Abstract: Prosthetic heart valves may be delivered to a targeted native heart valve site via one or more delivery catheters. In some embodiments, the prosthetic heart valve includes structural features that securely anchor the prosthetic heart valve to the anatomy at the site of the native heart valve. Such structural features can provide robust migration resistance. In addition, the prosthetic heart valves can include structural features that improve sealing between the prosthetic valve and native valve anatomy to mitigate paravalvular leakage. In particular implementations, the prosthetic heart valves occupy a small delivery profile, thereby facilitating a smaller delivery catheter system for advancement to the heart. Some delivery catheter systems can include a curved inner catheter to facilitate deployment of the prosthetic heart valve to a native tricuspid valve site via a superior vena cava or inferior vena cava.

Abstract: Tissue engineering devices and methods employing scaffolds made of absorbable material for use in the human body for tissue genesis and regenerative and cellular medicine including breast reconstruction and cosmetic and aesthetic procedures and supplementing organ function in vivo.

Abstract: The present disclosure provides tissue products produced from adipose tissues, as well as methods for producing such tissue products. The tissue products can include acellular tissue matrices for treatment of a breast.

Abstract: Coaptation assist device for repairing cardiac valves and associated systems and methods are disclosed herein. A coaptation assist device configured in accordance with embodiments of the present technology can include, for example, a fixation member configured to press against cardiac tissue proximate to a native valve annulus, and a stationary coaptation structure extending away from the fixation member. The coaptation structure can include an anterior surface configured to coapt with a first native leaflet during systole and a posterior surface configured to displace at least a portion of a second native leaflet. The device also includes at least one sensor configured to detect parameters associated with at least one of cardiac function and device functionality. The sensors can be pressure sensors configured to detect left atrial pressure and/or left ventricular pressure.

Abstract: A medical device may include an implantable device for treating a body tissue structure. The implantable device may include a wire structure which may include a wave pattern. The wire structure may be elastic so as to provide a pressure around the body tissue structure such that the pressure may change with movement of the body tissue structure.

Abstract: A system and method for loading a suture construct on a soft tissue graft with a graft assembly. The graft assembly includes a frame with an opening extending between a proximal end and a distal end. The frame has a wall with a first side extending to a first edge and a second side extending to a second edge. A lumen extends between the first side and the second side and a plurality of channels extend through the wall between the first edge and the second edge. The graft assembly also includes a transverse hole extending through the proximal end of the frame and a pin removably inserted into the transverse hole.

Abstract: A hybrid medical device that can aid in reconstructive or augmentative surgery of the breast is disclosed. The device can utilize a suitable biological collagen tissue matrix combined with a synthetic material, for example, that can impart a high initial strength to the repair site while permitting proper healing and revitalization of the implanted device.

Abstract: A medical device may include a shaft extending between a proximal end and a distal end. The shaft may include a lumen therein. The medical device may include a handle coupled to the proximal end of the shaft and may include a mode selector. The mode selector may be adapted to transition between a first mode and a second mode of the medical device. The medical device may further include a compressed fluid source. In the first mode, the compressed fluid source may be fluidly coupled with the shaft so as to impart a negative pressure in at least a portion of the lumen. In the second mode, the compressed fluid source may be fluidly coupled with the shaft so as to impart a positive pressure in the at least a portion of the lumen.

Abstract: A system for implanting a repair device onto a native valve of a natural heart to repair the native valve of a patient during a non-open-heart procedure. The system includes a delivery catheter and a valve repair device. The valve repair device is disposed inside the delivery catheter. The valve repair device includes a pair of paddles and a pair of gripping members. The pair of paddles are movable between an open position and a closed position. The pair of paddles and the pair of gripping members are configured to secure the valve repair device to leaflets of the native valve. The pair of paddles are compressed inside the delivery catheter. Each paddle of the pair of paddles is configured to expand upon exiting the delivery catheter to increase the surface area of each paddle.

Abstract: An implantable soft tissue prosthesis device comprising a silicone elastomer-shell filled with silicone gel or liquid, which among the layers that constitute its shell includes a barrier layer formed of a low permeability silicone, which impedes the bleeding or diffusion of the silicone gel from the inside of the implant to its surroundings through the shell. This barrier layer is given a coloration different to the other layers of the shell, making it visible in the finished product. The coloration of the barrier layer gives the fabricator of the implant as well as to medical personnel, the possibility to identify the presence of the barrier layer and its homogeneity, improving the safety of the device.

Abstract: A void occlusion device that includes a scaffold defining a plurality of voids and a reinforcement member is described. The scaffold is configured to permit the infiltration of human tissue into the plurality of voids. The reinforcement member extends through at least a portion of the scaffold and is configured to resist compressive forces exerted on the scaffold. Also described are embodiments where the void occlusion device is biocompatible, bioresorbable, elastic, and suitable for radio imaging.

