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The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.

The modified AuST Steerable Sheath is a single-use percutaneous catheter intended to provide a pathway through which diagnostic and therapeutic devices are introduced in the human vasculature. The catheter is not intended for neural placements. The modified AuST Steerable Sheath product family consists of a variety of configurations to accommodate different anatomies and/or devices being introduced into the human vasculature. Each of the sheaths in the product family is comprised of a braid-reinforced catheter shaft, bi-directional deflectable segment, radiopaque distal tip, a handle with a 3-way stopcock for flushing and aspiration, and a hemostasis valve to prevent air and fluid leakage.

The Merit Prelude Wave Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guidewires.

The Prelude Wave™ Hydrophilic Sheath Introducer consists of a sheath introducer with compatible vessel dilator that snaps securely into the sheath introducer hub. The sheath hub contains an integral hemostasis valve. The sheath tubing is coated with a hydrophilic coating. A sidearm is affixed to the sheath hub and has a 3-way stopcock at its proximal end. The Prelude Wave™ Hydrophilic Sheath Introducer is available in 11cm and 23cm lengths, (French sizes 4F, 5F, 6F and 7F) and is designed to accept 0.018", 0.021" and 0.025" diameter guidewires. The Prelude Wave™ Hydrophilic Sheath Introducer is marketed with any of the following components, depending on the product configuration: guidewire, metal access needle, access needle with inner metal needle and outer plastic cannula and SnapFix™ securement device.

The PeriCross™ Epicardial Access Kit is intended to access the epicardial surface of the heart via a subxiphoid approach to facilitate electrophysiology studies in adult patients.

The PeriCross™ Epicardial Access Kit is designed to provide safe and reliable access to the epicardium. The kit is supplied sterile and is designed to deliver a .018" guidewire to the pericardial space. The PeriCross™ Epicardial Access Kit consists of the following components: - One (1) PeriCross™ Tunneler Assembly - One (1) PeriCross™ Access Device - One (1) Guidewire – 0.018" OD × 80cm Long - One (1) Coaxial Introducer – 5F × 18cm The PeriCross™ Tunneler assembly consists of a cannula and a removable blunt obturator that, together, create an atraumatic assembly, which is utilized to gain access to the pericardium via the subxiphoid approach. When the tip of the PeriCross™ Tunneler Assembly reaches the pericardial surface, the obturator is removed, leaving a path to the pericardial surface through the open cannula. The PeriCross™ Access Device is inserted into the cannula and secured via a snap connection. The PeriCross™ Access Device incorporates a thumb slide that deploys tines to engage and retract the pericardium away from the surface of the epicardium. The space created allows for the deployment of an integrated 21ga needle to puncture the pericardium in a location away from the heart. The PeriCross™ Access Device prevents inadvertent deployment of the needle and retraction of the tines via an interlock mechanism. A .018" guidewire can then be deployed through the PeriCross™ Access Device. A 5F x 18cm coaxial introducer is provided to allow for subsequent dilation and guidewire exchange to a .032" guidewire.

The Edwards eSheath Optima introducer set is indicated for the introduction and removal of compatible devices used with Edwards transcatheter heart valves.

The Edwards eSheath Optima introducer set consists of a sheath, vessel dilator, introducer, and insheath dilator. The Edwards Optima introducer set is available with inner sheath diameter of 14 French (model 14000ES14). The Edwards eSheath Optima introducer set is used to facilitate introduction of the Edwards transcatheter heart valve systems into the vasculature. The sheath shaft is composed of two layers; as devices are passed through the sheath, the inner member expands by sliding against itself while the outer iacket expands by stretching radially. temporarily expanding the shaft diameter. A radiopaque marker on the distal end indicates the location of the sheath tip in the body and a hydrophilic coating on the sheath tubing exterior facilitates introduction into the vessel. The sheath tubing mates with a housing, which holds three seals to provide hemostasis, and an extension tube with stopcock for flushing. The vessel dilator is used to dilate the vessel prior to sheath insertion. The introducer is inserted into the sheath hub and locked prior to insertion into the body over a guidewire. The in-sheath dilator is used to expand the sheath during device use at the physician's discretion. The introducer, vessel dilator, and in-sheath dilator are radiopaque to improve fluoroscopic visibility intra-procedure. The loader (included in the Edwards delivery system) features a disc valve within the loader cap assembly to help maintain hemostasis, and a scored perforation on the loader tube allowing the loader tubing to be "peeled away" and removed to utilize the full working length of the inserted device.

