Abstract: The present disclosure relates to medical devices, and methods for producing and using the devices. In embodiments, the medical device may be a buttress including a porous substrate possessing a therapeutic layer of a chemotherapeutic agent and optional excipient(s) thereon. By varying the form of chemotherapeutic agents and excipients, the medical devices may be used to treat both the area to which the medical device is attached as well as tissue at a distance therefrom.

Abstract: Provided herein are methods, devices, compositions, and kits for monitoring neuromodulation efficacy based on changes in the level or activity of one or more target biomarkers.

Abstract: Provided herein are methods, devices, compositions, and kits for monitoring neuromodulation efficacy based on changes in the level or activity of one or more target biomarkers. One aspect includes a comparison of baseline and post-modulation levels of one or more biomarkers in bodily fluid that have each been collected from a human subject at a relevant time, and that may be used to assess the neuromodulation efficacy. The post-neuromodulation levels for the one or more biomarkers may be collected from the human subject within about 5 minutes to about 14 days post-neuromodulation.

Abstract: The present disclosure relates to medical devices, and methods for producing and using the devices. In embodiments, the medical device may be a buttress including a porous substrate possessing a therapeutic layer of a chemotherapeutic agent and optional excipient(s) thereon. By varying the form of chemotherapeutic agents and excipients, the medical devices may be used to treat both the area to which the medical device is attached as well as tissue at a distance therefrom.

Abstract: The present disclosure relates to medical devices, and methods for producing and using the devices. In embodiments, the medical device may be a buttress including a porous substrate possessing a therapeutic layer of a chemotherapeutic agent and optional excipient(s) thereon. By varying the form of chemotherapeutic agents and excipients, the medical devices may be used to treat both the area to which the medical device is attached as well as tissue at a distance therefrom.

Abstract: A method of forming an electrospun prosthetic valve includes utilizing a rotatable and angularly adjustable prosthetic valve mold. The prosthetic valve mold is set to a first angle. The prosthetic valve mold is rotated at a first rotational velocity and a first layer of electrospun fibers is deposited on the prosthetic valve mold. The prosthetic valve mold is stopped and a frame is positioned over the first layer. The prosthetic valve mold is set to a second angle. The prosthetic valve mold is rotated at a second velocity and a second layer of electrospun fibers is deposited on an outer surface of the first layer and an outer surface of the frame.

Abstract: Provided herein are methods, devices, compositions, and kits for monitoring neuromodulation efficacy based on changes in the level or activity of one or more target biomarkers.

Abstract: The present disclosure relates to medical devices, and methods for producing and using the devices. In embodiments, the medical device may be a buttress including a porous substrate possessing a therapeutic layer of a chemotherapeutic agent and optional excipient(s) thereon. By varying the form of chemotherapeutic agents and excipients, the medical devices may be used to treat both the area to which the medical device is attached as well as tissue at a distance therefrom.

Abstract: Provided herein are methods, devices, compositions, and kits for monitoring neuromodulation efficacy based on changes in the level or activity of one or more target biomarkers.

Abstract: Methods and apparatus are disclosed for filling a therapeutic substance or drug within a hollow wire that forms a stent. The stent is placed within a chamber housing a fluid drug formulation. During filling, the chamber is maintained at or near the vapor-liquid equilibrium of the solvent of the fluid drug formulation. To fill the stent, a portion of the stent is placed into contact with the fluid drug formulation until a lumenal space defined by the hollow wire is filled with the fluid drug formulation via capillary action. After filling is complete, the stent is retracted such that the stent is no longer in contact with the fluid drug formulation. The solvent vapor pressure within the chamber is reduced to evaporate a solvent of the fluid drug formulation. A wicking means may control transfer of the fluid drug formulation into the stent.

Abstract: Provided herein are methods, devices, compositions, and kits for monitoring neuromodulation efficacy based on changes in the level or activity of one or more target biomarkers.

Abstract: Provided herein are methods, devices, compositions, and kits for monitoring neuromodulation efficacy based on detecting changes in the level or activity of one or more target biomarkers associated with neuromodulation, as well as methods and processes of performing neuromodulation that incorporate monitoring of neuromodulation efficacy based on changes in level or activity of one or more target biomarkers.

Abstract: Methods and apparatus are disclosed for filling a therapeutic substance or drug within a hollow wire that forms a stent. The stent is placed within a chamber housing a fluid drug formulation. During filling, the chamber is maintained at or near the vapor-liquid equilibrium of the solvent of the fluid drug formulation. To fill the stent, a portion of the stent is placed into contact with the fluid drug formulation until a lumenal space defined by the hollow wire is filled with the fluid drug formulation via capillary action. After filling is complete, the stent is retracted such that the stent is no longer in contact with the fluid drug formulation. The solvent vapor pressure within the chamber is reduced to evaporate a solvent of the fluid drug formulation. A wicking means may control transfer of the fluid drug formulation into the stent.

