A device for fracturing calcifications in heart valves includes a stabilizer and an impactor movable towards each other. The impactor includes one or more impactor arms, each of which extends distally from a proximal cap. The impactor further includes one or more lever arms each of which is distally coupled to a lever cap and proximally coupled to a corresponding one of the one or more impactor arms. The lever cap slides on a shaft which extends towards the proximal cap. Proximal movement of the lever cap towards the proximal cap causes the one or more lever arms to deform and to push against the one or more impactor arms and to cause the one or more impactor arms to deform.

Described here are devices and methods for forming shock waves. The devices may comprise an axially extending elongate member. A first electrode pair may comprise a first electrode and a second electrode. The first electrode pair may be provided on the elongate member and positioned within a conductive fluid. A controller may be coupled to the first electrode pair. The controller may be configured to deliver a series of individual pulses to the first electrode pair, where each pulse creates a shock wave. The controller may cause current to flow through the electrode pair in a first direction for some of the pulses in the series and in a second direction opposite the first direction for the remaining pulses in the series.

A delivery system and method for delivering a prosthetic heart valve to the aortic valve annulus via a transaortic approach. The system includes a balloon catheter for delivering a balloon-expandable prosthetic heart valve through an introducer from an approach from outside the patient, through a minimally-invasive opening in the chest cavity through an incision in the aorta, and into the aorta and aortic annulus. The balloon catheter includes a flexible, tapered tip just distal of the balloon to facilitate positioning of the prosthetic heart valve in the proper orientation within the aortic annulus. The prosthetic heart valve may be installed over the existing calcified leaflets, and a pre-dilation valvuloplasty procedure may also be utilized.

A device and method for clot disruption in deep venous thrombosis is disclosed herein. The present technology is directed toward a device for clot maceration that includes a longitudinal member, in the form of a catheter, containing radially arrayed elements which, when positioned within a clot, are moved longitudinally, bidirectionally, and rotated in order to disrupt and macerate the surrounding clot. This allows the fragmented clot to be easily removed through a separate device; alternatively this renders the clot significantly more amenable to treatment with fibrinolytic agents given the markedly enhanced surface area of the fragmented clot. The radially arrayed elements may have a variety of forms, with a preferred embodiment containing bristles shaped specifically to engage vein valves in such a way as to cause no damage to them, while simultaneously prompting the clearance of clot from the valve sinuses.

A valvuloplasty system comprises a balloon adapted to be placed adjacent leaflets of a valve. The balloon is inflatable with a liquid. The system further includes a shock wave generator within the balloon that produces shock waves. The shock waves propagate through the liquid and impinge upon the valve to decalcify and open the valve.

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.

This transcatheter device for the ablation of calcified tissue at the flaps of an aortic valve, is characterized in that it comprises a flexible body (1) acting as a catheter and having a soft and flexible end piece (2) that engages with a previously inserted wire guide (g) suitable for passing through the flaps of the valve above the part where the calcified tissue needs to be removed, said end piece (2) having at least one cutting system (3) comprising two motorized rotating cutting heads (3a) and (3b) disposed coaxially one above the other, the head (3a) located at the end of the end piece and acting first to remove the calcified tissue, has arrangements suitable for making a rough cut by grinding, while the other head (3b) has arrangements suitable for making a fine cut by grinding, said cutting system being mounted in combination with a vacuum suction means (4), said end piece (2) being provided with an adjustable guide means (5) suitable for engaging with the calcified tissue over the course of the ablation operation performed by the cutting system (3) in combination with a spiral path effect applied to the end piece.

A method of diverting fluid flow from a first vessel including an occlusion to a second vessel includes deploying a prosthesis at least partially in a fistula and making valves in the second vessel incompetent. Making the valves in the second vessel incompetent includes at least one of using a reverse valvulotome to cut the valves, inflating a balloon, expanding a stent, and lining the second vessel with a stent.

A transcatheter device (10) includes a first jaw member (12), a second jaw member (14) and a linkage mechanism (16) coupled to the first and second jaw members (12, 14) for changing a distance between the first and second jaw members (12, 14). At least one of the first and second jaw members (12, 14) includes scoring structure (20) capable of scoring calcifications or tissue or any other anatomical structure, with a direction of a scoring force along a jaw closing axis (25) that extends between surfaces (22, 24) of the first and second jaw members (12, 14), respectively, which face each other. The first jaw member (12) has a cutting element (18) arranged to cut in a cutting direction (27) transverse to the jaw closing axis (25).

A valvuloplasty system comprises a balloon adapted to be placed adjacent leaflets of a valve. The balloon is inflatable with a liquid. The system further includes a shock wave generator within the balloon that produces shock waves. The shock waves propagate through the liquid and impinge upon the valve to decalcify and open the valve.