Superior technologies for the treatment of arteriovenous malformations Contents ev3 provides a full range of products for interventional neuroradiology therapies. 1. Liquid Embolic System 5 - Onyx™ 2. Flow Directed Microcatheters Here we highlight our outstanding products for the treatment of arteriovenous malformations. We offer a full range of products for the Interventional Neuroradiologist including coils, liquid embolics, microcatheters, guidewires and balloons, which have been developed in close collaboration with leading clinicians and draw on the latest advances in material science technologies. 3. Guidewires ev3 is committed to developing innovative solutions, harnessing the latest technologies, with the ultimate aim of enabling physicians to better treat their patients. 4. Technical Facts 7 - Marathon™ - UltraFlow™ 9 - Mirage™ - SilverSpeed™ - AqWire™ - X-Pedion™ - X-Celerator™ - Onyx™ 10 Contents ev3 provides a full range of products for interventional neuroradiology therapies. 1. Liquid Embolic System 5 - Onyx™ 2. Flow Directed Microcatheters Here we highlight our outstanding products for the treatment of arteriovenous malformations. We offer a full range of products for the Interventional Neuroradiologist including coils, liquid embolics, microcatheters, guidewires and balloons, which have been developed in close collaboration with leading clinicians and draw on the latest advances in material science technologies. 3. Guidewires ev3 is committed to developing innovative solutions, harnessing the latest technologies, with the ultimate aim of enabling physicians to better treat their patients. 4. Technical Facts 7 - Marathon™ - UltraFlow™ 9 - Mirage™ - SilverSpeed™ - AqWire™ - X-Pedion™ - X-Celerator™ - Onyx™ 10 Perfectly controlled flow Onyx, an embolic agent designed for treating intracranial arteriovenous malformations (AVMs), gives physicians outstanding control to achieve almost complete occlusion of an AVM. Unique to ev3, Onyx is a non-adhesive liquid polymer made of ethylene-vinyl-alcohol (EVOH) copolymer in a dimethylsulfoxide (DMS0) solution. In contact with blood, Onyx forms a soft skin that solidifies from the outside inwards. Since Onyx is non-adhesive and has unique solidification characteristics, a large amount of embolic agent can be delivered by a long single injection, which penetrates the nidus microstructure of an AVM. Onyx does not flow uncontrolled, but is ‘pushed’ forward by the physician who can stop and if necessary re-start the flow. This gives excellent control throughout the procedure of Onyx embolisation. Onyx is the only liquid embolic agent that allows a control angiography to be conducted during the procedure in order to assess the rate of occlusion. Fully informed at every stage, the physician can judge if continuing of injection is required. In short, Onyx gives the physician the advantage of control and timing over this complex procedure. Onyx™ - At a glance • excellent visibility • controlled embolisation • controlled injection and delivery method • flexibility to stop and re-start the injection • control angiography during embolic injection • controlled catheter retrieval • available in three viscosities: Onyx 18, Onyx 20 and Onyx 34 4 5 Perfectly controlled flow Onyx, an embolic agent designed for treating intracranial arteriovenous malformations (AVMs), gives physicians outstanding control to achieve almost complete occlusion of an AVM. Unique to ev3, Onyx is a non-adhesive liquid polymer made of ethylene-vinyl-alcohol (EVOH) copolymer in a dimethylsulfoxide (DMS0) solution. In contact with blood, Onyx forms a soft skin that solidifies from the outside inwards. Since Onyx is non-adhesive and has unique solidification characteristics, a large amount of embolic agent can be delivered by a long single injection, which penetrates the nidus microstructure of an AVM. Onyx does not flow uncontrolled, but is ‘pushed’ forward by the physician who can stop and if necessary re-start the flow. This gives excellent control throughout the procedure of Onyx embolisation. Onyx is the only liquid embolic agent that allows a control angiography to be conducted during the procedure in order to assess the rate of occlusion. Fully informed at every stage, the physician can judge if continuing of injection is required. In short, Onyx gives the physician