Abstract: An implantable electrical lead suitable for left sided cardiac placement, the implantable medical electrical lead having an external blood contacting surface having an external coating including a monolayer of at least one biological agent that promotes endothelialization covalently attached to a polymeric lead surface.

Abstract: A medical device for implantation into vessels or luminal structures within the body is provided, which stimulates positive blood vessel remodeling. The medical device, such as a stent and a synthetic graft, is provided with a coating with a pharmaceutical composition containing a controlled-release matrix and one or more pharmaceutical substances for direct delivery of drugs to surrounding tissues. The coating on the medical device further comprises one or more barrier layers, and a ligand such as a peptide, an antibody or a small molecule for capturing progenitor endothelial cells in the blood contacting surface of the device for restoring an endothelium at the site of injury. In particular, the drug-coated stents are for use, for example, in balloon angioplasty procedures for preventing or inhibiting restenosis.

Abstract: The present invention relates to a method to treat a grafts, implant, scaffold, and constructs, including allografts, xenografts, autografts, and prosthetics comprising collagen, with an inhibitor of collagen cross-links and/or advanced glycation endproducts (AGE), in order to alleviate the mechanical weakness induced by the cross-links. The invention also provides for kits for use in the operating theater during autograft, allograft or xenograft procedures, or for preparing allograft, xenografts or prosthetics that have not been already treated prior to packaging. The kit comprises a first agent or agents that inhibit collagen cross-links and/or advanced glycation endproducts, instructions for use, optionally a wash or rinse agent, and a device for containing the graft and first agent.

Abstract: Methods of tissue passivation are described herein for use in preserving normal tissue architecture, reducing post-surgical inflammation, and reducing or preventing the development of pathogenic collagen bundles and adhesions following surgical procedures. Passivated tissues prepared in accordance with these methods are useful in a variety of therapies including, e.g., cardiac bypass surgery, hemodialysis, etc.

Abstract: The present invention relates to a drug eluting stent for delivering therapeutic agents to a body lumen. The stent includes an expandable substrate configured for implantation in a vessel of a human body and a therapeutic agent composition coated over the stent. The balloon catheter shaft has a resilient unit that helps to transmit a force to the distal end, thereby helping to cross lesions.

Abstract: A stent with at least one severable supporting device and methods of coating using the same are disclosed. The severable supporting device can be an end tube or a tab attached to some portion of the stent by at least one “gate” or attachment. The end tube or tab may be part of the design of the stent when it is originally manufactured, or it may be attached to the stent in a secondary process by a biocompatible glue or solder. The end tube or tab can be used to support a stent during a coating process eliminating the need for a mandrel which would otherwise contact the stent during the coating process.

Abstract: Biocompatible materials for use in vascular applications or for implantation have been engineered, combining human recombinant tropoelastin with other synthetic or natural biomaterials to form protoelastin. The materials can be in the form of elastin films on metal or polymer substrates, laminates of alternating polymer and elastin, blends of polymer and elastin, or elastin crosslinked with or tethered to polymer or metal. These are mechanically stable, elastic, strong and biocompatible (i.e., not thrombogenic and promoting adhesion of cells, especially human endothelial cells), not eliciting a foreign body response. Plasma polymerization of substrate is shown to enhance biocompatibility, especially when used to bind elastin or other protein to the substrate.

Abstract: Provided herein re a composition and a coating or a device (e.g., absorbable stent) that includes a PEGylated hyaluronic acid and a PEGylated non-hyaluronic acid biocompatible polymer and the methods of use thereof.

Abstract: Various embodiments of methods and devices for drying coated stents in an oven are described herein.

Abstract: A stent includes a stent body of a cylindrical configuration having outer and inner surfaces, a first coated layer coating at least the outer surface, and a second coated layer coating substantially completely over the first coated layer. The first coated layer is prepared of a first composition comprising a polymer and a vascular intimal hyperplasia inhibitor (preferably argatroban) of a kind, which does not inhibit proliferation of endothelial cells, the weight compositional ratio of the polymer to the inhibitor being within the range of 8:2 to 3:7. On the other hand, the second coated layer is prepared of a polymer alone or a second composition comprising a polymer and a drug, the weight compositional ratio of the drug to 80% by weight of the polymer being less than 20% by weight.

