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The TXM Support Catheters are percutaneous, single lumen catheters designed for use in the peripheral vascular system. TXM Support Catheters are intended to guide and support a guide wire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

The TXM Support Catheter is an over the wire (OTW) single lumen catheter with atraumatic tapered tip. The distal tip catheter shaft has 6 radiopaque markers (including the tip) that works as an aid to estimate positioning within the vasculature. It consists of a lubricious inner liner made from Teflon, and stainless steel braid over the liner and an outer layer that consists of clear Nylon 12 polymer. One gold marker band is positioned on the proximal side of the tip. A polycarbonate hub is attached to the proximal end of the TXM Support Catheter. The TXM Support Catheter system is offered in 8 models, four with a straight tip and four with an angled tip, and the angled tip configuration has an angle of 30°. All models will have an outer diameter of the 4 French size (0.052") and an inner diameter of 0.039" tapered down to 0.0355" towards the distal tip so that is compatible with a 0.035" guidewires. The device is available in lengths of 65cm, 90cm. 135cm, and 150cm. The catheter is coated with a lubricious hydrophilic coating. The device is supplied sterile and is intended for single use only.

To facilitate the placement of devices during diagnostic or interventional procedures.

The TXM Hydrophilic Guidewire is a hydrophilic coated device which is constructed with a nitinol inner core which is covered with a polyurethane outer layer coated with a lubricious coating to minimize friction during use. The TXM Hydrophilic Guidewire outer diameter is 0.035" and is available in a variety of lengths ranging from 80 cm to 260 cm. The TXM Hydrophilic Guidewire is also constructed in stiff and standard shaft configuration with straight or angled distal tip. The device is supplied sterile and is intended for single use only.

The Guiding Sheath Introducer is intended for use in the hospital catheterization laboratory for the percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and therapeutic procedures.

The Guiding Sheath is intended for intravascular use for the introduction of interventional/diagnostic devices to the human vasculature. The Guiding Sheath is designed to work as a vessel introducer and a guiding catheter. It consists of a lubricous inner liner made from Teflon, and a stainless steel coil over the inner liner. The outer shaft consists of colored Polyether block amide. A Radiopaque Marker band is attached to the distal end of the shaft for radiopacity. The Distal end of the shaft is atraumatic. The Proximal end of the catheter is attached to a Hemostatic Valve. The device is available in three inner diameter sizes of 4Fr, 5Fr, and 6Fr; consisting of 0.063", 0.076" and 0.087" (throughout the shaft) respectably. A lubricious hydrophilic coating shall be applied to the outer diameter of the Catheter Sheath for improved trackability through the vasculature. The device contains a separate Dilator shaft made of two different materials depending on the size. For the 4Fr, Grilamid is used for the body and the Luer attached to the proximal end as well. For the 5Fr and 6F, high densiy polyethylene (HDPE) is used for the body and the Luer attached to the proximal end as well. The distal end of the Dilator is tapered for ease of access to the vessel. The device is available in lengths of 45cm and 90cm. The device is supplied sterile and is intended for single use.

The Guiding Catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vasculature.

The TXM Guiding Catheter is a guiding catheter, for application in intravascular vessels. It consists of a lubricous inner liner made from Teflon, a stainless steel braid over the inner liner. The outer shaft consists of durometer hardness and different lengths of colored Polyether block amide. A Polycarbonate hub is attached to the proximal end of the Guiding Catheter. A strain relief is placed at the proximal end of the Guiding Catheter and over the distal end of the device shafts will have an outer diameter of 5 French sizes (0.070") and 6 French sizes (0.082) respectively for each catheter. The 5 French sizes will have an inner diameter of 0.058" and the 6 French sizes will have an inner diameter of 0.070". The device is available in length of 100cm. The device is supplied sterile and is intended for single use.

The IntraNovo Microcatheter is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremittes, and all coronary vessels. The Microcatheter is also intended for drug infusion in intra-arterial therapy and infusion of embolic materials for hemostasis. The Microcatheter should not be used in cerebral vessels.

The IntraNovo Microcatheter (the "IntraNovo 21" or the "Microcatheter") is an infusion catheter intended for intravascular use. The Microcatheter consists of a single lumen. The shaft consists of a lubricous inner liner made from polytetrafluoroethylene (PTFE) with a stainless steel coil over the inner liner. The outer liner consists of different lengths of colored polyether block amide with varying durometers hardness. A lubricious hydrophilic coating covers the distal end of the IntraNovo Microcatheter. One radiopaque marker band is placed at the distal end of the Microcatheter and above the stainless steel coil. A polycarbonate hub is attached to the proximal end of the Microcatheter with a strain relief placed over the distal end of the hub. The device shaft has an outer diameter of 2.9 French size on the proximal end and 2.4 French size on the distal end with an inner diameter of 0.021" throughout the shaft. The device is available in lengths of 110 cm and 130 cm. The following accessories are included with the Microcatheter: a stainless steel steam shaping mandrel to allow for manual shaping of the distal tip and a 3.0 mL syringe.

The PTA 14 Balloon Dilatation Catheter OTW is intended to dilate stenoses in the iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae.

The PTA 14 Balloon Dilatation Catheter OTW is a 0.014" Over-The-Wire (OTW) PTA Balloon Dilatation Catheter with a semi-compliant inflatable balloon mounted on the distal end of the catheter. It is designed for carrying out percutaneous transluminal angioplasty (PTA) in the peripheral vessels. The balloon catheter has a coaxial shaft design. The outer lumen is used for balloon inflation and the inner lumen (guide wire lumen) permits the use of a guide wire with a maximum outer diameter of 0.014 inch. The proximal segment of the catheter includes one female luer-lock port connected to the inflation lumen, and one female luer-lock for the guide wire lumen. The PTA 14 Balloon Dilatation Catheter is compatible with a 4 Fr. introducer sheath. The device is supplied sterile and is intended for single use.

The IntraNovo 25 Microcatheter is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities, and all coronary vessels. The Microcatheter is also intended for drug infusion in intra-arterial therapy and infusion of embolic materials for hemostasis. The Microcatheter should not be used in cerebral vessels.

The IntraNovo 25 Microcatheter (the "IntraNovo 25" or the "Microcatheter") is an infusion catheter intended for intravascular use. The Microcatheter consists of a single lumen. The shaft consists of a lubricous inner liner made from polytetraflouroethylene (PTFE) with a stainless steel coil over the inner liner. The outer liner consists of different lengths of colored polyether block amide with varying durometers hardness. A lubricious hydrophilic coating covers the distal end of the IntraNovo 25 Microcatheter. Depending on the model, one or two radiopaque marker bands are placed at the distal end of the Microcatheter and above the stainless steel coil. A polycarbonate hub is attached to the proximal end of the Microcatheter with a strain relief placed over the distal end of the hub. The device shaft has an outer diameter of 2.9 French size on the proximal end and 2.7 French size on the distal end with an inner diameter of 0.025" throughout the shaft. The device is available in lengths of 110 cm, 130 cm, and 150 cm. The following accessories are included with the Microcatheter: a stainless steel steam shaping mandrel to allow for manual shaping of the distal tip and a 3.0 mL syringe. The device is supplied sterile and is intended for single use.