Abstract: Disclosed is an interventional device for delivery of therapeutic agents from an angioplasty balloon and from a prosthesis such as an intraluminal stent. The invention also relates to the method of loading the beneficial agents onto the balloon and the device, as well as the method of delivery of the agents from separate surfaces. The invention also relates to an interventional device having a prosthesis surface that is loaded with a first beneficial agent, and a balloon surface loaded with a second beneficial agent. The invention also relates to a method of loading multiple beneficial agents onto the prosthesis surfaces and the balloon surfaces, and to a method of manufacturing an interventional device for the delivery of a first beneficial agent and a second beneficial agent from separate surfaces.

Abstract: The present invention relates to a medical device or implant made at least in part of a high strength, low modulus metal alloy comprising Niobium, Tantalum, and at least one element selected from the group consisting of Zirconium, Tungsten and Molybdenum. The medical devices according to the present invention provide superior characteristics with regard to biocompatibility, radio-opacity and MRI compatibility.

Abstract: A dilatation balloon is fabricated according to a process that forms cavities and indentations in the balloon and/or catheter sections. A length of tubing is axially elongated and radially expanded in a form to provide the requisite biaxial orientation and strength. Then, an excimer laser or another type of laser or mechanical material removal tool is used to remove the polymeric material, virtually without thermal effects. Cavities in the sleeve sections of the balloon are defined and if desired, indentations in the cone sections are defined. Material removal, particularly near the balloon sleeves enables a thinner, more flexible bonding area between the catheter shaft and the balloon. Further, the indentations along the cone sections enables tighter wrapping of the balloon for a reduced delivery profile. Rigidity near the sleeves is reduced for better maneuverability of the catheter in tortuous passageways.

Abstract: A device and method is disclosed for reducing turbulent blood flow over stent struts of an intravascular stent implanted in, for example, a coronary artery. An abrasive slurry is passed over the struts of an intravascular stent in order to remove a portion of the stent struts to form an airfoil shape. When the stent having airfoil-shaped struts is implanted in an artery, the flow of blood over the airfoil shape will reduce the likelihood of turbulent blood flow and thereby will reduce the likelihood of turbulent blood flow and thereby reduce the likelihood of a buildup in plaque or injury to the vessel wall.

Abstract: The present invention relates to balloon catheters for treating a luminal system of a patient. Specifically, the invention relates to catheters having a flexible membrane positioned at a distal portion of the catheter, the flexible membrane retained in a substantially unexposed conformation prior to deployment. Preferably the flexible membrane is capable of delivering a therapeutic agent to a localized environment when deployed to an exposed conformation.

Abstract: An apparatus and method for electrochemically treating the struts of an intravascular stent is disclosed. An intravascular stent is mounted in a chamber and is electrochemically treated in order to remove a portion of the stent struts in order to form an airfoil shape. The airfoil-shaped stent struts will reduce turbulent blood flow in the vasculature in which the stent is implanted thereby improving clinical outcome.

Abstract: The present invention provides a stent comprising a tubular flexible body having a wall with a web structure that is expandable from a contracted delivery configuration to deployed configuration. The web structure comprises a plurality of neighboring web patterns, where each web patterns is composed of adjoining webs, and the web patterns are interconnected. Each adjoining web comprises a central section interposed between two lateral sections to form concave or convex configurations.

Abstract: A dilatation balloon is fabricated according to a process that forms cavities and indentations in the balloon and/or catheter sections. A length of tubing is axially elongated and radially expanded in a form to provide the requisite biaxial orientation and strength. Then, an excimer laser or another type of laser or mechanical material removal tool is used to remove the polymeric material, virtually without thermal effects. Cavities in the sleeve sections of the balloon are defined and if desired, indentations in the cone sections are defined. Material removal, particularly near the balloon sleeves enables a thinner, more flexible bonding area between the catheter shaft and the balloon. Further, the indentations along the cone sections enables tighter wrapping of the balloon for a reduced delivery profile. Rigidity near the sleeves is reduced for better maneuverability of the catheter in tortuous passageways.

Abstract: Intraluminal scaffold assembly implantable in a body lumen of a patient to manipulate a valve of the lumen is provided. The intraluminal scaffold assembly includes an intraluminal scaffold, an elongated core member coupled with the intraluminal scaffold having a length sufficient to traverse a valve in a body lumen with the intraluminal scaffold positioned proximate the valve. The intraluminal scaffold assembly can further include one or more additional intraluminal scaffolds, a weighted element or an active element that is coupled with the elongated core member. A system including a delivery system and the intraluminal scaffold assembly, as well as methods of delivering the intraluminal scaffold assembly and using the intraluminal scaffold assembly to manipulate a valve in a body lumen, is also provided.

