Chronic total occlusion (CTO) of the coronaries

Transcription

1 Wired for Success Guidewire escalation and techniques for successful crossing of chronic total occlusions. BY JON C. GEORGE, MD; TROY TRAYER, DO; AND RICHARD KOVACH, MD Chronic total occlusion (CTO) of the coronaries has long been a known challenge for percutaneous coronary intervention. As the prevalence of peripheral arterial disease escalates, we are increasingly being confronted with complex superficial femoral artery (SFA) and below-the-knee CTO interventions. Our characterization of how CTOs develop is limited by the late stage of diagnosis and lack of data on the initial formative basis. Animal studies have attempted to develop a better understanding of the composition of CTOs. From these studies, we have theorized that the common initiating event is an acute arterial occlusion due to atherosclerotic plaque rupture with thrombus formation that triggers an inflammatory reaction. During the first 2 weeks of this process, an acute complex is formed that contains platelets and erythrocytes within a fibrin mesh with an influx of acute inflammatory cells. 1 During the intermediate stage at 6 weeks, negative arterial remodeling and disruption of the internal elastic lamina ensues, with intense neovascularization and CTO perfusion. 2 The subsequent 12- to 24-week time period demonstrates decreased microvessel formation and CTO perfusion with progressive gradual replacement of proteoglycans by collagen and calcium. The density of the fibrocalcific tissue is highest at the proximal and distal ends of the lesion: the proximal fibrous cap is characteristically composed of densely packed type I, III, V, and VI collagen, which is the initial barrier to the CTO, 3 whereas the distal fibrous cap tends to be a thinner and softer, yet densely packed collagen structure (Figure 1). Within the main body of the CTO, organized thrombus and recanalization channels are observed (Figure 2) in 60% of lesions. 2 CTOs that are < 1 year old are usually composed of soft or cholesterol-laden foam cell lesions. In contrast, older CTOs typically contain hard plaque that is composed of fibrocalcific iron and hemosiderin deposits within the lesions (Figure 3). GUIDEWIRE SELECTION A foundational knowledge of the composition of CTOs is essential for the selection of an appropriate guidewire (Figure 4), which can consecutively increase success rates to cross CTOs, improve device delivery, control cost, and limit the risk of vascular injury. 4 Although crossing a CTO alone may require a progressive escalation of guidewire choice, A Figure 1. Hard or fibrocalcific CTO with extensive calcification (arrows; A). Soft or lipid-laden CTO intimal plaque with extensive cholesterol deposition (arrow; B). 2 subsequent guidewire exchanges may be further required during the procedure to achieve optimal or safer device delivery. Ultimately, a fundamental understanding of guidewire selection (see Peripheral Guidewires insert at the end of this article) and performance characteristics (Table 1) is of paramount importance to successful completion of a complex endovascular CTO intervention. First, the core diameter of the wire must be decided upon, which is the functional guidewire diameter with standard sizes of 0.014, 0.018, and inches. Large-diameter wires, such as the inch Magic Torque guidewire from Boston Scientific Corporation (Natick, MA) generally have greater rail support and can be used to straighten vessels and improve torque, whereas small-diameter wires have increased flexibility and trackability through tortuous segments. Second, the core material composition of the wire further corresponds to guidewire rigidity, torquability, and flexibility. Stainless steel is easier to torque and is more rigid, providing better columnar support compared to nitinol, which offers more flexibility and kink resistance. Meanwhile, hybrid wires have the benefit of high-tensile stainless steel shafts with nitinol tips to impart high torquability and columnar shaft strength with kink-resistant tips. Third, core taper enables acute angulated vessel access and improved tracking. Abrupt or short tapers create support in shorter distances and have a greater tendency to prolapse compared to long, gradual tapers, which track well around bends but do not provide as much support in short distances. A core that extends to the tip of the wire (core to tip) increases the transmission of force, is more durable and steerable, improves tactile feedback, and is ideal for use in peripheral vessels. A core that does not extend to the tip (shaping ribbon) is delicate, flexible, easier to shape, can be B MARCH 2014 SUPPLEMENT TO ENDOVASCULAR TODAY 1

