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The Medtronic Steerant Super Stiff Guidewire is intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta. The guidewire is not indicated for coronary or neuro vasculature.

Steerant™ Super Stiff Guidewire (herein after referred to as Steerant) is a 0.035" diameter PTFE coated stainless steel guidewire. The Steerant guidewire is offered in 200 cm and 260 cm lengths and incorporates a flexible tip section and inner 8 cm radiopaque tungsten coil for enhanced visibility. The Steerant guidewire is offered in single and double curve tip configurations. The Steerant guidewire is sterile, non-pyrogenic, disposable and for single use only.

The Medtronic Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Guide Catheter is intended to be used in the coronary or peripheral vascular system.

The Sherpa NX Balanced Guide Catheter design is fundamentally the same for both sizes of the device. The guide catheter is designed to provide a pathway for diagnostic and therapeutic devices in the coronary and peripheral vasculature. The basic design of Sherpa Guide Catheters is a cylindrical tube with a proximal and distal end. A single lumen extends from the proximal to the distal end of the catheter. The distal end of the catheter is towards the tip and the proximal end is towards the hub and strain relief. The catheter shaft has side holes present towards the distal end depending on the model. The Sherpa NX Balanced product line has two French sizes available, 6F and 7F. Sherpa is available in a range of lengths from 47 cm to 110 com.

The Medtronic guide catheter is designed to provide a pathway through which therapeutic devices are introduced. The guide catheter is intended to be used in the coronary or peripheral vascular system.

Launcher Guide Catheters are comprised of a cylindrical catheter having a proximal and distal end. A single lumen extends from the proximal to the distal end of the catheter. The distal end is the section of the catheter towards the tip and the proximal end is towards the hub and strain relief. The guide catheter is comprised of a luer hub, strain relief, shaft, segments, tungsten marker band, sleeve, and soft tip. The catheter shaft is made of three distinct layers. The guide catheter is available in various lengths ranging from 45 cm to 130 cm and four French sizes [5F, 6F, 7F, and 8F]. Launcher Guide Catheters have a lubricious inner lumen that runs from the proximal to the distal end of the catheter via a lubricious liner material or coating on the inner lumen.

The Everest 20cc Inflation Device/Survival Kit is to be used to facilitate the use of catheters and guide wires during interventional procedures. The Everest 20cc Inflation Device is designed to inflate/deflate balloon catheters as well as to monitor pressure within the balloon. The Y/Tri-Adapter with Hemostasis Valve is designed to be used on a guiding catheter or dilatation catheter to control backbleeding and to provide a port for introduction of fluids into the interventional system. The Guide Wire Insertion Tool is designed to facilitate placement of a guide wire tip through the Y/ Tri-Adanter and into the wire lumen of an interventional catheter. The Guide Wire Steering Handle is designed to hold a small diameter guide wire and provide a handle for manipulating the wire.

Medtronic's Everest™ Disposable Inflation Device is a sterile 20cc inflation device with a locking mechanism that is operated via a trigger. Normally, the locking mechanism is engaged. Once the trigger is pulled back, the locking mechanism is released and the piston can be manually manipulated. The Everest™ 20 Device is outfitted with a manometer with measuring pressures ranging from vacuum to 20 bars in 0.5bar increments. The Everest™ 30 Device is outfitted with a manometer with measuring pressure reading from vacuum to 30 bars in 1 bar increments. A high pressure connecting tube with a male rotating adapter and a disposable 3-way stopcock are also included to aid in preparation of the device. When purchased as a "Survival Kit", the package includes a Y-/ Tri-Adapter with hemostasis valve, a Guide Wire Insertion Tool and a Steering Handle.

The Pacific Plus PTA Catheter is intended to dilate stenoses in the illiofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent postdilatation in the peripheral arteries.

The Pacific Plus PTA catheter is an Over the Wire (OTW) peripheral balloon catheter, specifically designed for percutaneous transluminal angioplasty (PTA) in stenosed vessel segments. The OTW catheter is used to guide the balloon to the stenosed vessel segment. The balloon is then inflated to dilate the vessel. The catheter is a coaxial dual lumen device. The lumen marked "WIRE" is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum outer diameter of 0.018 in (0.46 mm). The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. The Pacific Plus PTA catheter is available in balloon diameters 4.0 mm - 7.0 mm, and balloon lengths from 20 mm to 300 mm, with 90 cm, 150 cm, and 200 cm catheter lengths. The distal section of the catheter includes a lubricious hydrophilic coating.

