apparatus for locally controlling smooth muscle tone includes a first electrode for insertion into an artery; a barrier for preventing the first electrode from contacting an arterial wall; a second electrode; a power supply; and a controller for coupling the power supply to the electrodes. The controller is configured to cause the electrode to maintain a waveform for controlling polarization of smooth muscle tone.

Abstract: A venous valve with a frame and a cover on the frame for unidirectional flow of a liquid through the valve.

Abstract: A thrombectomy system may include an elongate shaft that defines a high pressure lumen and a low pressure lumen. The high pressure lumen may terminate near an end of the low pressure lumen. An expandable capture basket may be disposed near the end of the low pressure lumen. A thrombectomy apparatus may include an elongate shaft, an evacuation lumen extending within the elongate shaft and a high pressure lumen extending within the elongate shaft. A capture apparatus may be disposed within a wire lumen that extends within the elongate shaft such that the capture apparatus extends distally from the wire lumen.

Abstract: Apparatus, systems, and methods for percutaneous valve replacement and/or augmentation are provided. The apparatus includes a valve having a valve frame, a valve leaflet coupled to the valve frame, and a leaflet transition member coupled to the valve leaflet. The valve leaflet and leaflet transition member can transition from a first position where the valve leaflet and leaflet frame are at least partially outside a lumen of the valve frame to a second position where the valve leaflet and the leaflet transition member are within the lumen of the valve frame.

Abstract: A thrombectomy system may include an elongate shaft that defines a high pressure lumen and a low pressure lumen. The high pressure lumen may terminate near an end of the low pressure lumen. An expandable capture basket may be disposed near the end of the low pressure lumen. A thrombectomy apparatus may include an elongate shaft, an evacuation lumen extending within the elongate shaft and a high pressure lumen extending within the elongate shaft. A capture apparatus may be disposed within a wire lumen that extends within the elongate shaft such that the capture apparatus extends distally from the wire lumen.

Abstract: Devices, systems, and methods are provided to treat diseased cardiac valves. The device includes a percutaneous heart valve having an expandable valve frame including valve frame members, a valve leaflet coupled to the valve frame, and an expandable stent anchoring frame coupled to the valve frame including stent frame members defining a first portion and a second portion having greater flexibility than the first portion, where the first portion and the valve frame define a length, and where the stent frame members and the valve frame members along the length provide a contiguous surface over which a delivery device can repeatedly slide over the length in its entirety in two longitudinal directions when the first portion and the valve frame are in a partially expanded state during delivery from the delivery device.

Abstract: A filter system, comprising an elongate filter body defining a lumen and having a proximal end and a distal end. A valve can be provided defining a lumen and having a reversibly sealable opening for unidirectional flow of a fluid through the lumen. The valve can be adjoined proximal the distal end of the elongate filter body, wherein the elongate filter body filters the unidirectional flow of the fluid passing through the lumen of the valve and the lumen of the elongate filter body.

Abstract: A filter system, comprising an elongate filter body defining a lumen and having a proximal end and a distal end. A valve can be provided defining a lumen and having a reversibly sealable opening for unidirectional flow of a fluid through the lumen. The valve can be adjoined proximal the distal end of the elongate filter body, wherein the elongate filter body filters the unidirectional flow of the fluid passing through the lumen of the valve and the lumen of the elongate filter body.

Abstract: A measuring balloon has an inner bulbous balloon formed from a non-compliant or semi-compliant material and has a central smaller diameter inner waist and two larger diameter bulbs on each side of the inner waist. A compliant outer waist bladder is located on the outside of the inner bulbous balloon adjacent to the inner waist and is inflated via a separate inflation lumen. The inner balloon is inflated at a higher pressure to dilate stenotic aortic valve leaflets, and provide alignment and positioning of the measuring balloon across the aortic annulus. The bladder waist is inflated to a lower pressure to make contact with the aortic valve annulus. Marker bands positioned on the outside of the measuring balloon provide determination of annulus diameter and ovality.

Abstract: A balloon catheter is used for dilating tubular members of the body such as dilating stenotic aortic valve leaflets found in the aortic root, and measuring the shape and dimensions of the annulus. The balloon has two larger diameter bulbous regions; one is positioned in the left ventricular outflow tract (LVOT) and the other in the aortic sinus; a smaller diameter waist region is positioned across the aortic annulus. During inflation of the balloon, the balloon waist expands in diameter until it comes into contact with the aortic annulus. The balloon pressure and inflation volume is monitored during inflation so that an inflection point in the dP/dV curve is seen at the point of contact of the waist with the annulus. Radiopaque rings and/or marker bands in the device allow the size and orientation of the elliptical annulus to be calculated.

Abstract: A device is described for crossing the atrial septum to properly size a valve annulus for treatment or replacement, having a catheter with an expandable braided tubular structure attached at its distal end. The proximal and distal end regions of the braided tube have an open structure to allow blood flow to pass freely through the gaps or spaces between the braided fibers. The lumen within the tube includes a temporary, artificial valve that acts similar to a native valve, allowing blood to flow in one direction and preventing blood flow in the opposite direction.

Abstract: A venous valve with a frame and a cover on the frame for unidirectional flow of a liquid through the valve.

Abstract: An apparatus and method for closing an arteriotomy site are disclosed which may employ the use of a delivery sheath within which is provided an anchoring device formed of memory metal wherein the anchoring device can be extended into the blood vessel itself. The memory metal, has a linear insertion configuration and obtains a non-linear or coiled configuration which can then be pulled back against the inner surface of the blood vessel to form a backstop. A biodegradable plug is then introduced into the tissue tract until it engages the backstop thereby ensuring proper positioning of the biodegradable plug. The anchoring device can then be retracted through the biodegradable plug leaving the arteriotomy site substantially closed with hemostasis being formed therearound.