Evalve, Inc.

An implant removal device having an elongate body having a proximal end and a distal end, the elongate body being resiliently flexible and configured to transmit torque from the proximal end to the distal end with a predetermined turning ratio, and a capture structure extending distally from the distal end and having a capture region, the capture structure being configured to selectively center a deployed implant in relation to a longitudinal axis of the elongate body and the capture region to aid with capture and subsequent removal.

An implant removal device having an elongate body having a proximal end and a distal end, the elongate body being resiliently flexible and configured to transmit torque from the proximal end to the distal end with a predetermined turning ratio, and a capturing structure extending distally from the distal end and having a capture region, the capturing structure being configured to selectively center a deployed implant in relation to a longitudinal axis of the elongate body and the capture region to aid with capture and subsequent removal.

System for fixation of native leaflets of a heart valve including an implantable fixation device including a center portion defining a longitudinal axis. The implantable fixation device further includes a first distal assembly having a first distal strut pivotally-coupled with the center portion and a first distal element pivotally-coupled with the first distal strut. The first distal assembly is configured to move between a closed position and an extended position. The implantable fixation device further includes a second distal assembly having a second distal strut pivotally-coupled with the center portion and a second distal element pivotally-coupled with the second distal strut. The second distal assembly is configured to move between a closed position and an extended position. The implantable fixation device further includes a locking mechanism configured to lock the first distal assembly and second distal assembly in a selected locked position between the closed position and the extended position.

Devices, systems and methods are provided for stabilizing and grasping tissues such as valve leaflets, assessing the grasp of these tissues, approximating and fixating the tissues, and assessing the fixation of the tissues to treat cardiac valve regurgitation, particularly mitral valve regurgitation.

Devices, systems and methods for removal of a mitral valve clip and subsequent delivery of a mitral valve implantation in a mitral valve replacement procedure. A modular port accessory device having a distal connector configured to be compatible with corresponding connectors on an existing therapeutic device, wherein the port accessory can be selectively attached to a proximal end portion connector of a proximal end portion of a catheter assembly of an existing therapeutic device. The catheter assembly is introduced to a target site within the patient's anatomy, and remains in place throughout a multistep therapeutic procedure for use with other therapeutic devices, all while allowing hemostasis to be controlled during use ad interchange of multiple therapeutic devices.

A stabilizer system for supporting a medical device includes a platform and a stabilizer body positioned on the platform and being slidably translatable about the platform. The platform includes a translation actuator configured to engage with a receiving member of the stabilizer body. Actuation of the translation actuator passes a force to the receiving member of the stabilizer body and causes the stabilizer body to translate relative to the platform. The stabilizer body includes a base and one or more support wings extending from the base to support a medical device. A straddle actuator is coupled to a support wing and is configured to engage with the medical device. Actuation of the straddle actuator passes a force to the medical device and causes at least a portion of the medical device to translate relative to the stabilizer body.

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.

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.

An integrated imaging and device deployment platform and method may include a catheter, at least one imaging unit, at least one deployment unit, and at least one device configured to be deployed by the at least one deployment unit. The integrated imaging and device deployment platform facilitates improved navigation and deployment of a therapeutic or medical device by providing the at least one imaging unit proximate the deployment unit. Information generated from the at least one imaging unit may be utilized with additional imaging modalities to provide improved imaging and delivery of devices while reducing use of X-ray radiation and contrast injection.

Methods, devices, and systems are provided for performing endovascular repair of atrioventricular and other cardiac valves in the heart. A delivery device for staged deployment of an implantable device to a target area. The delivery device includes a deployment handle and one or more lock lines extending from the deployment handle through the catheter to the implantable device, the one or more lock lines being configured to engage with the implantable device to allow locking of the implantable device.