Abstract: An organ perfusion and preservation system for use in preserving an organ from a donor, may include a fluid reservoir, a heat exchanger in fluid communication with the fluid reservoir and configured to selectively raise and lower a temperature of a perfusion fluid, an oxygenator configured to oxygenate the perfusion fluid, an inflow pump in fluid communication with the fluid reservoir and the oxygenator, a fluid inflow line configured to transport perfusion fluid from the oxygenator to the organ, a fluid outflow line configured to transport perfusion fluid away from the organ and back to the reservoir, an outflow pump in fluid communication with the fluid outflow line and the fluid reservoir, and a controller operatively connected to the inflow pump, the outflow pump, and the heat exchanger, wherein the controller is configured to select parameters to reversibly heat and reversibly cool the organ.

Abstract: A color-coded bioprosthetic valve system having a valve with an annular sewing ring, and a valve holder system with a holder sutured to the ring of the valve, a post operatively connected to the holder, and an adapter sutured to the post and having a color associated with the valve model and/or size. For example, the adapter may be blue to indicate that the valve of the system is a mitral valve of a particular type and/or size. The system may also include a flex handle that is configured to engage with the adapter. The handle has a color associated with the adapter such that a user is able to visually determine that the handle color matches the valve model. For example, the handle may have a grip that is colored blue to match the blue color of the adapter. Accordingly, the color-coded system enables users to confirm easily that the correct accessories such as the sizer or flex handle are being used with the correct valve.

Abstract: Systems and methods can include wearable, non-invasive ultrasound modalities for treating a variety of medical conditions, including but not limited to peripheral vascular disease. The modality could be therapeutic ultrasound (TUS), and be configured to promote angiogenesis within a patient via stimulation of cavitation and shear stress, among other mechanisms.

Abstract: The present disclosure concerns embodiments of implantable prosthetic devices, and in particular, implantable prosthetic valves, and methods for making such devices. In one aspect, a prosthetic device includes encapsulating layers that extend over a fabric layer and secure the fabric layer to another component of the device. In particular embodiments, the prosthetic device comprises a prosthetic heart valve, and can be configured to be implanted in any of the native heart valves. In addition, the prosthetic heart valve can be, for example, a transcatheter heart valve, a surgical heart valve, or a minimally-invasive heart valve.

Abstract: This disclosure relates to a heart valve with improved functionality and durability.

Abstract: Methods for the conditioning of bioprosthetic material employ bovine pericardial membrane. A laser directed at the fibrous surface of the membrane and moved relative thereto reduces the thickness of the membrane to a specific uniform thickness and smooths the surface. The wavelength, power and pulse rate of the laser are selected which will smooth the fibrous surface as well as ablate the surface to the appropriate thickness. Alternatively, a dermatome is used to remove a layer of material from the fibrous surface of the membrane. Thinning may also employ compression. Stepwise compression with cross-linking to stabilize the membrane is used to avoid damaging the membrane through inelastic compression. Rather, the membrane is bound in the elastic compressed state through addition cross-linking. The foregoing several thinning techniques may be employed together to achieve strong thin membranes.

Abstract: Methods for the conditioning of bioprosthetic material employ bovine pericardial membrane. A laser directed at the fibrous surface of the membrane and moved relative thereto reduces the thickness of the membrane to a specific uniform thickness and smoothes the surface. The wavelength, power and pulse rate of the laser are selected which will smooth the fibrous surface as well as ablate the surface to the appropriate thickness. Alternatively, a dermatome is used to remove a layer of material from the fibrous surface of the membrane. Thinning may also employ compression. Stepwise compression with cross-linking to stabilize the membrane is used to avoid damaging the membrane through inelastic compression. Rather, the membrane is bound in the elastic compressed state through addition cross-linking. The foregoing several thinning techniques may be employed together to achieve strong thin membranes.

Abstract: The disclosure relates to a heart valve with improved functionality and durability.

Abstract: An annuloplasty repair segment for heart valve annulus repair and a method for forming. A multi-stranded cable replaces solid core wire for both the tricuspid and mitral valves which allows for greater deployment flexibility for minimally-invasive surgical (MIS) implant, while still maintaining the required strength and similar tensile properties of solid-core wire. The particular shape of the annuloplasty ring is fixed using a heat setting process including heating the flexible core member to a temperature higher than 500° C. and holding it in a desired heat-set saddle shape for a period of time. The core is then rapidly cooled to impart physical properties such that the flexible core member can be straightened, during implantation, to fit through a tubular access device and regain the heat-set saddle shape after exiting the access device and, when attached to the native heart valve, the flexible core member is strong enough to remodel the native heart valve.

Abstract: Methods of delivering and using an annuloplasty ring to reshape a valve annulus are disclosed. The methods include obtaining an annuloplasty ring having an elastic inner core member. The elastic inner core member can be defined by a multi-stranded braided cable. The inner core member has an unstressed closed or open ring shape and a first elastic modulus that enables the core member to be compressed from the unstressed ring shape into a stressed narrow shape and enables the annuloplasty ring to reshape a native heart valve annulus. The methods can include converting the annuloplasty ring from the unstressed ring shape into the stressed narrow shape, passing the annuloplasty ring through an access tube positioned with a distal tip adjacent a native valve annulus, and expelling the annuloplasty ring from the distal tip of the access tube so that it self-converts back towards the unstressed ring shape.

