Abstract: Drug delivery balloons have densely packed crystals of small particle size of the drug thereon. An amorphous drug coating is applied to a balloon surface and annealed to provide the crystals. The balloon surface is nucleated to induce formation of drug crystals in the annealing step to provide the crystals in high density with small size.

Abstract: A medical device having a polymer-free outer surface layer comprising a crystalline drug selected from the group consisting of everolimus, tacrolimus, sirolimus, zotarolimus, biolimus, and rapamycin. The device may be produced by a method comprising the steps of providing a medical device; applying a solution of the drug to said portion of the outer surface to form a coating of amorphous drug; and vapor annealing the drug with a solvent vapor to form crystalline drug; wherein a seed layer of a crystalline form of said drug having a maximum particle size of about 10 ?m or less is applied to at least said portion of the outer surface of the device before or after applying the drug solution, but before vapor annealing the amorphous coating.

Abstract: According to an aspect of the present invention, medical devices are provided which include a metallic substrate and a polymeric region disposed over and in contact with the metallic substrate. The polymeric region includes (a) a fluorine-containing polymer that contains at least one type of fluorine-containing monomer selected from a vinylidene fluoride monomer, a hexafluoropropylene monomer, and a combination thereof, and (b) an adhesion promoting copolymer that contains (i) at least one type of first monomer that covalently or non-covalently bonds with the metallic substrate and (ii) at least one type of second monomer selected from acrylate monomers, methacrylate monomers, fluorine-containing monomers, and combinations thereof.

Abstract: A medical device having a polymer-free outer surface layer comprising a crystalline drug selected from the group consisting of everolimus, tacrolimus, sirolimus, zotarolimus, biolimus, and rapamycin. The device may be produced by a method comprising the steps of providing a medical device; applying a solution of the drug to said portion of the outer surface to form a coating of amorphous drug; and vapor annealing the drug with a solvent vapor to form crystalline drug; wherein a seed layer of a crystalline form of said drug having a maximum particle size of about 10 ?m or less is applied to at least said portion of the outer surface of the device before or after applying the drug solution, but before vapor annealing the amorphous coating.

Abstract: According to an aspect of the present invention, surgical meshes are provided which release one or more antimicrobial agents in an amount sufficient to reduce the risk of microbial infection upon implantation of the mesh. Other aspects of the invention pertain to methods of making and using such surgical meshes.

Abstract: Drug delivery balloons are configured with a carrier film of biodegradable polymer. The carrier film includes a drug or has a drug carried thereon. The balloons utilize a film layering system that is designed to separate the carrier film substantially intact from the balloon when expanded, so that the carrier film and the drug are left in place at the tissue site.

Abstract: An implantable metallic medical device having a dual-layered coating with a primer layer having functional groups capable of forming an organo-metallic complex with iron species and a second biocompatible polymer layer. The primer layer is baked onto the metallic medical device functioning as a tie layer between the surface of the medical device and a second biocompatible polymer layer disposed on the primer layer. Baking improves tie layer adhesion and in some cases provides an organo-metallic complex with the metal substrate. The second biocompatible polymer may can a therapeutic agent.

Abstract: In embodiments, a stent comprises a biodegradable polymer functionalized with an adhesion-enhancing amino acid.

Abstract: A renal denervation apparatus includes a treatment element dimensioned for deployment on or within a renal artery of a patient. The treatment element comprises a predefined pattern arranged to complete at least one revolution of the treatment element. The apparatus includes a treatment source. The treatment source and treatment element are configured to cooperatively facilitate communication of an agent from the treatment source to the pattern arrangement of the treatment element. The treatment element is configured to deliver denervation therapy using the agent via the pattern arrangement to one or more regions of the renal artery adjacent the pattern arrangement, such that at least one complete revolution of the renal artery is subjected to the denervation therapy.

Abstract: Drug delivery balloons have densely packed crystals of small particle size of the drug thereon. An amorphous drug coating is applied to a balloon surface and annealed to provide the crystals. The balloon surface is nucleated to induce formation of drug crystals in the annealing step to provide the crystals in high density with small size.

Abstract: When making a medical device having a drug coating thereon, the drug having a plurality of characteristic morphological forms, the manufacturing process is controlled to produce a predetermined ratio of said morphological forms on the device. The process has application to drug coated balloons.

Abstract: According to an aspect of the present invention, medical devices are provided which include a metallic substrate and a polymeric region disposed over and in contact with the metallic substrate. The polymeric region includes (a) a fluorine-containing polymer that contains at least one type of fluorine-containing monomer selected from a vinylidene fluoride monomer, a hexafluoropropylene monomer, and a combination thereof, and (b) an adhesion promoting copolymer that contains (i) at least one type of first monomer that covalently or non-covalently bonds with the metallic substrate and (ii) at least one type of second monomer selected from acrylate monomers, methacrylate monomers, fluorine-containing monomers, and combinations thereof.

Abstract: Disclosed herein are medical devices, such as intravascular stents, for delivering a therapeutic agent to the body tissue of a patient, and a method for making such medical devices. More particularly, the medical devices have a coating that includes a polymer that adheres to the surface of the medical device so that the coating is able to resist damage during loading, deployment and implantation.

Abstract: An ultraviolet curable lubricious coating including at least one lubricious polymer and at least one oxygen-insensitive crosslinkable polymer, methods of making and using the same, and articles coated therewith.

Abstract: Methods and devices for triggering drug release from the outer expandable portion of a balloon catheter are provided. Drug is released from a drug coated balloon catheter via a triggering condition. The triggering condition can be a change in solubility or volume or hydrolysis.

Abstract: An ultraviolet curable lubricious coating including at least one lubricious polymer and at least one oxygen-insensitive crosslinkable polymer, methods of making and using the same, and articles coated therewith.

Abstract: According to an aspect of the invention, implantable or insertable medical devices are provided, which contain one or more composite regions. These composite regions, in turn, contain (a) a polymeric component comprising a vinyl aromatic polymer and (b) a ceramic component comprising a metal or semi-metal oxide.

Abstract: A medical device having multiple layers of a drug-loaded coating. At least one of the layers is more hydrophilic than at least another one of the layers. Also provided is a method for controlling the drug release profile from a coated medical device using multiple layers of modified and/or unmodified copolymers and varying the ratio of modified to unmodified copolymers.

Abstract: Coated medical devices and methods for coating such devices are disclosed. The invention is directed to the use of an anti-adhesion agent in a coating for a medical device. More particularly, the invention is directed to a medical device comprising an anti-adhesion agent that prevents the self-adhesion of different portions of a coating disposed on the surface of the medical device. Additionally, this invention is directed to methods for coating such a medical device.

Abstract: A lubricious coating including at least one ethylenically unsaturated resin and at least one hydrophilic aliphatic polyether polyurethane which does not crosslink with said ethylenically unsaturated resin, and to methods of making and using the same.