Abstract: A stent with at least one severable supporting device and methods of coating using the same are disclosed. The severable supporting device can be an end tube or a tab attached to some portion of the stent by at least one “gate” or attachment. The end tube or tab may be part of the design of the stent when it is originally manufactured, or it may be attached to the stent in a secondary process by a biocompatible glue or solder. The end tube or tab can be used to support a stent during a coating process eliminating the need for a mandrel which would otherwise contact the stent during the coating process.

Abstract: Medical devices, such as endoprostheses, and methods of making the devices are disclosed. The medical device can include a metallic film comprising nickel, titanium, and chromium, wherein a ratio of a weight of chromium of the metallic film to a combined weight of nickel, titanium, and chromium of the metallic film is at least 0.001. The metallic film can include a shape memory alloy.

Abstract: Compositions and methods are provided for producing a medical device such as a stent, a stent graft, a synthetic vascular graft, heart valves, coated with a biocompatible matrix which incorporates antibodies, antibody fragments, or small molecules, which recognize, bind to and/or interact with a progenitor cell surface antigen to immobilize the cells at the surface of the device. The coating on the device can also contain a compound or growth factor for promoting the progenitor endothelial cell to accelerate adherence, growth and differentiation of the bound cells into mature and functional endothelial cells on the surface of the device to prevent intimal hyperplasia. Methods for preparing such medical devices, compositions, and methods for treating a mammal with vascular disease such as restenosis, artherosclerosis or other types of vessel obstructions are disclosed.

Abstract: A medical device for implantation into vessels or luminal structures within the body is provided, which stimulates positive blood vessel remodeling. The medical device, such as a stent and a synthetic graft, is coated with a pharmaceutical composition consisting of a controlled-release matrix and one or more pharmaceutical substances for direct delivery of drugs to surrounding tissues. The coating on the medical device further comprises a ligand such as a peptide, an antibody or a small molecule for capturing progenitor endothelial cells in the blood contacting surface of the device for restoring an endothelium at the site of injury. In particular, the drug-coated stents are for use, for example, in balloon angioplasty procedures for preventing or inhibiting restenosis.

Abstract: An endoprosthesis, e.g., a stent (e.g., a drug eluting stent), that includes a porous surface and hollow elements integrated with a coating on the surface and a method of making the same are disclosed.

Abstract: This invention is directed to graft materials for implanting, transplanting, replacing, or repairing a part of a patient and to methods of making the graft materials. The present invention is also directed to stent grafts and endoluminal prostheses formed of the graft materials. More specifically, the present invention is a graft material which includes porous polymeric sheet, extracellular matrix material (ECM) disposed on at least a portion of the porous polymeric sheet and at least one polymer layer disposed on at least a portion of the ECM. The ECM may be in a gel form. The polymeric sheet and the polymer layer may be made from foam material and may comprise a polyurethane urea and a surface modifying agent such as siloxane.

Abstract: Medical devices, and in particular implantable medical devices, may be coated to minimize or substantially eliminate a biological organism's reaction to the introduction of the medical device to the organism. The medical devices may be coated with any number of biocompatible materials. Therapeutic drugs, agents or compounds may be mixed with the biocompatible materials and affixed to at least a portion of the medical device. In addition, various polymer combinations as well as other therapeutic agents may be utilized to control the elution rates of the therapeutic drugs, agents and/or compounds from the implantable medical devices.

Abstract: Provided herein are a method, which comprises implanting in a patient an implantable device comprising a coating that includes a PEGylated hyaluronic acid and a PEGylated non-hyaluronic acid biocompatible polymer and the methods of use thereof.

Abstract: A stent mandrel fixture for supporting a stent during the application of a coating substance is provided. A method supporting a stent during the application of a coating substance is also provided.

Abstract: A mounting assembly for a stent and a method of coating a stent using the assembly are provided.

Abstract: A stent mandrel fixture for supporting a stent during the application of a coating substance is provided.

Abstract: Implantable devices (e.g., stent) having a protein patterning or bioactive patterning for accelerated healing and method of forming and using the same are provided.

Abstract: An endoluminal device comprises a stent and a tubular graft supported by the stent. The graft has a proximal and a distal opening and comprises a synthetic material and a bioremodelable material. The bioremodelable material is disposed on an exterior surface in at least one band adjacent at least one of the proximal and distal openings.

Abstract: Provided herein is a PEA polymer blend and coatings or implantable devices formed therefrom.

Abstract: A stent fixture for supporting a stent during the application of a coating substance is provided.

Abstract: A mounting assembly for a stent and a method of coating a stent using the assembly are provided.

Abstract: A stent mandrel fixture for supporting a stent during the application of a coating substance is provided. A method supporting a stent during the application of a coating substance is also provided.

