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The Passeo-35 Xeo peripheral dilatation catheter is indicated to dilate stenosis in the iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Passeo-35 Xeo is also recommended for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature. The Passeo-18 peripheral dilatation catheter is indicated to dilate stenosis in the femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Passeo-14 is indicated for balloon dilatation of the stenotic portion of a lower limb artery for the purpose of improving perfusion. The Oscar Peripheral Multifunctional Catheter system is indicated for percutaneous transluminal interventions in the peripheral vasculature to provide support during access into and to dilate stenoses in femoral, popliteal and infrapopliteal arteries. The product is also intended for injection of radiopaque contrast media for the purpose of angiography. The Pantera LEO is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion and for post dilatation of coronary stents. The Pantera Pro is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Pantera Pro (balloon diameter 2.0 – 4.0 mm) is also indicated for post-delivery expansion of balloon expandable stents.

BIOTRONIK's Passeo 35 Xeo Catheter is an over-the-wire (OTW) balloon dilatation catheter, indicated for dilatation of stenotic segments in peripheral vessels. The Passeo 35 Xeo Catheter is a dual lumen design with both lumens contained within one tube. The smaller lumen is the balloon inflation/deflation lumen. The larger lumen permits the use of guide wires with a maximum diameter of 0.035" to facilitate advancement of the Passeo 35 Xeo Catheter towards and through the lesion(s) to be dilated. The Passeo-18 peripheral dilatation catheter is intended for dilatation of stenotic segments in peripheral vessels and arteriovenous dialysis fistulae. The dilatation balloon is designed to inflate to a known diameter at a specific inflation pressure consistent with the compliance chart on the label. One radiopaque marker is located at each end of the balloon to facilitate fluoroscopic visualization and positioning of the balloon catheter towards and across the lesion. The dilatation catheter includes a soft tapered tip to facilitate advancement of the catheter. The dilatation catheter has two Luer-ports at the proximal end. One port (inflation port) serves for connecting an inflation device to inflate/deflate the balloon. The other port enables flushing of the guide wire lumen. The dilatation catheter has a hydrophobic silicone coating on the shaft outer surface and a hydrophobic patchwork coating on the balloon. The Passeo-14 peripheral dilatation catheter is intended for the dilatation of stenotic segments in lower limb arteries. The dilatation balloon is designed to inflate to a known diameter at a specific inflation pressure consistent with the compliance chart on the label. One radiopaque marker is located at each end of the balloon to facilitate fluoroscopic visualization and positioning of the balloon catheter towards and across the lesion. The dilatation catheter includes a soft tapered tip to facilitate advancement of the catheter. The dilatation catheter has two Luer-ports at the proximal end. One port (inflation port) serves for connecting an inflation device to inflate/deflate the balloon. The other port enables flushing of the guide wire lumen. The Oscar Peripheral Multifunctional Catheter system is an intravascular balloon catheter system, supplied with a retractable sheath (Oscar Support Catheter), a flexible catheter (Oscar Dilator) and a PTA balloon (Oscar PTA balloon), allowing a variable guide wire support and injection of fluids, and adjustable length inflatable balloon up to 180 mm. The over the wire (OTW) catheter has a retractable sheath allowing the balloon to be inflated at various lengths as determined by the physician. The balloon lengths are graduated with evenly spaced radiopaque markers. The Oscar Peripheral Multifunctional Catheter system is a 4F and 6F catheter system with a shaft working length of 60 cm or 120 cm, compatible with 0.014" (Oscar 4F) and 0.018" (Oscar 6F) guide wires. The device uses a semi-compliant balloon with a size dependent rated burst pressure and an indicated clinical use range of 6 atm to 16 atm. The balloon expands to a set nominal diameter (2.0, 2.5, 3.0, 4.0, 5.0, 6.0 and 7.0 mm). If required, separate PTA balloon catheters in same size range are also available separately. Pantera LEO is a PTCA rapid exchange system with a balloon at the distal end of the catheter. A Luer port at the proximal end enables the attachment of an inflation device for the inflation of the balloon. The catheter provides a lumen, which enables the use of a guide wire to position the catheter. Radiopaque balloon markers aid in the placement of the catheter's balloon segment under fluoroscopy. Pantera Pro is a PTCA rapid exchange system with a balloon at the distal end of the catheter. A Luer port at the proximal end enables the attachment of an inflation device for the inflation of the balloon. The catheter provides a lumen, which enables the use of a guide wire to position the catheter. Radiopaque balloon markers aid in the placement of the catheter's balloon segment under fluoroscopy.

