Abstract: According to the invention there is provided inter alia a medical device for delivering a therapeutic agent to a tissue, the device having a solid surfactant-free particulate coating layer applied to a surface of the device, the coating layer comprising a therapeutic agent and at least one non-polymeric organic additive which is hydrolytically stable; wherein at least a proportion of the particulate coating layer comprising the therapeutic agent and the at least one organic additive melts as a single phase at a lower temperature than the melting point of the therapeutic agent and the at least one organic additive when in pure form; wherein the therapeutic agent is paclitaxel; and wherein the therapeutic agent, when formulated in the coating layer, is stable to sterilization.

Abstract: The present disclosure is directed to a class of fluorinated copolymers, such as PTFE copolymers, that can be dissolved in low toxicity solvents, such as Class III Solvents, and that enable the creation of stable water-in-solvent emulsions comprising the fluorinated copolymers dissolved in a low toxicity solvents and a hydrophilic agent (e.g., a therapeutic agent) dissolved in an aqueous solvent, such as water or saline.

Abstract: The present disclosure is directed to injectable formulations that include biodegradable polymers based on trimethylene carbonate (TMC) with mole fractions of polylactic acid (PLA) and/or polyglycolic acid (PGA) that are used to deliver a bioactive agent to a targeted site. Excipients such as polyethylene glycol (PEG) may be added to the formulations to reduce the injection force and/or to modulate the release of the bioactive agent. Suitable biodegradable polymers for use in the injectable formulations include D,L-PLA:TMC, D-PLA:TMC, L-PLA:TMC, TMC:PLA:PGA and variations thereof. Additionally, copolymers of TMC and PLA and terpolymers of TMC:PLA:PGA may be formed into nanoparticles and delivered to the target site with an injectable crosslinkable polyethylene glycol system. In at least one embodiment, the injectable formulations are used to treat ocular diseases.

Abstract: The present disclosure is directed to a class of fluorinated copolymers, such as PTFE copolymers, that can be dissolved in low toxicity solvents, such as Class III Solvents, and that enable the creation of stable water-in-solvent emulsions comprising the fluorinated copolymers dissolved in a low toxicity solvents and a hydrophilic agent (e.g., a therapeutic agent) dissolved in an aqueous solvent, such as water or saline.

Abstract: A denervation formulation including a denervation drug incorporated into a sustained-release matrix. The sustained-release matrix may include a polycarbonate and a fluoropolymer. The sustained-release matrix may form a plurality of particles to encapsulate the denervation drug. The denervation formulation may be delivered to a patients autonomic neural tissue, including but not limited to a renal sympathetic nerve, a carotid nerve, a pulmonary nerve, and/or a cardiac sympathetic nerve. Upon release, the denervation drug may ablate the patients autonomic neural tissue for treatment of cardiac disease, including but not limited to hypertension, heart failure, and/or atrial and ventricular tachycardia.

Abstract: According to the invention there is provided inter alia a medical device for delivering a paclitaxel to a tissue, the device the device having a coating layer applied to a surface of the device, the coating layer comprising components i), ii) and iii), wherein component i) is a therapeutic agent which is paclitaxel; and component ii) is urea or a pharmaceutically acceptable salt thereof, or a urea derivative or a pharmaceutically acceptable salt thereof; and component iii) is succinic acid, glutaric acid or caffeine, or a pharmaceutically acceptable salt of any one thereof.

Abstract: The present disclosure relates generally to stabilized medical devices having immobilized biologically active entities necessary for sterilization. The present disclosure provides a substrate (200) that is at least partially electrically conductive, and a stabilized enzyme layer (220) disposed over at least a portion of a surface of the substrate. The stabilized enzyme layer (220) may include at least one biologically active sensing component (240), such as glucose oxidase in the case of glucose sensors, and at least one stabilizing component (260) non-covalently combined with the biologically active sensing component (240). The present disclosure further provides the biologically active sensing component (240) having a biological activity detection level from about 25 U/cm3 to about 1,000,000 11/ cm3 of the substrate following ethylene oxide sterilization of the biologically active sensing component.

Abstract: The present disclosure is directed toward composite materials comprising high aspect ratio habits of drug crystals which can be partially or fully extending into a substrate, and additionally, can be projecting from a substrate at an angle of about 20° to about 90°. The present disclosure is directed toward medical devices, such as medical balloons, comprising said composite and methods of using and making the same. The described composite can be used for the local treatment of vascular disease. The present disclosure is also directed toward paclitaxel crystals with a hollow acicular habit.

Abstract: The present disclosure is directed toward composite materials comprising high aspect ratio habits of drug crystals which can be partially or fully extending into a substrate, and additionally, can be projecting from a substrate at an angle of about 20° to about 90°. The present disclosure is directed toward medical devices, such as medical balloons, comprising said composite and methods of using and making the same. The described composite can be used for the local treatment of vascular disease. The present disclosure is also directed toward paclitaxel crystals with a hollow acicular habit.