2 A C Figure 2. CTO lumen recanalization by large central neovascular channels (arrows; A, B). Extensive small, medium, and large intimal plaque neovascular channels (arrows; C). Central lumen, intimal plaque and adventitial neovascular channels formation (solid, open, and curved open arrows, respectively; D). 2 easily prolapsed, and is ideal for navigating tortuous and distal anatomy such as the pedal arteries. Different levels of tip penetration (tip stiffness) provide the wire with more or less push force or tip load to cross challenging lesions. Guidewire covers are sleeves of polymer to enhance lubricity, resulting in less drag, enhanced lesion crossing, and smooth tracking in tortuous vessels. Straight tips or small angles increase tip penetration, while a secondary bend allows for a better angle to navigate tortuous segments. 4 TECHNICAL TIPS AND CONSIDERATIONS Intraluminal Crossing Technical success in crossing long (> 10 cm) SFA occlusions ranges from 50% to 90%. The variability in success depends largely upon lesion length, calcification, distal vessel runoff, and operator experience. Based on the complexity and morphology of the peripheral CTO composition, an escalating guidewire approach needs careful consideration while attempting to cross the CTO. When choosing the first wire to cross this type of lesion from an antegrade approach, a soft wire should be introduced to determine whether the occlusion is an early thrombotic versus a late calcified chronic occlusion. If it is a thrombotic occlusion, then the soft-tipped wire should navigate across the lesion without overt resistance. However, if the wire meets resistance, the next consideration would be a hydrophilic polymer-coated wire, such as the V-18 ControlWire (Boston Scientific Corporation), which allows the operator to direct the wire into a neovascularization microchannel within the CTO. If the operator does not have enough support to navigate through the microchannels, then upgrading to a stiffer core wire will allow the ability to torque through the hard B D plaque or a high tip load wire to penetrate the hard calcific lesions. The Victory guidewire from Boston Scientific is one example of a high tip load guidewire with gram loads ranging from 12 g up to 30 g. Once a thrombotic occlusion has been excluded and the decision to proceed to a stiffer wire has been made, then careful consideration of crossing techniques, guidewire size, and high tip load comes into play. The operator must first choose between intraluminal versus subintimal crossing for the proximal CTO cap. Finessing a guidewire through microchannels of the CTO may decrease the likelihood of severe dissections after balloon inflations compared to looping a guidewire through the proximal cap, which will routinely take a subintimal course. If finessing the guidewire through microchannels is unsuccessful, then guidewire escalation to the high tip load wires will afford further penetration into the CTO proximal cap but at the increased risk of forming subintimal dissection tracts if the guidewire tip does not penetrate the cap. Careful consideration of the appropriate high tip load wire will ensure increased intraluminal crossing success. Typically, an operator will want to start out with a 12-g tip load guidewire and only escalate to a higher tip load (such as a 30 g) if needed. Subintimal Crossing Once attempts at crossing have failed with the previous options, then a stiff hydrophilic wire with a crossing catheter, such as the Rubicon (Boston Scientific Corporation), will supply additional support to facilitate wire passage around the calcified proximal cap in the subintimal space, with the plan to re-enter the true vessel lumen in the distal segment of the CTO. The solid-core, hydrophilic wire possesses resilient properties that allow initial entry into the occlusive lumen, Figure 3. Dense cellular inflammation consisting of lymphocytes (open arrow) and macrophages (closed arrow) within the intimal plaque ( ip ) and media ( m ) of a CTO immediately adjacent to intimal plaque neovascular channels (asterisk). 2 2 SUPPLEMENT TO ENDOVASCULAR TODAY MARCH 2014

