Guide Wires for Peripheral Interventions

Prescriptive Information

Starter™ Guide Wire
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
Intended Use: Starter guide wires are designed for percutaneous vessel entry using the Seldinger technique to facilitate subsequent introduction(s) of an intravascular device.
Contraindications: None.
Precautions: Starter guide wires should be used only by physicians thoroughly trained in interventional procedures.
Adverse Events: Other potential adverse reactions which may result from the improper use of this device include, but are not limited to: air embolism, hematoma at the puncture site, infection and perforation of the vessel, vessel spasm, hemorrhage, vascular thrombosis.

ZIPwire® Hydrophilic Guide Wire
Federal law (USA) restricts this device to the sale and use by or on the order of a physician.
Intended Use: To facilitate the placement of devices during diagnostic and interventional procedures.
CONTRAINDICATIONS: There are no known contraindications.
ADVERSE EVENTS: Potential adverse events (in alphabetical order) which maybe associated with the use of a guidewire, but are not limited to, the following: Allergic reaction, amputation, death, delayed immune response, embolism, febrile reaction, hematoma, hemorrhage, infection, myocardial ischemia and/or infarction, pseudo aneurysm, renal failure, stroke, vascular thrombosis, vessel occlusion, vessel perforation, dissection, trauma, or damage, vessel spasm.

Amplatz  Super Stiff™ Guidewire
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
Intended Use/Indications For Use: Amplatz Super Stiff guidewire facilitates catheter placement and exchange during diagnostic or interventional procedures. Not intended for use in coronary arteries.
Contraindications: None known.
Adverse Events: Potential adverse events which may result from the use of the device include but are not limited to: air embolism/thromboembolism, allergic reaction, amputation, arteriovenous (AV) fistula, death, embolism, hematoma, hemorrhage, hemoglobinuria, infection or sepsis/infection, myocardial ischemia and/or infarction, pseudoaneurysm, stroke (CVA)/transient ischemic attacks (TIA), thrombus, vessel occlusion, vessel perforation, dissection, trauma, or damage, vessel spasm, wire entrapment/entanglement, foreign body/wire fracture.
Warnings: This device should be used only by physicians with a thorough understanding of angiography and percutaneous interventional procedures. Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. If contrast agents are used, use extreme caution in patients who have had a severe reaction to contrast agents and who cannot be adequately premedicated.

Magic Torque™ Glidex™ Coated Hydrophilic Guidewire
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
Intended Use/Indications for Use: Magic Torque guidewire facilitates placement of a catheter during diagnostic or interventional procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted  side branches.not intended for use in coronary arteries.
Contraindications: None known.
Warnings: Studies have shown that this guidewire material may cause slight irritation in some individuals. This device should be used only by physicians with a thorough understanding of angiography and percutaneous interventional procedures. Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. If contrast agents are used, use extreme caution in patients who have had a severe reaction to contrast agents and who cannot be adequately premedicated.
Adverse Events: Potential adverse events which may result from the use of the device include but are not limited to: air embolism/thromboembolism, allergic reaction, amputation, arteriovenous (AV) fistula, death, embolism, hematoma, hemorrhage, hemoglobinuria, infection or sepsis/infection, myocardial ischemia and/or infarction, pseudoaneurysm, stroke (CVA)/transient ischemic attacks (TIA), thrombus, vessel occlusion, vessel perforation, dissection, trauma, or damage, vessel spasm, wire entrapment/entanglement, foreign body/wire fracture.