Abstract: Methods and apparatus are disclosed for loading a therapeutic substance or drug within a lumenal space of a hollow wire having a plurality of side openings along a length thereof that forms a hollow drug-eluting stent with a plurality of side drug delivery openings. Loading a drug within the lumenal space of the hollow stent includes a drug filling step, in which the drug is mixed with a solvent or dispersion medium. The lumenal space may be filled with the drug solution or suspension in a reverse fill process and/or a forward fill process. After the drug filling step, a solvent or dispersion medium extracting step is performed to extract the solvent or dispersion medium from within the lumenal space such that only the drug remains within the hollow stent. A stent cleaning step may be performed to an exterior surface of the hollow stent.

Abstract: Provided herein are methods, devices, compositions, and kits for monitoring neuromodulation efficacy based on changes in the level or activity of one or more target biomarkers.

Abstract: Methods and apparatus are disclosed for loading a therapeutic substance or drug within a lumenal space of a hollow wire having a plurality of side openings along a length thereof that forms a hollow drug-eluting stent with a plurality of side drug delivery openings. Loading a drug within the lumenal space of the hollow stent includes a drug filling step, in which the drug is mixed with a solvent or dispersion medium. The lumenal space may be filled with the drug solution or suspension in a reverse fill process and/or a forward fill process. After the drug filling step, a solvent or dispersion medium extracting step is performed to extract the solvent or dispersion medium from within the lumenal space such that only the drug remains within the hollow stent. A stent cleaning step may be performed to an exterior surface of the hollow stent.

Abstract: Methods and apparatus are disclosed for loading a therapeutic substance or drug within a lumenal space of a hollow wire having a plurality of side openings along a length thereof that forms a hollow drug-eluting stent with a plurality of side drug delivery openings. Loading a drug within the lumenal space of the hollow stent includes a drug filling step, in which the drug is mixed with a solvent or dispersion medium. The lumenal space may be filled with the drug solution or suspension in a reverse fill process and/or a forward fill process. After the drug filling step, a solvent or dispersion medium extracting step is performed to extract the solvent or dispersion medium from within the lumenal space such that only the drug remains within the hollow stent. A stent cleaning step may be performed to an exterior surface of the hollow stent.

Abstract: A method of recanalizing a chronic total occlusion (CTO) is disclosed. A catheter with a guidewire slidingly received therein is positioned proximally adjacent to the CTO. An occlusion weakening therapy effective to quickly soften and/or loosen the CTO is delivered to the CTO via the catheter. The occlusion weakening therapy includes at least one enzyme and a chelating agent which are selectively deliverable either together or separately depending on the type of material encountered by the guidewire. According to various methods, the enzyme(s) may be delivered if tissue is encountered, the chelating agent may be delivered if calcification is encountered, and both enzyme(s) and chelating agent(s) may be delivered if a fibrous cap is encountered. The distal end of the guidewire may be advanced into the CTO shortly after delivery of the occlusion weakening therapy and is manipulated through the CTO until the guidewire successfully crosses the CTO.

Abstract: Methods and apparatus are disclosed for loading a therapeutic substance or drug within a lumenal space of a hollow wire having a plurality of side openings along a length thereof that forms a hollow drug-eluting stent with a plurality of side drug delivery openings. Loading a drug within the lumenal space of the hollow stent includes a drug filling step, in which the drug is mixed with a solvent or dispersion medium. The lumenal space may be filled with the drug solution or suspension in a reverse fill process and/or a forward fill process. After the drug filling step, a solvent or dispersion medium extracting step is performed to extract the solvent or dispersion medium from within the lumenal space such that only the drug remains within the hollow stent. A stent cleaning step may be performed to an exterior surface of the hollow stent.

Abstract: Methods and apparatus are disclosed for loading a therapeutic substance or drug within a lumenal space of a hollow wire having a plurality of side openings along a length thereof that forms a hollow drug-eluting stent with a plurality of side drug delivery openings. Loading a drug within the lumenal space of the hollow stent includes a drug filling step, in which the drug is mixed with a solvent or dispersion medium. The lumenal space may be filled with the drug solution or suspension in a reverse fill process and/or a forward fill process. After the drug filling step, a solvent or dispersion medium extracting step is performed to extract the solvent or dispersion medium from within the lumenal space such that only the drug remains within the hollow stent. A stent cleaning step may be performed to an exterior surface of the hollow stent.