3 followed by purposeful creation of a wire loop to pass into the subintimal space. 5 This re-entry technique involves advancing the support catheter past the proximal CTO cap into the subintimal plane and exchanging the larger-diameter stiff wire for a smaller-diameter stiff wire with a shallow bend to assist in navigating back into the true vessel lumen. Figure 4. Guidewire composition. Alternative Access Points Not all CTOs are the same, as the location of the proximal and distal CTO caps, as well as appearance and morphology, all play a major role in the decisions on how to successfully navigate the lesion. For example, a flush ostial SFA occlusion without a visible beak makes an antegrade approach difficult, because the plane of entry into the cap cannot be ascertained. In such cases, retrograde pedal, popliteal, or direct SFA access with guidewire crossing has improved success rates due to the morphology and often softer composition of the distal cap. The choice of access site depends on the length of the CTO, location of reconstitution, and distal vessel runoff. The longer a CTO has been present imparts increasing complexity to the procedure. As the proximal cap hardens over time, retrograde access via a pedal or popliteal artery may be necessary. Once a retrograde sheath has been placed, this often allows for a softer, smalldiameter guidewire to penetrate the thinner distal CTO cap and traverse the occlusion to the patent proximal vessel. When the wire is confirmed to be intraluminal proximal to the occlusion, varying techniques can be employed including finessing the wire retrograde into the antegrade sheath, or snaring the wire using a guidewire retrieval device, to externalize the wire through the femoral sheath and provide a railing for subsequent therapies. If the operator is unable to externalize the wire, then the retrograde access can be converted to a sheathless access to allow for entry of bulkier devices. Advanced Wiring Techniques More complex balloon and wiring techniques for challenging lesion subsets include controlled antegrade and retrograde subintimal tracking (CART) and reverse CART. The CART technique requires that the antegrade wire remain in true lumen at the proximal cap while the retrograde wire is advanced across the distal cap into a subintimal track, utilizing balloon inflation to dissect the subintimal tract until the retrograde wire can be advanced to the proximal wire location for externalization of the retrograde wire. Reverse CART is the same technique except in the reverse direction. Other complex techniques include inflation of a balloon in one subintimal track and puncturing the inflated balloon TABLE 1. GUIDEWIRE CHARACTERISTICS: IMPACT ON CLINICAL PERFORMANCE Feature Performance Characteristics Clinical Relevance Tip: Shape (straight, angle, J) Steerability Vessel access/selection, safety of positioning within vessels Tip: Material Shaping, shape retention Durability and pushability Tip: Taper Tip stiffness Lesion crossability, penetration power Tip: Covers (coils, polymer sleeve) Tactile feedback and torque response Vessel access, lesion crossability Core: Material (stainless steel, nitinol) Torque (steering) and durability Technique to advance/cross, wire durability Core: Diameter Support Device deliverability/pushability Core: Taper length Trackability and support Vessel access, device delivery/pushability Coating (hydrophilic, silicon, PTFE) Lubricity Lesion crossing, smooth tracking of devices MARCH 2014 SUPPLEMENT TO ENDOVASCULAR TODAY 3

4 TIPS FOR OPTIMIZING WIRE SUCCESS If the wire tip prolapses at the cap, use a wire with a higher tip gram load, or advance the support catheter near the tip. If the proximal segment of the tip buckles, use a wire with a higher tip gram load, a hydrophilic-coated wire, or advance a support catheter near the occlusion. If the wire enters the subintimal space and fails to re-enter true lumen, shape/angle the guidewire tip to facilitate reentry, change support to the wire tip by exchanging to a different catheter tip shape, or utilize a re-entry device. If the wire crosses but the device fails to cross, change to a wire with higher rail support, advance the sheath closer to the occlusion, create a wiggle wire, or exchange for a lower-profile system. with a high-tip-load guidewire from the reverse access to create a continuous path from true-to-true lumen. A variation of this technique involves balloon inflation in two subintimal tracks from the antegrade and retrograde approach at the same level to allow dissection of the two planes into a single communicating channel that can be wired in one direction to create a single lumen. Re-Entry