The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.

Medtronic 6F Taiga Guiding Catheter is an intravascular catheter that is supplied sterile and intended for single use only. The primary function of the 6F Taiga Guiding Catheter is to provide a pathway through which therapeutic devices are introduced. Medtronic 6F Taiga Guiding Catheter has a 6F outer diameter (0.082") and is be available in variety of curves and lengths, identical to the predicate Medtronic Taiga Guide Catheter. The various curves and lengths available, will allow the catheter to accommodate the varying patient vascular system anatomies

The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX EndoAnchor system is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion. The EndoAnchor may be implanted at the initial endograft placement, or during a secondary (i.e., repair) procedure.

The Heli-FXTM EndoAnchor™ Systems are each comprised of the respective Heli-FX Applier with EndoAnchor Cassette, containing ten EndoAnchor implants; the respective Heli-FX Guides; and the Ancillary EndoAnchor Cassette, containing five EndoAnchor implants. The Heli-FX EndoAnchor System comprises the EndoAnchor implant, an intravascularly-applied suture, supplied with the Heli-FX Applier in a Cassette containing ten (10) EndoAnchor implants, or separately in an Ancillary Cassette containing five (5) EndoAnchor implants; the Heli-FX Applier, a catheter-based device for placement of the EndoAnchor; and the Heli-FX Guide, a deflectable sheath to position the Applier. The EndoAnchor is an endovascularly-placed suture designed to attach aortic endografts to the native vessel wall. The EndoAnchor is manufactured from medical-grade nickel-cobalt wire and is wound in a helical shape. The leading end is sharpened to a conical point to act as an integral needle facilitating atraumatic deployment through the graft material and vessel wall. The proximal end of the EndoAnchor includes a diagonal crossbar, which functions as a suture anchor designed to prevent over penetration of the EndoAnchor. Ten (10) EndoAnchor implants are prepackaged into a cassette, which is supplied with the Heli-FX Applier. The cassette is designed to facilitate easy and accurate loading of the EndoAnchor into the Applier catheter. EndoAnchor implants are also supplied separately in an Ancillary Cassette containing five (5) additional EndoAnchor implants. The Heli-FX Applier is designed to implant the EndoAnchor. The Applier implants one EndoAnchor at a time, and can be used to implant multiple EndoAnchor implants in a single patient. The Applier is designed for use with the Heli-FX Guide. The Applier is a 12Fr (OD) catheter with an integrated control handle. Two Applier lengths are available for anchoring in different regions of the aorta. The Heli-FX Guide is a sterile, single use, disposable device designed to direct the Heli-FX Applier to the desired location for EndoAnchor implantation. The device is compatible with a 0.035" Guide wire. The Heli-FX Guide consists of a 12 Fr-compatible (inner diameter) Guide sheath with integrated control handle, and a matching 12 Fr OD obturator. Deflection of the distal tip of the catheter is accomplished by rotating the Control Knob located on the control handle. The Guide is available in both 62cm (16Fr OD) and 90cm (18Fr OD) working lengths. Multiple deflectable tip lengths are available to accommodate a range of aortic diameters. The Obturator is used during vessel access and is designed to follow the Guide wire and provide access through tortuous vasculature.

The Admiral Xtreme PTA balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Admiral Xtreme is an Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) catheter. The device is provided sterile (EtO). The catheter has a dual-lumen shaft that is branched at the proximal end. One lumen forms the entrance to the central lumen for the guidewire, and the other lumen is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. The catheter and balloon are designed to reach targeted inflation diameters, depending on the balloon size and defined pressure. The Admiral Xtreme is compatible with guidewires with a maximum diameter of 0.035" (0.89 mm) and with 5F, 6F or 7F introducer sheaths depending on balloon size. The catheter is provided with a hydrophilic coating and is available in useable catheter lengths of 80, 130 or 150cm. Balloon sizes range from 3.0mm to 12.0mm in diameter, with balloon lengths from 20mm to 300mm. The balloons reach nominal diameter at 6atm or 8atm (Nominal Pressure) and have Rated Burst Pressure (RBP) of 14atm, 12atm and 11atm depending on the balloon diameter and balloon length.