The ViaOne Epicardial Access System is intended to access the epicardial surface of the heart via a subxiphoid approach to deliver diagnostic and therapeutic interventions for ventricular tachycardia.

ViaOne Epicardial Access System is a sterile, single-use access tool consisting of a concealed needle within a leading channel to facilitate guidewire access into the pericardium through a subxiphoid incision. The device consists of a radiopaque distal tip designed to retract a portion of the pericardial tissue into the device, and away from the heart muscle, where it is punctured by the concealed needle and a guidewire is introduced into the pericardial space.

The iSLEEVE™ Introducer Set is intended to facilitate femoral access to the vascular system for introduction and removal of cardiovascular devices. The iSLEEVE™ Introducer Set is suitable for use in vessels > 5.5 mm diameter.

The iSLEEVE Expandable Introducer Set (iSLEEVE Introducer Set) is a sterile, single-use introducer catheter that provides percutaneous access to the femoral artery for introduction and removal of cardiovascular devices into the vascular system. The iSLEEVE Introducer Set is composed of a dilator and an introducer sheath with a three-way stopcock. The distal end of the introducer sheath is passively expandable which allows for transient sheath expansion when the compatible valve system is introduced through it. Once expanded, this region of the introducer sheath is radially compliant, which allows it to expand and collapse as needed during device delivery and removal. This reduces the time the access vessel is expanded. A hydrophilic coating is applied to the working end of the iSLEEVE introducer sheath which increases the lubricity to aid in delivery when activated. A product mandrel and flushing tube are also supplied with the iSLEEVE Introducer Set.

The Catapult Guide Sheath is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature. The COMPASS Guiding Introducer Sheath is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature. The device is also intended to be used within a pediatric population. The Fortress Introducer Sheath System is intended to provide access and to facilitate percutaneous introduction of guide wres, catheters and other devices into the femoral, popliteal and infrapopliteal arteries while maintaining haemostasis during diagnostic and interventional procedures.

The Introducer Sheath System devices consist of a coil reinforced introducer sheath with hemostasis valve and side port, as well as a dilator with a tapered tip and luer lock at the proximal end. The main introducer sheath tubing is connected at the proximal end to a hemostasis valve with side port tubing that is connected to a plastic color coded 3-way stopcock valve. The side port is used for flushing the introducer sheath. The sheath is introduced into the vascular system with the aid of the dilator. The hemostasis valve at the proximal end of the introducer sheath conforms and seals around guide wires and catheters to reduce blood leakage from the introducer sheath. A radiopaque marker helps identify the distal end of the introducer sheath. The introducer sheath has a lubricious hydrophilic coating on the outer surface in length of 20cm on the distal portion. The System consists of the following components: - A One Introducer Sheath with hemostasis valve - A One or two dilator(s)

The Agilis NxT Steerable Introducer Dual-Reach is indicated for the introduction of various cardiovascular catheters into the heart, including the left side of the heart, during the treatment of cardiac arrhythmias.

The Agilis™ NxT Steerable Introducer Dual-Reach™™ is a sterile, single-use device that consists of a dilator and steerable introducer, which is designed to provide flexible catheter positioning in the cardiac anatomy. The inner diameter of the steerable introducer is 13F. The steerable introducer includes a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. It has a sideport with a three-way stopcock for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The handle is equipped with a rotating collar to deflect the tip clockwise ≥180° and counterclockwise ≥90°. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.

The Element Vascular Access System is indicated for the introduction of therapeutic or diagnostic devices into the vasculature.

The Element Vascular Access System is a medical device system designed to provide a conduit for introduction of therapeutic devices to the peripheral, coronary, and neurovascular anatomy. This device is a three-component system comprised of the BMX81 Delivery Catheter, Penumbra (Neuron 5F) Select Catheter, and a Dilator. The BMX81 Delivery Catheter can be used individually with a 0.038 in [0.97 mm] guidewire or together with the Neuron 5F Select Catheter to access the desired anatomy. The sheath component of the device contains an inner diameter of 6 French (Fr) and lengths ranging from 55 - 115 centimeters (cm).

The Introducer Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.

The Introducer Sheath is intended for establishing a percutaneous access that facilitates the introduction of intravascular devices. The Introducer Sheath is composed of the Guiding Sheath and the Dilator. The Introducer Sheath is available in multiple effective lengths and curve shape configurations.