Challenges Various re-entry strategies may need to be employed for successful revascularization of CTOs. Re-entry has the highest degree of success in lesions that reconstitute above the adductor canal, where the vessel is relatively large. If the occlusion does not collateralize until the popliteal artery or lower, re-entry becomes more challenging. In SFA CTOs involving the adductor canal, a combination of antegrade and retrograde crossing is utilized, with a preference toward remaining intraluminal, as re-entry in this vascular location has its own challenges. When considering a below-the-knee CTO, finesse from a retrograde approach is paramount to high success rates with a smaller-diameter, soft guidewire, highly torqueable guidewire, such as the Journey guidewire (Boston Scientific Corporation, Natick, MA) for navigating tortuous, small-caliber, and difficultto-access anatomy while remaining intraluminal. If this technique is unsuccessful with a small-diameter guidewire, escalate the wire in a similar stepwise fashion as an antegrade approach by attempting a hydrophilic wire followed by a high tip load wire. If guidewire re-entry fails, the use of a niche device such as the OffRoad Re-entry Catheter System (Boston Scientific Corporation, Natick, MA) may facilitate the passage of the guidewire into the true lumen via an antegrade or retrograde approach. CONCLUSION As endovascular interventionists continue to treat peripheral arterial disease, CTOs will comprise a significant subset of infrainguinal disease. Although newer technologies aim to facilitate crossing of CTOs, the mainstay of endovascular interventions is wiring techniques and fundamentals of wire escalation (see the Tips for Optimizing Wire Success sidebar). The ultimate goal of procedural success and longterm patency is likely related to the success of crossing CTOs while preserving true vessel lumen. n Jon C. George, MD, is with the Division of Interventional Cardiology and Endovascular Medicine, Deborah Heart and Lung Center in Browns Mills, New Jersey. He has disclosed that he is a consultant for Boston Scientific Corporation. Dr. George may be reached at georgej@deborah.org. Troy Trayer, DO, is with the Division of Interventional Cardiology and Endovascular Medicine, Deborah Heart and Lung Center in Browns Mills, New Jersey. He has disclosed that he has no financial interests related to this article. Richard Kovach, MD, is with the Division of Interventional Cardiology and Endovascular Medicine, Deborah Heart and Lung Center in Browns Mills, New Jersey. He has disclosed that he is a consultant for Boston Scientific Corporation. Dr. Kovach may be reached at kovachr@deborah.org. This article was sponsored by Boston Scientific Corporation. Dr. Kovach and Dr. George are being compensated by Boston Scientific for preparing the above article. 1. Jaffe R, Leung G, Munce NR, et al. Natural history of experimental arterial chronic total occlusions. J Am Coll Cardiol. 2009; 53: Srivatsa SS, Edwards WD, Boos CM, et al. Histologic correlates of angiographic chronic total coronary artery occlusions: influence of occlusion duration on neovascular channel patterns and intimal plaque composition. J Am Coll Cardiol. 1997;29: Katsuda S, Okada Y, Minamoto T, et al. Collagens in human atherosclerosis. Immunohistochemical analysis using collagen type-specific antibodies. Arterioscler Thromb. 1992;12: Walker C. Guideline selection for peripheral vascular interventions. Endovasc Today. 2013;12: Nadal LL, Cynamon J, Lipsitz EC, et al. Subintimal angioplasty for chronic arterial occlusions. Tech Vasc Interv Radiol. 2004;7: Figures 1 through 3 reprinted with permission from the Journal of the American College of Cardiology, Srivatsa SS, Edwards WD, Boos CM, et al. Histologic correlates of angiographic chronic total coronary artery occlusions: influence of occlusion duration on neovascular channel patterns and intimal plaque composition. Vol. 29 (5), , 1997, with permission from Elsevier. 4 SUPPLEMENT TO ENDOVASCULAR TODAY MARCH 2014