The Excelsior XT-27 Microcatheter and Excelsior XT-27 Flex Microcatheter are intended to assist in the delivery of embolization particles, diagnostic agents (such as contrast media), and interventional devices (such as stents) that are indicated for use in the neurovasculature and with a catheter of 0.027 inches in inner diameter. The Excelsior XT-27 Pre-Shaped Microcatheter and Excelsior XT-27 Flex Pre-Shaped Microcatheter are intended to assist in the delivery of embolization particles, diagnostic agents (such as contrast media), and interventional devices (such as stents) that are indicated for use in the neurovasculature and with a catheter of 0.027 inches in inner diameter.

The subject devices hereafter referred to as Excelsior® XT-27® Microcatheters are sterile, single lumen, 0.027 inch inner diameter (ID) microcatheters with one tip marker designed to aid the physician in accessing distal neurovasculature when used with a guide catheter and steerable guidewire. Graded shaft stiffness ranging from a highly flexible tip to a semi-rigid proximal section aids the physician in tracking over selectively placed guidewires. A luer fitting located on the microcatheter hub is used for the attachment of accessories. One radiopaque tip marker is positioned at the distal tip of the device to facilitate fluoroscopic visualization® XT-27® Microcatheters are coated on the outer surface with Hydrolene™ coating which reduces friction during manipulation in the vessel. The Excelsior® XT-27® Microcatheters are available in effective lengths of both 135 cm (53.1 inch) and 150 cm (59.1 inch), with two distal shaft configurations achieved through distal shaft lengths of 6 cm (XT-27 model) and 18 cm (XT-27 Flex model). Both straight tip and pre-shaped versions are available.

The Artix™ MT thrombectomy device is indicated for: · The non-surgical removal of emboli and thrombi from blood vessels · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The Artix™ MT thrombectomy device is intended for use in the peripheral vasculature. The Artix™ Thin-Walled Sheath is indicated for: · The non-surgical removal of emboli and thrombi from blood vessels. · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. · Use as a conduit for endovascular devices. · Use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel. The funnel provides temporary vascular occlusion during these and other angiographic procedures. The Artix™ Thin-Walled Sheath is intended for use in the peripheral vasculature.

The Artix™ MT is a single-use, over-the-wire catheter device used for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The Artix MT is packaged with the following components: Artix MT (3-6 mm or 4-8 mm) Cleaning accessory 1-Way Stopcock The Artix MT is inserted over-the-wire through a compatible sheath (such as the Artix Thin-Walled Sheath) and advanced until its proximal marker band is distal to the target thrombus. The self-expanding element is deployed by retracting the delivery catheter. Thrombus is engaged and removed by retracting the Artix MT into the sheath and out of the patient. Once the procedure is complete, the system is completely withdrawn from the patient. The Artix™ Thin-Walled Sheath ("Artix Sheath") is a single-use, over-the-wire system designed to facilitate the insertion and guidance of an intravascular catheter into a selected peripheral blood vessel and act as a conduit for endovascular devices. The Artix Sheath also non-surgically aspirates thromboemboli from selected vessels and is capable of infusion/aspiration of fluids into or from a selected vessel. The Artix Sheath is packaged with the following components: Artix Thin-Walled Sheath (65 cm or 90 cm) Sheath Dilator (0.035" guidewire compatibility) Funnel Catheter and Funnel Catheter Dilator (0.035" guidewire compatibility) Funnel Loading Tool (2) Large Bore Syringe, 30 mL The Artix Sheath is inserted over-the-wire and advanced to a desirable position. Any compatible endovascular device, such as the Artix MT, can then be inserted through the Artix Sheath for access into the peripheral vasculature. The provided funnel catheter accessory can also be inserted through the Sheath and deployed to provide flow occlusion of the vessel during the procedure to aid with the system's clot ingestion. Compatible endovascular devices, such as the Artix MT, can be used through the 6 Fr inner diameter of the funnel catheter as well. The provided 30 mL syringe can be used to aspirate clot in the vessel or Sheath and infuse contrast media and other fluids as required. Once the procedure is complete, the funnel catheter (if used) is removed prior to withdrawal of the entire system from the patient, and standard 7 Fr closure devices can be used.

The Swan-Ganz catheters are diagnostic and monitoring tools used for hemodynamic monitoring of adult critically ill patients including but not limited to post major surgical recovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, cardiac disease including heart failure.

The Swan-Ganz catheters are flow-directed pulmonary artery catheters used to monitor hemodynamic pressures. The Swan-Ganz thermodilution catheters provide diagnostic information to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer.

The XO Cath Microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic or therapeutic materials into the vessel.

The subject XO Cath Microcatheter is a single-lumen, metal alloy shaft with micro-cuts for flexibility, designed to support a guidewire during access of the peripheral vasculature, and to provide a conduit for the delivery of embolic applications. The XO Cath Microcatheter is available in two lumen sizes, 2.0Fr and 2.6Fr. The XO Cath 2.0Fr and 2.6Fr Microcatheters are available with a straight or bern tip shape to aid with accessing challenging anatomy. The distal outer surface of the microcatheter is coated with a hydrophilic coating. Radiopaque markers are located at the distal tip to facilitate fluoroscopic visualization. The proximal end incorporates a standard luer for ease of use and to connect with a syringe.