Abstract: An annuloplasty repair segment for heart valve annulus repair and a method for forming. A multi-stranded cable replaces solid core wire for both the tricuspid and mitral valves which allows for greater deployment flexibility for minimally-invasive surgical (MIS) implant, while still maintaining the required strength and similar tensile properties of solid-core wire. The particular shape of the annuloplasty ring is fixed using a heat setting process including heating the flexible core member to a temperature higher than 500° C. and holding it in a desired heat-set saddle shape for a period of time. The core is then rapidly cooled to impart physical properties such that the flexible core member can be straightened, during implantation, to fit through a tubular access device and regain the heat-set saddle shape after exiting the access device and, when attached to the native heart valve, the flexible core member is strong enough to remodel the native heart valve.

Abstract: Methods of delivering and using an annuloplasty ring to reshape a valve annulus are disclosed. The methods include obtaining an annuloplasty ring having an elastic inner core member. The elastic inner core member can be defined by a multi-stranded braided cable. The inner core member has an unstressed closed or open ring shape and a first elastic modulus that enables the core member to be compressed from the unstressed ring shape into a stressed narrow shape and enables the annuloplasty ring to reshape a native heart valve annulus. The methods can include converting the annuloplasty ring from the unstressed ring shape into the stressed narrow shape, passing the annuloplasty ring through an access tube positioned with a distal tip adjacent a native valve annulus, and expelling the annuloplasty ring from the distal tip of the access tube so that it self-converts back towards the unstressed ring shape.

Abstract: Devices and related methods of use are provided for improving heart function. In one embodiment of the present disclosure, a device includes a ring-like structure configured to be secured to a heart valve; at least one elongate member extending from the ring-like structure, wherein an end of the elongate member is configured to be secured to heart geometry other than a heart valve; and an adjustment mechanism for simultaneously altering a dimension of the ring-like structure and a length of the elongate member.

Abstract: The present disclosure concerns embodiments of implantable prosthetic devices, and in particular, implantable prosthetic valves, and methods for making such devices. In one aspect, a prosthetic device includes encapsulating layers that extend over a fabric layer and secure the fabric layer to another component of the device. In particular embodiments, the prosthetic device comprises a prosthetic heart valve, and can be configured to be implanted in any of the native heart valves. In addition, the prosthetic heart valve can be, for example, a transcatheter heart valve, a surgical heart valve, or a minimally-invasive heart valve.

Abstract: Devices and related methods of use are provided for improving heart function. In one embodiment of the present disclosure, a device includes a ring-like structure configured to be secured to a heart valve; at least one elongate member extending from the ring-like structure, wherein an end of the elongate member is configured to be secured to heart geometry other than a heart valve; and an adjustment mechanism for simultaneously altering a dimension of the ring-like structure and a length of the elongate member.

Abstract: A color-coded bioprosthetic valve system having a valve with an annular sewing ring, and a valve holder system with a holder sutured to the ring of the valve, a post operatively connected to the holder, and an adapter sutured to the post and having a color associated with the valve model and/or size. For example, the adapter may be blue to indicate that the valve of the system is a mitral valve of a particular type and/or size. The system may also include a flex handle that is configured to engage with the adapter. The handle has a color associated with the adapter such that a user is able to visually determine that the handle color matches the valve model. For example, the handle may have a grip that is colored blue to match the blue color of the adapter. Accordingly, the color-coded system enables users to confirm easily that the correct accessories such as the sizer or flex handle are being used with the correct valve.

Abstract: The present disclosure concerns embodiments of implantable prosthetic devices, and in particular, implantable prosthetic valves, and methods for making such devices. In one aspect, a prosthetic device includes encapsulating layers that extend over a fabric layer and secure the fabric layer to another component of the device. In particular embodiments, the prosthetic device comprises a prosthetic heart valve, and can be configured to be implanted in any of the native heart valves. In addition, the prosthetic heart valve can be, for example, a transcatheter heart valve, a surgical heart valve, or a minimally-invasive heart valve.

Abstract: An annuloplasty repair segment for heart valve annulus repair. In one embodiment a multi-stranded cable replaces solid core wire for both the tricuspid and mitral valves. Cable allows for greater deployment flexibility for minimally-invasive surgical (MIS) implant, while still maintaining the required strength and similar tensile properties of solid-core wire. In addition, selective placement of point-welds or other such control points locally control other parameters such as the amount and direction of displacement as the ring undergoes external loading. Cable with well-placed control points result in a MIS annuloplasty ring with sufficient flexibility in the x-y plane to allow a surgeon to squeeze the ring into a small incision, such as for example 1 cm×1 cm, while maintaining structural rigidity under forces exerted on the implanted ring by the cardiac cycle and allowing for asymmetrical deflection to be designed into the product.

Abstract: The disclosure relates to a heart valve with improved functionality and durability.

Abstract: A color-coded bioprosthetic valve system having a valve with an annular sewing ring, and a valve holder system with a holder sutured to the ring of the valve, a post operatively connected to the holder, and an adapter sutured to the post and having a color associated with the valve model and/or size. For example, the adapter may be blue to indicate that the valve of the system is a mitral valve of a particular type and/or size. The system may also include a flex handle that is configured to engage with the adapter. The handle has a color associated with the adapter such that a user is able to visually determine that the handle color matches the valve model. For example, the handle may have a grip that is colored blue to match the blue color of the adapter. Accordingly, the color-coded system enables users to confirm easily that the correct accessories such as the sizer or flex handle are being used with the correct valve.