5 Amplatz Super Stiff Guidewire USE: The Amplatz Super Stiff guidewire facilitates catheter placement and exchange during diagnostic or interventional procedures. Not intended for use in coronary arteries. The tip of the guidewire is not designed to be reshaped. Reshaping of the tip could result in damage to the guidewire. Attention should be paid to guidewire movement in the vessel. Always advance or withdraw a wire slowly. Never push, auger, or withdraw a guidewire which meets resistance. Resistance may be felt tactilely or noted by tip buckling during fluoroscopy. When reintroducing a guidewire into a catheter within a vessel, confirm that the catheter tip is free within the lumen (i.e. not against the vessel wall). Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found call your Boston Scientific representative. CONTRAINDICATIONS: None known. 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. 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, Vessel Spasm, Wire Entrapment/Entanglement, Foreign body/wire Fracture. Some of the stated potential adverse events may require additional surgical intervention. Magic Torque Glidex Coated Hydrophilic Warnings, Precautions, Adverse Events, and Operator s Instructions. INTENDED USE/INDICATION FOR USE: The 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: 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 Guidewire 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 WARNINGS: Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. PRECAUTIONS: Precautions to prevent or reduce clotting should be taken when any catheter is used: A. Consider the use of systemic heparinization. B. Flush or rinse all products entering the vascular system with sterile isotonic saline or a similar solution prior to use. 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. 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 ZIPWire Hydrophilic Guide Wire Warnings, Precautions, Adverse Events, and Operator s Instructions. INTENDED USE: To facilitate the placement of devices during diagnostic and interventional procedures. CONTRAINDICATIONS: There are no known contraindications. WARNINGS: Failure to abide by the following warnings might result in damage to the vessel, shearing of the ZIPwire Hydrophilic Guide Wire and release of plastic fragments from the ZIPwire Hydrophilic Guide Wire. Such pieces or fragments from the ZIPwire Hydrophilic Guide Wire may have to be removed from the vessel. When using a guide wire, potential exists for thrombus formation or emboli, arterial or venous wall damage and/or plaque dislodgment. The physician should be familiar with the literature concerning the complications of angiography. ADVERSE EVENTS: Potential adverse events (in alphabetical order) that may be associated with the use of a guide wire include, 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 Pseudoaneurysm Renal Failure Stroke Vascular thrombosis Vessel occlusion Vessel perforation, dissection, trauma, or damage Vessel spasm Starter Guidewire Warnings, Precautions, Adverse Events, and Operator s Instructions. INTENDED USE: Starter guidewires are designed for percutaneous vessel entry using the Seldinger technique to facilitate subsequent introduction(s) of an intravascular device. WARNINGS: Vessel trauma may result from the improper use of this device. Follow the enclosed directions carefully. PRECAUTIONS: Starter guidewires 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 Platinum Plus Guidewire 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. 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 Thruway.014 Guidewire Warnings, Precautions, Adverse Events, and Operator s Instructions. INTENDED USE/ INDICATIONS FOR USE: The Thruway Guidewire 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. WARNINGS/ADVERSE REACTIONS: The complications that may result from the use of a guidewire in a procedure include: Vessel perforation, dissection, trauma or damage Embolism Hematoma Infection Vessel spasm Hemorrhage Renal Failure Myocardial Infarction Vascular thrombosis Stroke Death Thruway.018 Guidewire Warnings, Precautions, Adverse Events, and Operator s Instructions. INTENDED USE: The Thruway Guidewire 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. ADVERSE EVENTS: The complications that may result from the use of a guidewire in a procedure include: Vessel perforation, dissection, trauma or damage Embolism Hematoma Infection Vessel spasm Hemorrhage Renal Failure Myocardial Infraction Vascular thrombosis Stroke Death V-14 ControlWire Guidewire wice Coating USE: Boston Scientific V-14 ControlWire Guidewire is intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during Percutaneous Transluminal Angioplasty (PTA) or other intravascular interventional procedures. The V-14 ControlWire Guidewire is not intended for use in the cerebral vasculature. The devices are provided nonpyrogenic, sterile, and intended for one procedure only. CONTRAINDICATIONS: None known. WARNINGS: