Abstract: Disclosed are methods, systems, and devices for the endovascular repair of cardiac valves, particularly the atrioventricular valves which inhibit back flow of blood from a heart ventricle during contraction. The procedures described herein can be performed with interventional tools, guides and supporting catheters and other equipment introduced to the heart chambers from the patient's arterial or venous vasculature remote from the heart. The interventional tools and other equipment may be introduced percutaneously or may be introduced via a surgical cut down, and then advanced from the remote access site through the vasculature until they reach the heart.

Abstract: A device for dilating an ostium of a paranasal sinus of a human or animal subject may include: a handle; an elongate shaft having a proximal end coupled with the handle and extending to a distal end; a guidewire disposed through at least a portion of the shaft lumen; a dilator having a non-expanded configuration and an expanded configuration; and a slide member coupled with at least one of the guidewire or the dilator through the longitudinal opening of the shaft for advancing the guidewire and/or the dilator relative to the shaft.

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 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: An irrigation catheter for the treatment of the sinus anatomy is described. The catheter comprises a proximal portion, a rigid middle portion, and a flexible distal portion. The flexible distal portion comprises an irrigation tip and the proximal portion has a stiffness that is intermediate the stiffness of the rigid middle portion and the flexible distal portion. The irrigation tip has a tip opening and one or more radially facing openings. A method for irrigating or suctioning the sinus anatomy includes inserting an irrigation catheter into a patient's anatomy and irrigating or suctioning a target space.

Abstract: The invention is an endoscopic method for viewing a target portion of a patient's anatomy with access through the oral or nasal cavity. The method includes adjusting a variable direction of view endoscope to a direction of view of between about 0 degrees and 20 degrees relative to a longitudinal axis of the endoscope and a shaft orientation pointing toward the target portion of the patient's anatomy. The endoscope is then introduced straight into the oral or nasal cavity of a patient until the endoscope is positioned in the back of the cavity. The direction of view is adjusted to view the target portion of the patient's anatomy.

Abstract: A medical device, and a system and packaged kit containing the medical device for the treatment of a sinus opening is described. The medical device comprises a proximal end, a distal end, and a shaft system having an inflation lumen and an irrigation lumen the proximal and. The shaft system has a proximal shaft section and a distal shaft section. An inflatable balloon is attached to the distal shaft section in a position that is proximal to said distal end. The irrigation tip is distal to the balloon on the distal shaft section and has a tip opening and one or more radially facing openings. A method for treating a sinus opening includes inserting a system that includes the medical device, a sinus guide catheter and a sinus guide element into a patient's anatomy, dilating the sinus opening and irrigating a target in the nasal anatomy.

Abstract: Disclosed are devices and methods for treating regurgitation through a valve in the heart. The devices can include an expandable, fluid-tight bladder configured to be deployed between valve leaflets of the heart valve. The bladder can include an upper portion that extends into the atrium of the heart; a lower portion that extends into the ventricle of the heart; and a middle portion positionable within the line of valve leaflet coaptation that provides a sealing surface for one or more of the leaflets.

Abstract: Methods and devices for providing a gas pathway between the nasopharynx and the Eustachian tube are provided. One device may include a lumen with a valve. A portion of the valve may be tethered to adjacent muscle. Another portion of the valve may be tethered to adjacent cartilage. When the muscle contracts the valve may open through movement of the tethers, and provide a gas pathway between the nasopharynx and the Eustachian tube.

Abstract: Systems and methods for treating a patient having a head with a first ear and a second ear, function by mounting a support structure to the head of the patient; aligning the support structure with a target tissue in an ear canal of the first ear; stabilizing the support structure relative to the target tissue by injecting a material into the canal and hardening the material; and actuating a device while the device is supported by the support system so that the device therapeutically remodels the target tissue of the first ear.