the advantage of control and timing over this complex procedure. Onyx™ - At a glance • excellent visibility • controlled embolisation • controlled injection and delivery method • flexibility to stop and re-start the injection • control angiography during embolic injection • controlled catheter retrieval • available in three viscosities: Onyx 18, Onyx 20 and Onyx 34 4 5 Precision access to distal anatomy Marathon™, the leading flow-directed microcatheter from ev3, also has outstanding flexibility to reach very distal or difficult anatomy, especially when used in conjunction with a Mirage or SilverSpeed 10 guidewire. Its proximal shaft is reinforced with a stainless steel coil structure, for high proximal pushability, and is combined with a very soft flow-directable tip. Marathon has the lowest “true distal tip” and the lowest crossing profile of any flow-directed microcatheter. The outer diameter of the distal tip measures 1.3F and 1.4F at the marker band, giving smooth navigation and access to the lesion. This low profile tip also facilitates easy retrieval from the embolic mass. Many of Marathon’s outstanding characteristics result from its innovative distal Nitinol braiding. Outstanding softness and flexibility are combined with higher kink resistance of Marathon due to the nitinol braid. Its high embolic and angiographic burst resistance substantially improves safety, while its high tensile strength allows Marathon to be retrieved easily and smoothly. When a more flow-directed microcatheter is required UltraFlow, which has a larger 1.5F profile at the distal tip, is a very good choice. Like Marathon, it also works extremely well with the Mirage and SilverSpeed 10 guidewires. Rebar over-the-wire microcatheters, as well as being Onyx compatible, are also suitable for delivering coils. Flow Directed Microcatheters - At a glance Marathon™ • use as flow-directable or over the wire • reinforced proximal shaft for high pushability • 1.3F profile at the distal tip • flexibility gives superb navigation • excellent kink resistance • high embolic and angiographic burst strength • very high tensile strength for easy retrieval • compatible with Onyx • Nitinol braid UltraFlow™ • use as flow-directable or over the wire • 1.5F profile at the distal tip • compatible with Onyx 6 7 Precision access to distal anatomy Marathon™, the leading flow-directed microcatheter from ev3, also has outstanding flexibility to reach very distal or difficult anatomy, especially when used in conjunction with a Mirage or SilverSpeed 10 guidewire. Its proximal shaft is reinforced with a stainless steel coil structure, for high proximal pushability, and is combined with a very soft flow-directable tip. Marathon has the lowest “true distal tip” and the lowest crossing profile of any flow-directed microcatheter. The outer diameter of the distal tip measures 1.3F and 1.4F at the marker band, giving smooth navigation and access to the lesion. This low profile tip also facilitates easy retrieval from the embolic mass. Many of Marathon’s outstanding characteristics result from its innovative distal Nitinol braiding. Outstanding softness and flexibility are combined with higher kink resistance of Marathon due to the nitinol braid. Its high embolic and angiographic burst resistance substantially improves safety, while its high tensile strength allows Marathon to be retrieved easily and smoothly. When a more flow-directed microcatheter is required UltraFlow, which has a larger 1.5F profile at the distal tip, is a very good choice. Like Marathon, it also works extremely well with the Mirage and SilverSpeed 10 guidewires. Rebar over-the-wire microcatheters, as well as being Onyx compatible, are also suitable for delivering coils. Flow Directed Microcatheters - At a glance Marathon™ • use as flow-directable or over the wire • reinforced proximal shaft for high pushability • 1.3F profile at the distal tip • flexibility gives superb navigation • excellent kink resistance • high embolic and angiographic burst strength • very high tensile strength for easy retrieval • compatible with Onyx • Nitinol braid UltraFlow™ • use as flow-directable or over the wire • 1.5F profile at the distal tip • compatible with Onyx 6 7 Superselective access The Mirage or SilverSpeed 10 guidewire, combined with the Marathon or UltraFlow microcatheter, provides