Abstract: A prosthetic mitral valve includes an anchor assembly, a strut frame, and a plurality of replacement leaflets secured to the annular strut frame. The anchor assembly includes a ventricular anchor, an atrial anchor, and a central portion therebetween. The ventricular anchor and the atrial anchor are configured to flare radially outwards relative to the central portion. The annular strut frame is disposed radially within the anchor assembly and is attached to the anchor assembly. The central portion is configured to align with a native valve orifice and the ventricular anchor and the atrial anchor are configured to compress native cardiac tissue therebetween.

Abstract: Prosthetic mitral valves and their methods of manufacture and use.

Abstract: A delivery system for delivering an implantable medical device, such as a prosthetic heart valve, intravascularly to a target site, such as a heart valve annulus in a patient. The system includes a catheter assembly consisting of a plurality of concentrically arranged catheters positioned within an outer sheath and a handle assembly that includes a plurality of controls that selectively translate the catheters relative to one another to deploy the medical device from the outer sheath. An optional inflatable balloon on the catheter assembly helps to visualize the position of the medical device prior to deployment. The delivery system accommodates both the deployment of the medical device as well as re-sheathing should that become necessary.

Abstract: An intravascular device delivery system has an elongated member, a guidewire receiving member, and a distal cap longitudinally fixed to a guidewire receiving member. The distal cap includes an insert having an elongate member, a rim member radially separated from the elongate member, and a wall member supporting the rim member, the wall member being disposed between the rim member and the elongate member.

Abstract: A prosthetic mitral valve includes an anchor assembly, a strut frame, and a plurality of replacement leaflets secured to the annular strut frame. The anchor assembly includes a ventricular anchor, an atrial anchor, and a central portion therebetween. The ventricular anchor and the atrial anchor are configured to flare radially outwards relative to the central portion. The annular strut frame is disposed radially within the anchor assembly and is attached to the anchor assembly. The central portion is configured to align with a native valve orifice and the ventricular anchor and the atrial anchor are configured to compress native cardiac tissue therebetween.

Abstract: A prosthetic heart valve includes a collapsible and expandable outer frame, a collapsible and expandable inner frame, and a prosthetic valve assembly. The outer frame may be configured to engage tissue of a native heart valve, and may have (i) an atrial portion adapted to be positioned on an atrial side of the native heart valve; (ii) a ventricle portion adapted to be positioned on a ventricle side of the native heart valve; and (iii) a narrowed waist portion between the atrial portion and the ventricle portion. The inner frame may be positioned radially inward of the outer frame and may be coupled to the outer frame. A constraining band may extend around a circumference of the inner frame. The prosthetic valve assembly may be coupled to, and positioned radially inward of, the inner frame.

Abstract: The present disclosure provides systems and methods for a replacement mitral valve. The replacement valve may be made of a less rigid material thereby allowing the packed diameter of the replacement valve to be decreased. The less rigid replacement mitral valve may include a ventricular portion and a central portion. The ventricular portion may include a guide channel. A wire may be advanced into the guide channel. The wire in the guide channel may increase the stiffness on the ventricular side of the replacement valve. The increased stiffness may prevent the replacement valve from collapsing through a native valve annulus.

Abstract: A medical device delivery system includes a steering catheter having a flexible tip and a delivery mechanism comprising a coarse control and a fine control. A medical device delivery system includes a steering catheter having a flexible tip and a delivery mechanism comprising a variable torque mechanism.

Abstract: A method of delivering a prosthetic mitral valve includes delivering a distal anchor from a delivery sheath such that the distal anchor self-expands inside a first heart chamber on a first side of the mitral valve annulus, pulling proximally on the distal anchor such that the distal anchor self-aligns within the mitral valve annulus and the distal anchor rests against tissue of the ventricular heart chamber, and delivering a proximal anchor from the delivery sheath to a second heart chamber on a second side of the mitral valve annulus such that the proximal anchor self-expands and moves towards the distal anchor to rest against tissue of the second heart chamber. The self-expansion of the proximal anchor captures tissue of the mitral valve annulus therebetween.

Abstract: A delivery device includes a handle, a central elongate member extending from the handle, a sheath configured to slide over and relative to the central elongate member, a distal tether retainer at a distal end of the central elongate member, a proximal tether restraining mechanism positioned along the central elongate member distal of the handle and proximal of the distal tether retainer, and a plurality of tethers. The tethers are configured to extend from the proximal tether restraining mechanism to the distal tether retainer.

Abstract: A method of delivering a prosthetic mitral valve includes delivering a distal anchor from a delivery sheath such that the distal anchor self-expands inside a first heart chamber on a first side of the mitral valve annulus, pulling proximally on the distal anchor such that the distal anchor self-aligns within the mitral valve annulus and the distal anchor rests against tissue of the ventricular heart chamber, and delivering a proximal anchor from the delivery sheath to a second heart chamber on a second side of the mitral valve annulus such that the proximal anchor self-expands and moves towards the distal anchor to rest against tissue of the second heart chamber. The self-expansion of the proximal anchor captures tissue of the mitral valve annulus therebetween.

