Systems and methods for separating native heart valve leaflets attached together by a fixation device. The system has elongate shaft including a proximal end portion, a distal end portion and a longitudinal axis extending therebetween. The elongate shaft is configured for transvascular delivery of the distal end portion to a native heart valve. A balloon is disposed at the distal end portion of the elongate shaft, and the balloon is inflatable from a collapsed condition to an inflated condition. At least one snare lumen extends along at least a portion of the balloon, the at least one snare lumen having an exit port defined therein. A snare is deployable through the exit port from a delivery position within the at least one snare lumen to an extended position extending beyond the exit port. The snare in the extended position is configured to capture the fixation device.

A catheter system for treating a treatment site within or adjacent to a vessel wall or a heart valve, includes a light source, a balloon, a light guide and an optical analyzer assembly. The light source generates first light energy. The balloon is positionable substantially adjacent to the treatment site. The balloon has a balloon wall that defines a balloon interior that receives a balloon fluid. The light guide receives the first light energy and guides the first light energy in a first direction from a guide proximal end toward a guide distal end positioned within the balloon interior. The optical analyzer assembly optically analyzes a second light energy from the light guide that moves in a second direction that is opposite the first direction. The optical analyzer assembly includes a safety shutdown system to inhibit the first light energy from being received by the guide proximal end of the light guide.

The invention is a device, system, and method for repairing heart valve function, which may include bisecting native valve leaflets for improved deployment of a prosthetic heart valve in the native valve annulus. The invention may include a catheter having a cutting element shaft with a cutting element configured to puncture a valve leaflet and/or make a controlled cut through the leaflet. The device may have an extendable foot configured to be positioned on an opposite side of the valve leaflet from the cutting element shaft. The device may include magnets to guide the cutting element and/or cutting element shaft in proper alignment with the extendable foot and to hold the elements in place during leaflet bisection.

Prosthetic valves and associated methods and systems are disclosed, including a prosthetic valve with a support structure and a leaflet construct coupled to the support structure, and a tissue cutting element coupled to a portion of the prosthetic valve.

A catheter for intraluminal lithotripsy including a first lumen, an energy delivery member supported by the catheter body. The energy delivery member includes a passageway, a valve positioned in the passageway and an energy emitter configured to communicate energy to target tissue. A method for performing intraluminal lithotripsy is also disclosed.

A transseptal insertion device is provided including device housing, a pusher slidably disposed in the device housing and a guide element extending from the pusher. The device housing is configured to be inserted into the right atrium of a patient's heart and the guide element can then be advanced from the device housing and against the cardiac septum to facilitate stable puncturing of the cardiac septum by a needle carried by a catheter inserted through the device housing, to provide access to the left atrium. The guide element can be formed as a webbing or ring. The pusher and/or guide element can optionally be inflatable.

A catheter system (100) includes an inflatable balloon (104), an optical fiber (122), and a laser (124). The optical fiber (122) has a distal end positioned within the inflatable balloon (104). The optical fiber (122) receives an energy pulse (431) to emit light energy in a direction away from the optical fiber (122) to generate a plasma pulse (134) within the inflatable balloon (104). The laser (124) includes a seed source (126) that emits a seed pulse (342) and an amplifier (128) that increases energy of the seed pulse (342) so that the laser (124) generates the energy pulse (431) that is received by the optical fiber (122), the energy pulse (431) having a waveform with a duration T, a minimum power PO, a peak power PP, and a time from PO to PP equal to TP.

An interventional device for cutting tissue at a targeted cardiac valve, such as a mitral valve. The interventional device includes a catheter having a proximal end and a distal end. A cutting mechanism is positionable at the distal end, such as by routing the cutting mechanism through the catheter to position it at the distal end. The cutting mechanism includes one or more cutting elements configured for cutting valve tissue when engaged against the tissue. A handle is coupled to the proximal end of the catheter and includes one or more controls for actuating the cutting mechanism.

A catheter system (100) for treating a treatment site (106) within or adjacent to a vessel wall (108A) or a heart valve includes a light source (124), a first light guide (122A), a second light guide (122A), and a guide bundle (152). The light source (124) generates light energy. The first light guide (122A) receives the light energy from the light source (124) and has a guide proximal end (122P). The second light guide (122A) receives the light energy from the light source (124) and has a guide proximal end (122P). A guide bundle (152) is in optical communication with the light source (124). The guide bundle (152) bundles the first light guide (122A) and the second light guide (122A). The guide bundle (152) includes a first ferrule (778) that engages the guide proximal end (122P) of the first light guide (122A) and a second ferrule (778) that engages the guide proximal end (122P) of the second light guide (122A). At least one of the ferrules (778) can be formed at least partially from a ceramic material or a metallic material.

Methods and tools for implanting prosthetic heart valves and modifying leaflets of an existing valvular structure in a subject are disclosed herein. Prior to or during implantation of the prosthetic heart valve within the existing valvular structure, each tool can be provided in the ascending aorta (or equivalent thereof) of a subject and can be used to pierce, lacerate, slice, tear, cut or otherwise modify a leaflet or commissure of the existing valvular structure. The existing valvular structure can be a native aortic valve or other native heart valve, or a previously-implanted prosthetic heart valve. The modification can avoid, or at least reduce the likelihood of, issues that leaflets of the existing valvular structure might otherwise cause once the prosthetic heart valve has been fully installed, for example, obstruction of blood flow to the coronary arteries and/or improper valve mounting due to a non-circular cross-section.