the ideal team for achieving superselective access to an AVM. Mirage’s unique 0.008” size provides appropriate support for flow-directed catheter navigation and unsurpassed distal access. With precise torque control and excellent tip shape retention it can reach the most distal anatomy. A durable hydrophilic coating allows Mirage to glide through tortuous vasculature. This is the ideal guidewire for less traumatic navigation. The hydrophilic coating of Mirage also makes insertion into a catheter exceptionally easy while a flexible tip maintains its shape for precise access. For more support, the SilverSpeed guidewire can be used in the initial stages of catheter navigation. When a large 0.018” or 0.035” guidewire is required, the AqWire™ combines the exceptional lubricity of a hydrophilic coating with the durability and kink resistance of a solid Nitinol core. The result is liquidsmooth control in the most tortuous anatomy. Guidewires - At a glance Mirage™ • available in 0.008” • soft coil tip for superselective access • excellent tip shape retention • durable hydrophilic coating • precise torque control SilverSpeed™ • available in 0.010”, 0.014”, 0.016” and 0.018” • shapeable guidewire for direct access • hydrophilic coating for easy insertion • flexible tip for precise access AqWire™ • large 0.018” or 0.035” guidewire • exceptional lubricity • durable and kink resistant X-Pedion™ • available in 0.010” and 0.014” • strong support for balloons and microcatheters • exceptional pushability and force transmission X-Celerator™ • available in 0.010” and 0.014” • for swift and efficient exchanges • hydrophilic and proximal PTFE coating 8 9 Superselective access The Mirage or SilverSpeed 10 guidewire, combined with the Marathon or UltraFlow microcatheter, provides the ideal team for achieving superselective access to an AVM. Mirage’s unique 0.008” size provides appropriate support for flow-directed catheter navigation and unsurpassed distal access. With precise torque control and excellent tip shape retention it can reach the most distal anatomy. A durable hydrophilic coating allows Mirage to glide through tortuous vasculature. This is the ideal guidewire for less traumatic navigation. The hydrophilic coating of Mirage also makes insertion into a catheter exceptionally easy while a flexible tip maintains its shape for precise access. For more support, the SilverSpeed guidewire can be used in the initial stages of catheter navigation. When a large 0.018” or 0.035” guidewire is required, the AqWire™ combines the exceptional lubricity of a hydrophilic coating with the durability and kink resistance of a solid Nitinol core. The result is liquidsmooth control in the most tortuous anatomy. Guidewires - At a glance Mirage™ • available in 0.008” • soft coil tip for superselective access • excellent tip shape retention • durable hydrophilic coating • precise torque control SilverSpeed™ • available in 0.010”, 0.014”, 0.016” and 0.018” • shapeable guidewire for direct access • hydrophilic coating for easy insertion • flexible tip for precise access AqWire™ • large 0.018” or 0.035” guidewire • exceptional lubricity • durable and kink resistant X-Pedion™ • available in 0.010” and 0.014” • strong support for balloons and microcatheters • exceptional pushability and force transmission X-Celerator™ • available in 0.010” and 0.014” • for swift and efficient exchanges • hydrophilic and proximal PTFE coating 8 9 Onyx: technical facts Onyx, manufactured by ev3, is a next generation polymeric embolisation agent designed for use in the embolisation of brain arteriovenous malformations. The composition and chemical characteristics of Onyx are distinctly different from n-BCA products. Onyx is part of the family of other artificial embolisation agents that include particulate embolic agents, coils and balloons. Onyx is a composition of ethylene vinyl alcohol copolymer (EVOH) solution of dimethyl sulfoxide (DMSO) and suspended micronized tantalum powder. DMSO is an excellent solvent for the liquid delivery of EVOH, while tantalum powder provides contrast for fluoroscopic visualisation. The DMSO solvent dissipates into the blood and interstitial fluids, causing the EVOH copolymer and suspended tantalum to precipitate in situ into a spongy, coherent substance. Onyx immediately forms a skin and solidifies from