The Peregrine System™ Infusion Catheter is intended for the infusion of diagnostic and therapeutic agents into the perivascular area of the peripheral vasculature.

The Peregrine System Infusion Catheter is a continuous flush catheter designed to deliver diagnostic and therapeutic agents through a vessel wall and into the perivascular space. The catheter contains three distal needles which are deployed using the control handle. Fluids are administered through the proximal injection lumen in the handle, which delivers the fluid through the needles at the distal end of the device. The micro-needles and the guide tubes are radiopaque for fluoroscopic visibility. The device is intended for vessels 3-7 mm in diameter and is compatible with guide catheters of at least 7F.

ScleroSafe Peripheral Venous Aspiration & Infusion Kit with Dual Procedure Syringe (ScleroSafe) is intended for the delivery of Asclera®, an FDA-approved sclerosant (Asclera®), in the treatment of varicosities in superficial veins with a diameter of 2 to 3mm.

The subject device, the ScleroSafe™ 150 mm, ScleroSafe™ 350 mm (or ScleroSafe Peripheral Venous Aspiration & Infusion Kit with Dual Procedure Syringe) is intended for the delivery of FDA-approved sclerosant Asclera® in the treatment of varicosities in superficial veins with a diameter of 2 to 3mm. The ScleroSafe device includes a 5 Fr dual lumen catheter ("DLC"), mountable on a 0.018 inch straight-tipped guidewire in an over-the-wire configuration. The DLC is connected to a hub that splits the catheter into two separate tubes. One of the tubes ends with a blue luer lock for the aspiration extension and the other with a transparent luer lock for the injection. Following needle insertion into the guidewire is removed and a Dual Procedure Syringe ("DPS") is connected to the DLC hub via dedicated luers. The larger syringe (10 ml) is connected to blue luer lock connector (Aspiration Extension) of the smaller syringe (5 ml) is connected to a transparent luer lock connector of the catheter (Injection Extension) so fluids are simultaneously injected through one lumen and aspirated through another lumen. ScleroSafe is provided in two sizes: 150mm and 350mm.

The TriSalus TriNav® LV Infusion System is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

The TriSalus® TriNav® LV Infusion System is a 0.025" lumen microcatheter, a self-expanding tip at the distal end. The TriNav® LV serves as the conduit for physician-specified agents such as contrast agents, flush solutions, and embolic beads. It is compatible with standard guide wires with outer diameter up to 0.018" (0.46 mm), guiding catheters with inner diameter at least 0.048" (1.22 mm), embolic hydrogel particles 500 um or less in size and glass microspheres 110 um or less in size. The TriNav® LV has a PTFE inner liner to provide a lubricious surface for passage of physician-specified agents and other accessory devices. The device is hydrophilically coated. The soft, pliable, self-expanding tip is sized for use in vessels 3.0 mm to 5.0 mm in diameter. An optional, commercially available hemostasis valve (HV) is included. There are two radiopaque markers located at the distal end of the TriNav® LV device to aid in positioning of the self-expanding tip. When in correct position, the self-expanding tip is designed to improve infusion efficiency of compatible embolic agents while maintaining antegrade flow in various size vessels. The TriSalus® TriNav® LV Infusion System is provided sterile (EtO) for single patient use.

The Wallaby 017 Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic devices such as embolization materials such as contrast media as well as delivery of embolic coils.

The Wallaby 017 Micro Catheter is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter. The device is a microcatheter with an inner diameter (ID) of 0.017", designed with a working length of 150 cm. The device has three different tip configurations: straight (0°), 45°, 90°, and is steam shapeable by the user. The device is supplied as a kit with an introducer sheath, shaping mandrel, and mandrel card provided with a single catheter. The distal tip of the Wallaby 017 Micro Catheter is visible under fluoroscopy and the distal shaft of each catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of each microcatheter incorporates a strain relief and a standard luer adapter to facilitate the attachment of accessories. Each catheter has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous vasculature. The Wallaby 017 Micro Catheter is a non-active, surgically invasive device intended for limited duration use within the vasculature.

In selective areas of peripheral veins between 7 and 16 mm in diameter, the Stratus Infusion Catheter is intended for the infusion of diagnostic and therapeutic agents into the vein wall or perivascular area, or intraluminally.

The Stratus™ Infusion Catheter is a peripheral infusion catheter designed to access an intraluminal, intramural, or perivascular vein wall layer and infuse fluid diagnostic and/or therapeutic agents. The Stratus Infusion Catheter is a non-implantable device that is provided sterile and is intended for single patient use. The Stratus Infusion Catheter is designed to accommodate individual vein anatomies or disease progression (e.g., thrombosis), by the catheter platform allowing multiple infusions and infusion locations per device.