The V-14 ControlWire Guidewires should be used only by physicians trained in angiography and PTA. Vessel trauma may result from the improper use of this device.adverse EVENTS: Potential adverse events which may result from the use of the device include but are not limited to: Allergic reaction Contrast induced renal insufficiency or renal failure Death Embolism Hematoma at the puncture site Hemorrhage Infection Pseudoaneurysm Stroke/cerebral vascular accident (CVA)/transient ischemic attack (TIA) Vascular thrombus Vessel spasm Vessel trauma (dissection, perforation, rupture or injury). Some of the above potential adverse events may require additional surgical intervention. V-18 Control Wire Guidewire wice Coating 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 110 cm V-18 Control Wire guidewire is intended for general intravascular use including the placement of PTA balloon catheters requiring an in guidewire in hemodialysis AV access procedures. The 150, 200 and 300 cm V-18 Control Wire guidewire are intended for general intravascular use.contraindications: Boston Scientific 110 cm 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. 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 Victory Peripheral Guidewire Warnings, Precautions, Adverse Events, and Operator s Instructions. INDICATIONS FOR USE: The Victory guidewires are intended to facilitate the placement and exchange of balloon catheters or other interventional devices within the peripheral vasculature during Percutaneous Transluminal Angioplasty (PTA) or other intravascular interventional procedures. CONTRAINDICATIONS: The Victory guidewires are not intended for use in the coronary or cerebral vasculatures or in patients judged not acceptable for percutaneous intervention. WARNINGS: PRECAUTIONS: This device should be used only by physicians trained in percutaneous, intravascular techniques and/or procedures. Carefully read all instructions prior to use. Observe all warnings and precautions noted throughout these instructions. Failure to do so may compromise guidewire performance and result in complications. ADVERSE EVENTS: Potential adverse events which may result from use of the device include but are not limited to: Hematoma and other access site complications Death Hemorrhage (bleeding) Reaction to contrast media Irritation to vessel causing vessel spasm Vessel dissection or perforation Thrombus formation MARCH 2014 SUPPLEMENT TO ENDOVASCULAR TODAY 5

6 Journey Guidewire USE: Journey Guidewires are intended to facilitate placement and exchange of balloon dilatation catheters or other therapeutic devices during Percutaneous Transluminal Angioplasty (PTA) or other intravascular interventional procedures. The Journey Guidewires are not intended for use in the cerebral vasculature. The devices are provided nonpyrogenic, sterile, and intended for one procedure only. CONTRAINDICATIONS: The Journey Guidewire is not intended for use in the cerebral vasculature. WARNINGS: The Journey Guidewires should be used only by physicians trained in angiography and PTA. Vessel trauma may result from the improper use of this device. Follow the enclosed directions carefully. When the guidewire is in the body, it should be manipulated only under fluoroscopy. PRECAUTIONS: Carefully check and match therapeutic device compatibility to the wire prior to use. ADVERSE EVENTS: Potential adverse events which may result from the use of the device include but are not limited to: Allergic reaction Contrast induced renal insufficiency or renal failure Death Embolism Hematoma at the puncture site Hemorrhage Infection Pseudoaneurysm Stroke/cerebral vascular accident (CVA)/transient ischemic attack (TIA) Vascular thrombus Vessel spasm Vessel trauma (dissection, perforation, rupture or injury) Some of the above potential adverse events may require additional surgical intervention. Rubicon f 35 5f Support Cath USE: The Rubicon Support Catheter is intended to facilitate placement and support of guidewires and other interventional devices within the peripheral vasculature and to allow for exchange of guidewires, and provide a conduit for the delivery of saline or contrast solutions. CONTRAINDICATIONS: None known WARNINGS: The catheter is designed and intended for intravascular use only. This catheter is designed and intended for one time use only. Do not re-sterilize and/or reuse. This catheter should only be used by physicians qualified to perform percutaneous, vascular interventions. These catheters are not