Abstract: A surgical instrument (100) for placement of a movement restriction device (10) for use in a surgical procedure for treating reflux disease in a patient. The instrument comprises a sleeve (113) and a holding device (111) configured to engage the movement restriction device, wherein the holding device is configured to be placed within the sleeve and be displaceable in relation to the sleeve. The instrument further comprises a first handling portion (101) connected to the sleeve, and a second handling portion (102) connected to the holding device. The handling of at least one of the first and second handling portion creates relative displacement of the holding device in relation to the sleeve, which disengages the holding device from the movement restriction device for performing the placement of the movement restriction device.

Abstract: This invention relates, e.g., to a Myocyte-based Flow Assist Device (MFAD) for treating a subject in need of increased flow of a biological fluid, such as venous blood or lymph, comprising a sheath which comprises rhythmically contracting myocytes.

Abstract: This invention provides a method for determining breast implant geometric properties, engineering stresses, engineering strains and engineering moduli; directly and quickly, using a load frame apparatus. More generally the invention provides a method for determining geometric properties and engineering mechanical properties of any elastomeric device, using a load frame apparatus. Engineering stress and engineering strain properties of breast implants are critical to their safety and durability. The geometric properties of breast implants undergoing compression also relates to the shape stability of breast implants, which may also be related to clinical outcomes such as capsular contracture and other untoward outcomes involving a breast capsule, such as Anaplastic Large Cell Lymphoma (ALCL), double capsule formation, seroma formation and associated breast implant illness (BII).

Abstract: A heart valve includes a valve body made of a flexible material such as pericardium. The valve body is made of two layers of material, an outer layer, and an inner layer that defines a plurality of leaflets. The leaflets of the inner layer are attached to the outer layer. In some embodiments the valve body is made by cutting a single piece of flat source tissue, folding the cut tissue and forming it into a tubular pattern having the inner and outer layers. The multi-layer valve body can be mounted on a stent for delivery within a patient's heart.

Abstract: Packaging for a breast implant, the packaging comprising a lid and a cavity, wherein one of the lid or the cavity is configured to provide direct delivery of the breast implant from the packaging to a surgical pocket. A method for the direct delivery of a breast implant from breast implant packaging to a surgical pocket, the method comprising the steps of: a. ensuring that a delivery device present in a lid or a cavity of the packaging is in a delivery position; b. forming an aperture in the delivery device, thereby opening the packaging; c. transferring the breast implant to the delivery device; d. positioning the delivery device in contact with the surgical pocket; and e. delivering the breast implant to the surgical pocket.

Abstract: The embodiments disclosed herein relate to a ureteral stent having two stent bodies and a tether. The stent can minimize or prevent migration of the device out of the bladder of the patient while also reducing patient discomfort associated with such stents.

Abstract: Apparatus for treating blood flow regurgitation through a native heart valve includes a selective occlusion device sized and configured to be implanted in the native heart valve and selectively operating with at least one of the first or second native leaflets to allow blood flow through the native heart valve when the heart cycle is in diastole and reduce blood flow regurgitation through the native heart valve when the heart cycle is in systole. A clip structure is coupled with the selective occlusion device. The clip structure is configured to be affixed to a margin of at least one of the first or second native leaflets to secure the selective occlusion device to the native heart valve.

Abstract: Prosthetic heart valves and methods of implantation thereof are disclosed herein. In embodiments, a prosthetic heart valve includes a self-expandable frame configured to support of valve member and comprising a plurality of interconnected strut members forming a mesh structure. An inflow end and outflow end portions of the mesh structure respectively define an inflow terminal end and an outflow terminal end of the frame. A portion of the frame tapers inwardly from the inflow terminal end to form a reduced diameter section. In implementations, the frame increases in diameter from the reduced diameter section to an intermediate section. In implementations, the valve member is secured to the frame at the inflow end portion. In implementations, the frame further comprises a plurality of retaining arms that extend from the outflow terminal end and are configured to engage with a valve retaining mechanism of a delivery apparatus.

Abstract: Apparatus and methods are described herein for use in the delivery and deployment of a prosthetic mitral valve into a heart. In some embodiments, an apparatus includes a catheter assembly, a valve holding tube and a handle assembly. The valve holding tube is releasably couplable to a proximal end portion of the catheter assembly and to a distal end portion of the handle assembly. The handle assembly includes a housing and a delivery rod. The delivery rod is configured to be actuated to move distally relative to the housing to move a prosthetic heart valve disposed within the valve holding tube out of the valve holding tube and distally within a lumen of the elongate sheath of the catheter assembly. The catheter assembly is configured to be actuated to move proximally relative to the housing such that the prosthetic valve is disposed outside of the lumen of the elongate sheath.