Abstract: A loading device configured to radially collapse an expandable medical implant may include an operating handle having an opening therein extending along a longitudinal axis, a native sheath coupled to the operating handle and partially extending into the opening, such that the native sheath is configured to translate relative to the operating handle parallel to the longitudinal axis, a removable sheath removably coupled to the native sheath, an actuation rod extending parallel to the longitudinal axis at least partially through the opening, a lumen of the native sheath, and a lumen of the removable sheath, a distal end of the actuation rod being configured to be removably coupled to the expandable medical implant, and a first control element movable relative to the operating handle and coupled to the native sheath, the first control element being configured to translate the native sheath and the removable sheath relative to the operating handle.

Abstract: A delivery device includes a handle, a central elongate member extending from the handle, a sheath configured to slide over and relative to the central elongate member, a distal tether retainer at a distal end of the central elongate member, a proximal tether restraining mechanism positioned along the central elongate member distal of the handle and proximal of the distal tether retainer, and a plurality of tethers. The tethers are configured to extend from the proximal tether restraining mechanism to the distal tether retainer.

Abstract: A catheter assembly for delivering a medical implant may include an inner shaft around which a compartment is defined, the compartment being adapted to receive the medical implant therein. The catheter assembly may include an outer shaft coaxially surrounding at least a portion of the inner shaft and movable in longitudinal directions relative to the inner shaft. The outer shaft may define a lumen therein, the inner shaft and the outer shaft together defining a space therebetween, the space providing liquid communication between a proximal end of the catheter assembly and the compartment. The catheter assembly may include a distal sheath fixedly connected to the outer shaft, the distal sheath being movable between a closed condition covering the compartment and an open condition uncovering the compartment for deployment of the medical implant. A lubricant containing albumin may be disposed within at least a portion of the space.

Abstract: The present disclosure describes devices, systems, and methods for intravascularly delivering an intravascular device to a targeted cardiac valve. In one aspect, a medical device includes a body and a plurality of positional markers positioned on the body, the plurality of positional markers being defined in part by at least one cutout and having at least one parameter selected such that the plurality of positional markers vibrates, in response to an ultrasound signal, at a resonant frequency.

Abstract: A prosthetic heart valve includes a sealing feature coupled to the inner frame at a coupling point and extending between the coupling point and a point of the outer frame that is radially outward of the coupling point in a direction substantially orthogonal to the longitudinal axis, the sealing feature comprising a plurality of layers.

Abstract: A retrieval catheter for retrieving a partially deployed medical device held at the end of a catheter includes an inner shaft, an intermediate shaft and an outer shaft. The inner shaft engages the catheter in a manner that prevents translation of the inner shaft relative to the catheter. The intermediate shaft is assembled around the inner shaft and includes inner threads that engage with outer threads on the inner shaft such that rotation of the intermediate shaft translates it relative to the inner shaft and the catheter. The outer shaft is assembled around the intermediate shaft and includes a valve cover at its distal end. The valve cover is operatively connected to the intermediate shaft such that translation of the intermediate shaft translates the valve cover. Components of the medical device delivery system are disassembled from the catheter and the retrieval catheter is assembled thereover to retrieve the medical device.

Abstract: A prosthetic heart valve includes collapsible and expandable inner and outer frames. The outer frame engages native heart valve annulus tissue, with an atrial portion, a ventricle portion, and a narrowed waist portion between the two. The inner frame is positioned radially inward of the outer frame. The outer frame includes a plurality of outer coupling arms having a first end coupled to the outer frame and a second free end, and the inner frame includes a plurality of inner coupling arms having a first end coupled to the inner frame and a second free end. A prosthetic valve assembly is disposed within the inner frame. The first end of the inner and outer coupling arms each include two struts. The coupling arms extend toward each other and the second free ends of the coupling arms are coupled to each other to couple the outer frame to the inner frame.

Abstract: The present invention comprises a novel and safer mechanism of deployment using a self-positioning, self-centering, and self-anchoring method. To embody the present invention, a disk-based valve apparatus allowing the repositioning and retrieval of the implantable valve while working on a dysfunctional valve structure is disclosed. The disk-based valve apparatus may comprise one or more disks, either proximal or distal, a valve-housing component and a valve component. The one or more disks may be either proximal or distal, may be either connected to each other or disconnected from each other and may either be symmetrical or have different shapes and dimensions. The disk-based valve apparatus may be self anchoring, such as anchored by pressure from the one or more disk, or may be anchored using any anchoring.

Abstract: A delivery system for delivering a medical device includes a delivery device. The delivery device may include an outer delivery sheath having a compartment at a distal end thereof, the compartment configured to receive the medical device. The delivery device may also include a nosecone catheter positioned radially within the outer delivery sheath, the nosecone catheter having an inner tube configured to receive a guidewire therethrough, and an outer tube, an inflation lumen defined between the inner tube and the outer tube. The delivery device may further include a nosecone that has a length that may be adjusted by pushing an inflation medium into the balloon nosecone or withdrawing the inflation medium from the balloon nosecone via the inflation lumen, the balloon nosecone being reversibly coupled to the nosecone catheter.