Abstract: A device for dilating an ostium of a paranasal sinus of a human or animal subject may include: a handle; an elongate shaft having a proximal end coupled with the handle and extending to a distal end; a guidewire disposed through at least a portion of the shaft lumen; a dilator having a non-expanded configuration and an expanded configuration; and a slide member coupled with at least one of the guidewire or the dilator through the longitudinal opening of the shaft for advancing the guidewire and/or the dilator relative to the shaft.

Abstract: A variable direction of view endoscope is positionable at desired locations within the ear, nose, throat, paranasal sinuses or cranium to accomplish visualization. A method of use includes introducing the variable direction of view endoscope into a nasal cavity with the endoscope adjusted to a first direction of view between about 0 degrees and about 15 degrees relative to a longitudinal axis of the endoscope. A therapeutic device is introduced into the nasal cavity and the endoscope is adjusted to a second direction of view directed toward the sinus opening or passageway. The method also includes advancing the therapeutic device into or through the sinus opening and viewing at least one of the sinus opening or passageway or the therapeutic device using the endoscope adjusted to the second direction of view.

Abstract: Devices and methods are provided for tissue approximation and repair. Fixation devices comprise a pair of elements each having a first end, a free end opposite the first end, and an engagement surface therebetween for engaging the tissue, the first ends being moveable between an open position wherein the free ends are spaced apart and a closed position wherein the free ends are closer together with the engagement surfaces generally facing each other. The fixation devices include a locking mechanism coupled to the elements for locking the elements in place. The devices and methods find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions. The invention is particularly useful in 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: Systems and methods for treating a patient having a head with a first ear and a second ear function by mounting a support system to the head of the patient so that the support system is aligned with a target tissue of the first ear; applying a therapeutic agent to the first car by energizing an iontophoresis electrode supported by the support system; and actuating a device while the device is supported by the support system so that the device therapeutically remodels the target tissue of the first ear.

Abstract: Devices, systems and methods are provided for tissue approximation and repair at treatment sites, particularly in those procedures requiring minimally-invasive or endovascular access to remote tissue locations. Fixation devices are provided to fix tissue in approximation with the use of distal elements. In some embodiments, the fixation devices have at least two distal elements and an actuatable feature wherein actuation of the feature varies a dimension of the at least two distal elements. In other embodiments, the fixation devices have at least two pairs of distal elements wherein the pairs of distal elements are moveable to engage tissue between opposed pairs of distal elements. Systems are also provided having fixation devices and accessories.

Abstract: Medical devices, systems and methods that are useable to facilitate transnasal insertion and positioning of guidewires and various other devices and instruments at desired locations within the ear, nose, throat, paranasal sinuses or cranium. Direct viewing of such placements via an endoscope.

Abstract: Devices and methods wherein an adapter is used to attach an electromagnetic image guidance component to a medical device such that an electromagnetic image guidance system may be used to track the location of the medical device within the body of a human or animal subject.

Abstract: Systems and methods for treating a patient having a head with a first ear and a second ear function by mounting a support system to the head of the patient so that the support system is aligned with a target tissue of the first ear; applying a therapeutic agent to the first ear by energizing an iontophoresis electrode supported by the support system; and actuating a device while the device is supported by the support system so that the device therapeutically remodels the target tissue of the first ear.

Abstract: Medical devices, systems and methods that are useable to facilitate transnasal insertion and positioning of guidewires and various other devices and instruments at desired locations within the ear, nose, throat, paranasal sinuses or cranium.

Abstract: The methods, devices, and systems are provided for performing endovascular repair of atrioventricular and other cardiac valves in the heart. Regurgitation of an atrioventricular valve, particularly a mitral valve, can be repaired by modifying a tissue structure selected from the valve leaflets, the valve annulus, the valve chordae, and the papillary muscles. These structures may be modified by suturing, stapling, snaring, or shortening, using interventional tools which are introduced to a heart chamber. Preferably, the tissue structures will be temporarily modified prior to permanent modification. For example, opposed valve leaflets may be temporarily grasped and held into position prior to permanent attachment.