Abstract: Implantable devices (e.g., stent) having a protein patterning or bioactive patterning for accelerated healing and method of forming and using the same are provided.

Abstract: An implantable member for use in the body is provided herein. This implantable member includes a porous biocompatible substrate; the substrate having at least one surface sealed fluid-tight with self-aggregating protein particles of substantially the same diameter range. The self-aggregated protein particles are formed from a deposited aqueous slurry of the protein particles.

Abstract: The present invention provides intravascular prostheses and methods of production and use. An implantable device for treating a vascular disease or disorder includes an intravascular prosthesis containing an inhibitor of smooth muscle cell proliferation and a growth factor. The device can be coated with a biodegradable drug-eluting polymer that is impregnated with the inhibitor of smooth muscle cell proliferation and the growth factor. The device is useful for treating or preventing a vascular disease or disorder such as restenosis, by simultaneously inhibiting vessel blockage and enhancing recovery of the vessel wall following an intravascular intervention.

Abstract: An apparatus for coating implantable medical devices, such as stents, and a method of coating stents using the apparatus is also disclosed. The apparatus includes a barrier or barriers for isolating an area of the stent on which a composition for coating a stent is applied. Two coating compositions can be applied simultaneously to a stent by separate nozzles on different sides of a barrier. Cross-contamination of the compositions is prevented by the barrier.

Abstract: An endoluminal device comprises a stent and a tubular graft supported by the stent. The graft has a proximal and a distal opening and comprises a synthetic material and a bioremodelable material. The bioremodelable material is disposed on an exterior surface in at least one band adjacent at least one of the proximal and distal openings.

Abstract: This invention provides a stent for implantation in a blood vessel or other tissue, wherein the stent is coated with or contains C3 exoenzyme, a chimeric version thereof or an inhibitor of RhoA. This invention also provides a method for treating or inhibiting the onset of restenosis in a subject which comprises implanting one of the instant stents in the subject's blood vessel.

Abstract: This disclosure covers polymers, some of which are useful in medical device applications. Some of these medical devices are implantable within a mammalian body, such as in a body lumen. The copolymers comprise at least one alcoholic moiety derived from a diol, triol, or polyol. Additionally, the copolymers comprise an acidic moiety, derived from a polycarboxylic acid, and a biobeneficial moiety. Some of these copolymers are biodegradable or bioerodable. Medical devices comprising these polymers and methods of making these polymers are within the scope of this disclosure.

Abstract: An endovascular graft, having both an expandable stent portion and a stent cover portion positioned, the graft itself and/or a stent cover-portion coated with a bioactive agent adapted to promote initial thrombus formation, preferably followed by long term fibrous tissue ingrowth. The endovascular graft prevents endoleaking by promoting a short term hemostatic effect in the perigraft region. This short term effect can, in turn, be used to promote or permit long term fibrous tissue ingrowth. Particularly where the stent cover portion is prepared from a porous material selected from PET and ePTFE, the bioactive agent can include a thrombogenic agent such as collagen covalently attached in the form of a thin, conformal coating on at least the outer surface of the stent cover. An optimal coating of this type is formed by the activation of photoreactive groups.

Abstract: A stent mandrel fixture for supporting a stent during the application of a coating substance is provided. A method supporting a stent during the application of a coating substance is also provided.

Abstract: The present invention relates to artificial vascular grafts, methods for manufacturing and uses for them. The grafts are coated on their lumen with UP50. The grafts comprise an inner surface on which cells genetically altered to express or over-express one or more cell adhesion factors and one or more cell proliferation factors are seeded and cultured.

Abstract: Coatings for implantable medical devices and methods for fabricating the same are disclosed. The coatings include carboxylated acrylates and polycationic peptides, for example R7.

Abstract: A new embolic agent, bioabsorbable polymeric material (BPM) is incorporated to a Guglielmi detachable coil (GDC) to improve long-term anatomic results in the endovascular treatment of intracranial aneurysms. The embolic agent, comprised at least in part of at least one biocompatible and bioabsorbable polymer and growth factors, is carried by hybrid bioactive coils and is used to accelerate histopathologic transformation of unorganized clot into fibrous connective tissue in experimental aneurysms. An endovascular cellular manipulation and inflammatory response are elicited from implantation in a vascular compartment or any intraluminal location. Thrombogenicity of the biocompatible and bioabsorbable polymer is controlled by the composition of the polymer. The coil further is comprised at least in part of a growth factor or more particularly a vascular endothelial growth factor, a basic fibroblast growth factor or other growth factors.