Abstract: Expandable intraluminal scaffold defining a longitudinal axis is provided, wherein the scaffold includes at least two filaments extending from a head portion disposed along the longitudinal axis at a first longitudinal end, each of the at least two filaments including a free end portion at a second longitudinal end opposite the head portion. The at least two filaments converge toward each other at a juncture disposed proximate the longitudinal axis between the first longitudinal end and the second longitudinal end. A system including a delivery system and the intraluminal scaffold, as well as a method of delivering the scaffold, is also provided.

Abstract: Implants and methods of making same are provided for treatment or prophylaxis of coronary or peripheral vascular constrictions or vascular occlusions, and particularly, stenoses or restenoses, that comprise FK506 in chemically covalently bound, non-covalently bound or physically immobilized form.

Abstract: The present invention relates to a medical device or implant made at least in part of a high-strength, low-modulus metal alloy comprising niobium, tantalum, and at least one element selected from the group consisting of zirconium, tungsten, and molybdenum. The medical devices according to the present invention provide superior characteristics with regard to biocompatibility, radio-opacity and MRI compatibility.

Abstract: The invention relates to a method and apparatus of reducing stress during stent manufacture. Particularly, the invention is directed to a method and apparatus for expanding a stent using primarily radial loads thereby reducing the stresses that are generated due to the axial loads applied during loading of the stent onto a mandrel or other expansion device. The method of the invention provides for the stepwise expansion of shape memory stents, while reducing the overall stresses that the stent encounters, and thereby improving manufacturing yields due to fractured struts during expansion.

Abstract: A support catheter that can be used to aid positioning of a guidewire and other medical devices. The support catheter includes a catheter body having a length, and a supporting structure formed or disposed in or on the catheter body. The catheter support structure, whether alone or in combination with the other portions of the support catheter, provides flexibility, stiffness, and torqueability to the support catheter.

Abstract: A system for delivering a medical device, such as an angioplasty balloon, includes two catheter shafts. The distal portion of a first shaft includes a first balloon and is narrower than the proximal portion. A second catheter shaft includes a second balloon and is connected to a medial portion of the first shaft. The second shaft includes a guidewire passageway which is in communication with the passageway of a third shaft that is removably connected to the first shaft. The distal tips of the first and second balloons are connected together to allow the system to be advanced to an anatomical site using a single guidewire. A second guidewire may be used to separate the distal ends of the balloons and to position the balloons at vascular bifurcation. A stent can be crimped onto the balloons such that inflation of the balloons implants the stent within the bifurcation.

Abstract: A power driven vessel closure device is configured for closing a hole in a wall of a body lumen. The vessel closure device can include a power operated drive system and a closure element delivery system. The closure element delivery system can be removably, operably, couplable with the power operated drive system. That is, the closure element system can be directly or indirectly attached to and removed from the power operated drive system, or components thereof. The operation of the power operated drive system can operate the closure element delivery system so as to move the closure element within the vessel closure device and deploy the closure element to close the hole.

Abstract: A stent delivery catheter system for accurately positioning a stent in a bifurcated vessel is disclosed. The system includes a catheter having a terminal portion and distal tip that is placed in a main branch of the vessel proximate the bifurcation. A fixed guidewire is attached to distal tip. A port is defined in the terminal portion of the catheter. The port is aligned with an ostium of a side branch of the bifurcated vessel to allow the passage of a stent delivery device, such as a balloon catheter having a stent crimped thereon, into the side branch. Radiopaque bands are positioned on opposite ends of the port. A positioning balloon is included on a surface of the catheter opposite the port and is selectively inflatable to position the radiopaque bands adjacent the side branch ostium. The radiopaque bands are referenced to place the stent proximate the side branch ostium.

Abstract: Systems and methods are disclosed for reinforcing ischemic tissue of a heart. A reinforcing element is initially positioned within a lumen of a delivery needle. The delivery needle is urged into the ischemic tissue and the reinforcing element is urged out of the needle into the ischemic tissue. The reinforcing element may be embodied as a coiled, undulating, or arcuate spring and may include a shape-memory material. A bioabsorbable material may maintain the reinforcing element in a deformed state. The reinforcing element may be tensioned as it is positioned within the myocardium in order to provide a cinching force by means of a cord lock selectively releasing the reinforcing element. The reinforcing element may be embodied as a number of spiral portions secured to a hub and urged outwardly by rotation of the hub.

Abstract: The present invention generally relates to an intraluminal catheter device for use in angioplasty and delivery of a therapeutic agent. Particularly, the present invention is directed to a catheter having an expandable member having a therapeutic agent disposed thereon and a fibrous matrix covering for delivering a therapeutic agent and methods of using the same.

Abstract: A device for treatment of mitral annulus dilation is disclosed, wherein the device comprises two states. In a first of these states the device is insertable into the coronary sinus and has a shape of the coronary sinus. When positioned in the coronary sinus, the device is transferable to the second state assuming a reduced radius of curvature, whereby the radius of curvature of the coronary sinus and the radius of curvature as well as the circumference of the mitral annulus is reduced.