The Sentrant Introducer Sheath with Hydrophilic Coating is intended to provide a conduit for the insertion of diagnostic or endovascular devices into the vasculature and minimize blood loss associated with such insertions.

The Sentrant Introducer Sheath is a single-use, disposable, hydrophilic-coated catheter designed to provide a flexible and hemostatic conduit for the insertion of endovascular devices and to minimize blood loss associated with vascular procedures. The system is comprised of a dilator and an introducer sheath. The system accommodates a 0.035 in (0.89 mm) guidewire and is available in 28 and 64 cm lengths and in sizes from 12 to 26 Fr in 2 French increments. The dilator is radiopaque and has a flexible tapered tip that facilitates atraumatic tracking through the vasculature. There is a dilator grip at the proximal end of the dilator shaft. The dilator grip has a female Luer taper fitting on the proximal end to allow flushing of the device, and a threaded-feature at the distal end to allow the dilator to be secured to the sheath seal housing (dilator locking mechanism). The introducer sheath is comprised of a hydrophilic-coated, coil-reinforced catheter that is attached to a rigid seal housing containing the hemostatic valve assembly. A sideport extension assembly with a 3-way valve is attached to the seal housing. A radiopaque (RO) marker band is located at the distal tip of the sheath. The device also has a suture loop for attaching it to the patient and a strain relief to minimize kinking of the catheter where it joins to the seal housing.

The SilverHawk and TurboHawk Peripheral Plaque Excision System are intended for use in atherectomy of the peripheral vasculature. The SilverHawk and TurboHawk Catheter is NOT intended for use in the coronary, carotid, iliac, or renal vasculature. The TurboHawk Catheter (THS-LS-C, THS-LX-C) is indicated for use in conjunction with the SpiderFX Embolic Protection Device in the treatment of severely calcified lesions.

The SilverHawk and TurboHawk Peripheral Plaque Excision System consists of a Catheter and Cutter Driver, which are packaged separately, but shipped and used together during the plaque excision procedure. The catheter consists of a flexible shaft designed to track over a 0.014" guidewire. At the distal end of the catheter is a small cutting assembly comprised of a rotating inner blade contained within a tubular housing. The proximal end of the Catheter contains a connector and positioning lever designed to fit into a small, disposable, battery driven Cutter Driver, which powers the device. The SilverHawk and TurboHawk Peripheral Plaque Excision System each have two switches: 1) the Cutter Driver main power switch and 2) the Catheter thumb switch. The Cutter Driver main power switch supplies power to the device when turned ON. When the thumb switch is fully forward (OFF), the cutting blade is closed and stored in the cutter housing with the motor off. This position is used during delivery of the device to the target lesion. Once the device has been positioned the Catheter thumb switch is pulled proximally to the ON position to activate the drive shaft and engage the cutter. Pulling back on the Catheter thumb switch simultaneously turns on the motor and causes the distal portion of the cutter housing to deflect, forcing the device against the target lesion. At the same time, this motion exposes the inner rotating blade, preparing the device for lesion treatment. With the blade spinning, the Catheter is slowly advanced across the lesion, "shaving" occlusive material from the artery. The excised tissue is captured and stored in the tip of the device. The cutting process is completed by advancing the Catheter thumb switch distally, deactivating the drive shaft, disengaging the cutter, and aligning the cutter and housing. The Catheter thumb switch is fully advanced distally to the OFF position in order to move the cutter forward within the tip and pack the excised plaque into the tip. This cutting sequence is repeated as necessary to achieve the desired degree of plaque excision. The SilverHawk and TurboHawk Peripheral Plaque Excision System uses the following materials: stainless steel, platinum/iridium, carbide w/ 12% nickel binder, titanium, delrin, polyimide, PET lined tecothane, pebax, nylon, Teflon, tungsten carbide, ABS, PVC, silicone, Santoprene, polycarbonate, polypropylene and hydrophilic coating.