Abstract: A medical device coated with one or more antibodies and one or more layers of a matrix is disclosed. The antibodies or fragments thereof react with an endothelial cell surface antigen. Also disclosed are compositions and methods for producing the medical device. The matrix coating the medical device may be composed of a synthetic material, such as a fullerene, or a naturally occurring material. The fullerenes range from about C60 to about C100. The medical device may be a stent or a synthetic graft. The antibodies promote the adherence of cells captured in vivo on the medical device. The antibodies may be mixed with the matrix or covalently tethered through a linker molecule to the matrix. Following adherence to the medical device, the cells differentiate and proliferate on the medical device. The antibodies may be different types of monoclonal antibodies.

Abstract: A coupling device to connect a stent support fixture to a processing apparatus is provided.

Abstract: A device for supporting a stent is disclosed. The device includes a mandrel and a gear. The gear allows for rotation of the stent during a coating process.

Abstract: One aspect of the present invention provides implantable medical devices that comprise: (a) a device body; and (b) a surface layer attached to at least a portion of the device body, the surface layer comprising: (1) a surface layer body that defines an internal surface attached to the device body, and an external surface; and (2) a multiplicity of blood vessels disposed within the surface layer body, the blood vessels opening onto the external face of the surface layer body. The present invention also provides synthetic biocompatible materials, methods for making synthetic biocompatible materials, and methods for making implantable medical devices.

Abstract: Cardiovascular cell proliferation in a blood vessel subjected to trauma, such as angioplasty, vascular graft, anastomosis, or organ transplant, can be inhibited by contacting the vessel with a polymer consisting of from 6 to about 30 amino acid subunits, where at least 50% of the subunits are arginine, and the polymer contains at least six contiguous arginine subunits. Exemplary polymers for this purpose include arginine homopolymers 7 to 15 subunits in length.

Abstract: A novel biomedical material, which is characterized by coating a genetically engineered CBD-RGD peptide layer on the surface of a biomedical material consisting of PU to improve the attachment of tissue cells, such as fibroblasts, epithelial cells and endothelial cells. A modified artificial vessel is also disclosed, wherein the adherence of endothelial cells is enhanced by coating a genetically engineered CBD-RGD containing peptide layer on the inner surface of the artificial vessels pre-modified by cross-linked gelatin, and the adhering capacity and activation of platelets is reduced.

Abstract: A stent mounting device and a method of coating a stent using the device are provided.

Abstract: A support device for a stent and a method of coating a stent using the device are provided.

Abstract: A crosslinkable macromer system and related methods of preparing the system and using the system in the form of a crosslinked matrix between a tissue site and an implant article such as a tissue implant or on the porous surface of a prosthetic device. The macromer system includes two or more polymer-pendent polymerizable groups and one or more initiator groups (e.g., polymer-pendent initiator groups). The polymerizable groups and the initiator group(s), when polymer-pendent, can be pendent on the same or different polymeric backbones. The macromer system provides advantages over the use of polymerizable macromers and separate, low molecular weight initiators, including advantages with respect to such properties as nontoxicity, efficiency, and solubility. A macromer system of the invention can be used as an interface between the tissue site and implant article in a manner sufficient to permit tissue growth through the crosslinked matrix and between the tissue site and implant.

Abstract: This invention provides compositions and methods for producing a medical device coated with a matrix and an antibody which reacts with an endothelial cell antigen. The matrix coating the medical device may be composed of synthetic material, such as polyurethane, poly-L-lactic acid, cellulose ester or polyethylene glycol. In another embodiment, the matrix is composed of naturally occurring materials, such as collagen, fibrin, elastin, amorphous carbon. In a third embodiment, the matrix may be composed of fullerenes. The fullerenes range from about C60 to about C100. The medical device may be a stent or a synthetic graft. The antibodies promote adherence of endothelial cells on the medical device. The antibodies may be mixed with the matrix or covalently tethered through a linker molecule to the matrix. Following adherence to the medical device, the endothelial cells differentiate and proliferate on the medical device. The antibodies may be different types of monoclonal antibodies.

Abstract: A vascular graft comprised of a tubular polytetrafluoroethylene (ePTFE) sheet. The ePTFE sheet has a substantially uniform coating of bioresorbable gel material on an outer surface. The coating minimizes bleeding through suture holes in the ePTFE sheet and an increase in longitudinal extensibility.