Abstract: The present disclosure is directed to a class of fluorinated copolymers, such as PTFE copolymers, that can be dissolved in low toxicity solvents, such as Class III Solvents, and that enable the creation of stable water-in-solvent emulsions comprising the fluorinated copolymers dissolved in a low toxicity solvents and a hydrophilic agent (e.g., a therapeutic agent) dissolved in an aqueous solvent, such as water or saline.

Abstract: According to the invention there is provided inter alia a medical device for delivering a paclitaxel to a tissue, the device the device having a coating layer applied to a surface of the device, the coating layer comprising components i), ii) and iii), wherein component i) is a therapeutic agent which is paclitaxel; and component ii) is urea or a pharmaceutically acceptable salt thereof, or a urea derivative or a pharmaceutically acceptable salt thereof; and component iii) is succinic acid, glutaric acid or caffeine, or a pharmaceutically acceptable salt of any one thereof.

Abstract: According to the invention there is provided inter alia a medical device for delivering a paclitaxel to a tissue, the device the device having a coating layer applied to a surface of the device, the coating layer comprising components i), ii) and iii), wherein component i) is a therapeutic agent which is paclitaxel; and component ii) is urea or a pharmaceutically acceptable salt thereof, or a urea derivative or a pharmaceutically acceptable salt thereof; and component iii) is succinic acid, glutaric acid or caffeine, or a pharmaceutically acceptable salt of any one thereof.

Abstract: The present invention relates to articles and methods of treating vascular conditions with a thixotropic, turbid, bioactive agent-containing gel material capable of being essentially removed from an implantation site upon re-establishment of fluid flow at the implantation site.

Abstract: The present disclosure is directed to a class of fluorinated copolymers, such as PTFE copolymers, that can be dissolved in low toxicity solvents, such as Class III Solvents, and that enable the creation of stable water-in-solvent emulsions comprising the fluorinated copolymers dissolved in a low toxicity solvents and a hydrophilic agent (e.g., a therapeutic agent) dissolved in an aqueous solvent, such as water or saline.

Abstract: The present invention relates to articles and methods of treating vascular conditions with a thixotropic, turbid, bioactive agent-containing gel material capable of being essentially removed from an implantation site upon re-establishment of fluid flow at the implantation site.

Abstract: The invention is directed to delivery medical devices that enable consistent “on-demand” delivery of therapeutic agents to a vessel. The medical device of the current invention comprises retractable sheath comprising neckable elements. The medical device of the current invention comprises an expandable member, a hydrophilic coating comprising at least one therapeutic agent about the expandable member or structural layer and a retractable outer sheath with a selectively permeable microstructure. The design and methods disclosed herein ensures that therapeutic agent delivery occurs essentially only during retraction of the outer sheath, minimizing coating and/or therapeutic agent loss to the bloodstream and providing controlled delivery to the treatment site.

Abstract: The present disclosure is directed to a class of fluorinated copolymers, such as PTFE copolymers, that can be dissolved in low toxicity solvents, such as Class III Solvents, and that enable the creation of stable water-in-solvent emulsions comprising the fluorinated copolymers dissolved in a low toxicity solvents and a hydrophilic agent (e.g., a therapeutic agent) dissolved in an aqueous solvent, such as water or saline.

Abstract: The present disclosure is directed to a class of fluorinated copolymers, such as PTFE copolymers, that can be dissolved in low toxicity solvents, such as Class III Solvents, and that enable the creation of stable water-in-solvent emulsions comprising the fluorinated copolymers dissolved in a low toxicity solvents and a hydrophilic agent (e.g., a therapeutic agent) dissolved in an aqueous solvent, such as water or saline.

Abstract: The present disclosure is directed to injectable formulations that include biodegradable polymers based on trimethylene carbonate (TMC) with mole fractions of polylactic acid (PLA) and/or polyglycolic acid (PGA) that are used to deliver a bioactive agent to a targeted site. Excipients such as polyethylene glycol (PEG) may be added to the formulations to reduce the injection force and/or to modulate the release of the bioactive agent. Suitable biodegradable polymers for use in the injectable formulations include D,L-PLA:TMC, D-PLA:TMC, L-PLA:TMC, TMC:PLA:PGA and variations thereof. Additionally, copolymers of TMC and PLA and terpolymers of TMC:PLA:PGA may be formed into nanoparticles and delivered to the target site with an injectable crosslinkable polyethylene glycol system. In at least one embodiment, the injectable formulations are used to treat ocular diseases.

Abstract: The present invention relates to materials having therapeutic compositions releasably contained within the materials. The materials are configured to release therapeutic compositions at a desired rate. The present invention also relates to devices incorporating the materials.