designed for use in the coronary arteries or the neurovasculature. Any use for procedures other than those indicated in the instructions is not recommended. PRECAUTIONS: Support Catheters are designed for use by physicians engaged in the practice of a specialized branch of medicine. Use of these devices should be restricted to those specialists trained to perform the procedure. A thorough understanding of the technical principles, clinical applications and risks associated with support catheters is necessary before performing this procedure. Precautions to prevent or reduce clotting should be taken when any catheter is used. Use of systemic heparinization should be considered. ADVERSE EVENTS: Vascular catheterization and/or vascular interventions may result in complications including but not limited to: Access site pain Allergic reaction (drug, contrast, device & other) and neurological reactions Death Hemorrhage or hematoma Impaired blood flow due to thrombosis, embolism, or vasospasm that could lead to tissue infarction, limb amputation, and other thrombo-embolic organ damage such as renal infarction Infection/ Sepsis Vessel injury (dissection, perforation, trauma & rupture) Vasospasm OffRoad Re-entry Catheter System USE: The OffRoad Re-Entry Catheter System is intended to facilitate the placement and positioning of guidewires within the peripheral vasculature beyond stenotic lesions, including sub and chronic total occlusions. CONTRAINDICATIONS: Contraindicated for use in the coronary, cerebral and carotid arteries. WARNINGS: Do not advance the guidewire, the Positioning Balloon Catheter, Micro-Catheter Lancet, or any other component if resistance is met. Do not use a in (0.36 mm) guidewire that has a polymer (plastic) cover/sleeve with the Micro- Catheter Lancet. If using a in (0.36 mm) PTFE coated guidewire, do not manipulate the PTFE coated part of the wire (i.e. back-and-forth movements) beyond the tip of the Micro-Catheter Lancet. Using an inappropriate guidewire may result in damage to the guidewire such as abrasion of the coating, release of polymer fragments or separation of the guidewire. Do not exceed the rated balloon burst pressure. Use an inflation device with a pressure gauge for accurate balloon inflation/deflation. Use only the recommended balloon inflation medium (50/50 solution of saline and contrast medium). Never use air or any gaseous medium to inflate the balloon. PRECAUTIONS: Procedures should be conducted under fluoroscopic guidance with appropriate x-ray equipment. The sealed catheter container should be inspected prior to opening. If the seal is broken, or the container has been damaged, sterility cannot be assured. Careful attention must be paid to maintain tight catheter connections and aspiration before proceeding to avoid air introduction into the system. Before removing the catheter from the sheath, it is important that the balloon is completely deflated. Caution: The catheter system should not be advanced against resistance. The cause of the resistance should be identified and corrective action should be taken. If resistance is felt upon catheter removal from an artery, then the system, guidewire, and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is suspected. Damage may result from kinking, stretching, or forcefully wiping either catheter. Care should be used when handling. The OffRoad Re-Entry Catheter System is not intended for injection of contrast medium into the vessel. Excessive calcification at the site of re-entry may impair performance. ADVERSE EVENTS: Complications that may result from endovascular procedures include, but are not limited to: Allergic reaction (device, contrast medium and medications) Amputation Arteriovenous fistula Death Embolization; air, device, plaque, etc. Hematoma Hemorrhage, including bleeding at the puncture site Pseudoaneurysm Sepsis/Infection Thromboembolic episodes Vessel injury, e.g. dissection, perforation, rupture Vessel occlusion Vessel spasm Results from case studies are not necessarily predicative of results in other cases. Results in other cases may vary. Amplatz, Journey, Meier, Magic Torque, Starter, Thruway, Victory, V-14 Control Wire, V-18 Control Wire, Zipwire, Rubicon, and OffRoad are unregistered or registered trademarks of Boston Scientific Corporation or its affiliates. All other trademarks are the property of their respective owners Boston Scientific Corporation or its affiliates. All rights reserved. PI AB JUL SUPPLEMENT TO ENDOVASCULAR TODAY MARCH 2014