the outside to the inside. Composition of Onyx The different compostions of Onyx determine its properties of viscosity/flow and the degree of visualization when implanted in the vasculature. The numerical term of Onyx describes its viscosity relative to flow. Part EVOH Relative Viscosity Onyx-18 6% 18 Onyx-20 6.5% 20 Onxy-34 8% 34 PEOPLE. IDEAS. PASSION. Choosing the correct composition Onyx 18 or Onyx 20 are generally chosen when nidal position of the AVM can be achieved and for slow flow feeders. Onyx 34 is designed for higher flow AVMs or fistulous components. In short, Onyx gives the physician the advantage of control and timing over this complex procedure. ev3 Europe SAS 16 rue Washington 75008 Paris France PH +33 (0) 156 88 59 10 FX +33 (0) 156 88 59 11 ev3 Inc. 9600 54th Avenue N. Plymouth, MN 55442-2111 USA PH +1 763 398 7000 FX +1 763 398 7001 Tollfree +800 716 6700 www.ev3.net ev3 Benelux PH +31 (0) 433 659 223 FX +31 (0) 433 650 283 ev3 France PH +33 (0) 156 88 31 10 FX +33 (0) 156 88 31 11 ev3 Italy PH +39 0331 781 212 FX +39 0331 780 499 ev3 Spain PH +34 91 656 7154 FX +34 91 656 7214 ev3 International Distribution Centre Europalaan 25 6199 AB Maastricht-Airport The Netherlands PH +31 (0) 43 365 9228/9 FX +31 (0) 43 364 6395 ev3 Germany, Austria PH +49 228 528 830 FX +49 228 528 8360 ev3 Nordic PH +46 878 325 60 FX +46 878 325 69 ev3 United Kingdom PH +44 1279 659 900 FX +44 1279 654 900 0120 Onyx, UltraFlow HPC, Marathon, Rebar, Silverspeed and Mirage are trademarks of Micro Therapeutics Inc. © 2005 Micro Therapeutics Inc. 10 75572 Rev B BALLOONS • CATHETERS • COILS • EMBOLIC PROTECTION • GUIDEWIRES AND SNARES • LIQUID EMBOLICS • STENTS • THROMBUS MANAGEMENT Onyx: technical facts Onyx, manufactured by ev3, is a next generation polymeric embolisation agent designed for use in the embolisation of brain arteriovenous malformations. The composition and chemical characteristics of Onyx are distinctly different from n-BCA products. Onyx is part of the family of other artificial embolisation agents that include particulate embolic agents, coils and balloons. Onyx is a composition of ethylene vinyl alcohol copolymer (EVOH) solution of dimethyl sulfoxide (DMSO) and suspended micronized tantalum powder. DMSO is an excellent solvent for the liquid delivery of EVOH, while tantalum powder provides contrast for fluoroscopic visualisation. The DMSO solvent dissipates into the blood and interstitial fluids, causing the EVOH copolymer and suspended tantalum to precipitate in situ into a spongy, coherent substance. Onyx immediately forms a skin and solidifies from the outside to the inside. Composition of Onyx The different compostions of Onyx determine its properties of viscosity/flow and the degree of visualization when implanted in the vasculature. The numerical term of Onyx describes its viscosity relative to flow. Part EVOH Relative Viscosity Onyx-18 6% 18 Onyx-20 6.5% 20 Onxy-34 8% 34 PEOPLE. IDEAS. PASSION. Choosing the correct composition Onyx 18 or Onyx 20 are generally chosen when nidal position of the AVM can be achieved and for slow flow feeders. Onyx 34 is designed for higher flow AVMs or fistulous components. In short, Onyx gives the physician the advantage of control and timing over this complex procedure. ev3 Europe SAS 16 rue Washington 75008 Paris France PH +33 (0) 156 88 59 10 FX +33 (0) 156 88 59 11 ev3 Inc. 9600 54th Avenue N. Plymouth, MN 55442-2111 USA PH +1 763 398 7000 FX +1 763 398 7001 Tollfree +800 716 6700 www.ev3.net ev3 Benelux PH +31 (0) 433 659 223 FX +31 (0) 433 650 283 ev3 France PH +33 (0) 156 88 31 10 FX +33 (0) 156 88 31 11 ev3 Italy PH +39 0331 781 212 FX +39 0331 780 499 ev3 Spain PH +34 91 656 7154 FX +34 91 656 7214 ev3 International Distribution Centre Europalaan 25 6199 AB Maastricht-Airport The Netherlands PH +31 (0) 43 365 9228/9 FX +31 (0) 43 364 6395 ev3 Germany, Austria PH +49 228 528 830 FX +49 228 528 8360 ev3 Nordic PH +46 878 325 60 FX +46 878 325 69 ev3 United Kingdom PH +44 1279 659 900 FX +44 1279 654 900 0120 Onyx, UltraFlow HPC, Marathon, Rebar, Silverspeed and Mirage are trademarks of Micro Therapeutics Inc. © 2005 Micro Therapeutics Inc. 10 75572 Rev B BALLOONS • CATHETERS • COILS • EMBOLIC PROTECTION • GUIDEWIRES AND SNARES • LIQUID EMBOLICS • STENTS • THROMBUS MANAGEMENT
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