Back-up Meier Steerable Guidewires
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
Intended Use/Indications For Use: The Back-up Meier guidewire facilitates catheter placement and exchange during diagnostic or interventional procedures, including abdominal aortic aneurysm (AAA) endovascular graft procedures.
Contraindications: Heavily tortuous vessels, previous diagnosis of severe vessel spasm.
Adverse events: Potential adverse events which may result from the use of the device include but are not limited to: Air Embolism/Thromboembolism; Allergic Reaction; Amputation; Arteriovenous (AV) Fistula; Death; Embolism; Hematoma; Hemorrhage; Hemoglobinuria; Infection or Sepsis/Infection; Myocardial Ischemia and/or Infarction; Pseudoaneurysm; Stroke (CVA)/Transient Ischemic Attacks (TIA); Thrombus; Vessel Occlusion; Vessel Perforation, Dissection, Trauma, or Damage; Vessel Spasm; Wire Entrapment/ Entanglement; and Foreign Body/Wire Fracture.
Precautions: The physician should be familiar with and experienced in standard techniques of percutaneous transluminal angioplasty and knowledgeable of the current medical literature concerning the complications of angioplasty.

Platinum Plus™ Guidewire
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
Intended Use/Indications for Use: The Platinum Plus Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Contraindications: Not intended for use in coronary arteries. Not intended for use in the neurovasculature.
Warnings: This device should be used only by physicians with a thorough understanding of angiography and percutaneous interventional procedures. Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. If contrast agents are used, use extreme caution in patients who have had a severe reaction to contrast agents and who cannot be adequately premedicated.
Adverse Events: Potential adverse events which may result from the use of the device include but are not limited to: Air Embolism/Thromboembolism, Allergic Reaction, Amputation, Arteriovenous (AV) Fistula, Death, Embolism, Hematoma, Hemorrhage, Hemoglobinuria, Infection or Sepsis/Infection, Myocardial Ischemia and/or Infarction, Pseudoaneurysm, Stroke (CVA)/Transient Ischemic Attacks (TIA), Thrombus, Vessel Occlusion, Vessel Perforation, Dissection, Trauma, or Damage, Vessel Spasm, Wire Entrapment/Entanglement, Foreign Body/Wire Fracture.

V-18™ Control Wire® Guidewire with ICE® Hydrophilic Coating
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
Intended Use/Indications For Use: The V-18 Control Wire guidewire is available in 110, 150, 200 and 300 cm lengths. The wire can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. This device is intended for peripheral use only. A torque device (pin vise) is included with each wire to facilitate directional manipulation of the guidewire. The 110cm V-18 Control Wire guidewire is intended for general intravascular use including the placement of PTA balloon catheters requiring an 0.018 in guidewire in hemodialysis AV access procedures. The 150, 200 and 300cm V-18 Control Wire guidewire are intended for general intravascular use.
Adverse Events: Potential adverse events which may result from the use of the device include but are not limited to:
Air Embolism/Thromboembolism; Allergic Reaction; Amputation; Arteriovenous (AV) Fistula; Death; Embolism; Hematoma; Hemorrhage; Hemoglobinuria; Infection or Sepsis/Infection; Myocardial Ischemia and/or Infarction; Pseudoaneurysm; Stroke (CVA)/Transient Ischemic Attacks (TIA); Thrombus; Vessel Occlusion; Vessel Perforation, Dissection, Trauma, or Damage; Vessel Spasm; Wire Entrapment/Entanglement; and Foreign Body/Wire Fracture.
Contraindications: Boston Scientific 110cm Guidewires are not intended for use in the cerebral vasculature.
Precautions: This device should be used only by physicians thoroughly trained in percutaneous, intravascular techniques and procedures.

Thruway™ Guide Wire
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
INTENDED USE/INDICATIONS FOR USE: The Thruway Guide wire facilitates placement of a catheter during diagnostic or interventional peripheral intravascular procedures including but not limited to renal intervention. The wire can be torqued to facilitate navigation through the vasculature.
CONTRAINDICATIONS: Not intended for use in coronary arteries. Not intended for use in the neurovasculature.
WARNING/ADVERSE REACTIONS: The complications that may result from the use of a guide wire in a procedure include: Vessel perforation, dissection, trauma or damage, vessel spasm, hemorrhage, hematoma, vascular thrombosis, embolism, stroke, renal failure, myocardial infarction, infection, death. This device should be used only by physicians with a thorough understanding of angiography and percutaneous interventional procedures.

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