Optimized for Performance and Ease of Use. Designed with Titanium Oxide Surface. References
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1 References MicroVention data on file low Re-direction Endoluminal Device in treatment of cerebral aneurysms: initial experience with short-term follow-up results, Author: Naci Kocer et al. The RED and RED Jr. systems are currently CE Mark Approved. The RED Jr. system is not approved in the Unites States. The RED system is limited by United States law to investigational use only. RED System and RED Jr. System Product Indications The system is intended for endovascular embolization of intracranial neurovascular aneurysms. The RED and RED Jr. system may also be used with embolic coils for the treatment of intracranial neurovascular lesions. Contraindications Use of the RED system or RED Jr. system is contraindicated under these circumstances: - Patients in whom anticoagulant, antiplatelet therapy or thrombolytic drugs are contraindicated - Patients with known hypersensitivity to nickel-titanium - Patients in whom angiography demonstrated inappropriate anatomy that does not permit passage or deployment of the RED and RED Jr. system Headway Microcatheter Indications The Headway Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils. microvention.com MicroVention, Inc. Worldwide Headquarters 3 Valencia Avenue Tustin, CA 9780 USA PH PH MicroVention UK Limited Suite 3, The Barracks Building 0 Cliffords ort, North Shields Tyne and Wear, NE30 JE United Kingdom PH +44 (0) (0) MicroVention Europe, S.A.R.L. 30 bis, rue du Vieil Abreuvoir 7800 Saint-Germain-en-Laye rance PH +33 () () MICROVENTION, RED and Headway are registered trademarks of MicroVention, Inc. Scientific and clinical data related to this document are on file at MicroVention, Inc. Refer to Instructions for Use, contraindications and warnings for additional information. 06 MicroVention, Inc. MM486(i) EMEA 4/6 MicroVention Deutschland GmbH Hildebrandtstr. 4 D-405 Düsseldorf Germany PH Optimized for Performance and Ease of Use. Designed with Titanium Oxide Surface EMEA
2 MicroVention provides RED, a unique flow diverter stent comprised of two integrated Nitinol braided inner and outer stent layers The RED device has key design characteristics that create an environment for flow diversion, vessel wall apposition and a scaffold for neointimal growth for long term aneurysm occlusion, The RED and RED Jr. systems are CE Marked. The RED Jr. system is not approved in the United States. The RED system is limited by United States law to investigational use only. References: M.A. Möhlenbruch, C. Herweh, L. Jestaedt, S. Stampfl. The RED low-diverter Stent for Intracranial Aneurysms: Clinical Study to Assess Safety and Efficacy. AJNR. ebruary 6, 05 as 0.374/ajnr.A45http://dx.doi.org/0.374/ajnr.A45 Naci Kocer, M.D.,Civan Islak, M.D., Osman Kizilkilic, M.D., low Re-direction Endoluminal Device in treatment of cerebral aneurysms: initial experience with short-term follow-up results. J Neurosurg. March 4, 04; DOI: 0.37/04..JNS344 * Stent inner layer effective metal surface area calculated by measuring stents having the same diameter target vessel. RED System and RED Jr. System Product Indications: The system is intended for endovascular embolization of intracranial neurovascular aneurysms. The RED and RED Jr. system may also be used with embolic coils for the treatment of intracranial neurovascular lesions. Contraindications: Use of the RED system or RED Jr. system is contraindicated under these circumstances: - Patients in whom anticoagulant, antiplatelet therapy or thrombolytic drugs are contraindicated - Patients with known hypersensitivity to nickel-titanium - Patients in whom angiography demonstrated inappropriate anatomy that does not permit passage or deployment of the RED or RED Jr. system Headway Microcatheter Indications: The Headway Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils. microvention.com MicroVention, Inc. Worldwide Headquarters 3 Valencia Avenue Tustin, CA 9780 USA PH PH MicroVention UK Limited Suite 3, The Barracks Building 0 Cliffords ort, North Shields Tyne and Wear, NE30 JE United Kingdom PH +44 (0) (0) MicroVention Europe, S.A.R.L. 30 bis, rue du Vieil Abreuvoir 7800 Saint-Germain-en-Laye rance PH +33 () () MICROVENTION, RED, SOIA, Chaperon and Headway are registered trademarks of MicroVention, Inc. Refer to Instructions for Use, contraindications and warnings for additional information. 06 MicroVention, Inc. MM486(i) EMEA 5/6 MicroVention Deutschland GmbH Hildebrandtstr. 4 D-405 Düsseldorf Germany PH Optimized for Performance and Ease of Use. Designed with Titanium Oxide Surface EMEA
3 MicroVention provides RED, a unique flow diverter stent comprised of two integrated Nitinol braided inner and outer stent layers The RED device has key design characteristics that create an environment for flow diversion, vessel wall apposition and a scaffold for neointimal growth for long term aneurysm occlusion, The RED and RED Jr. systems are CE Marked. The RED Jr. system is not approved in the United States. The RED system is limited by United States law to investigational use only. References: M.A. Möhlenbruch, C. Herweh, L. Jestaedt, S. Stampfl. The RED low-diverter Stent for Intracranial Aneurysms: Clinical Study to Assess Safety and Efficacy. AJNR. ebruary 6, 05 as 0.374/ajnr.A45http://dx.doi.org/0.374/ajnr.A45 Naci Kocer, M.D.,Civan Islak, M.D., Osman Kizilkilic, M.D., low Re-direction Endoluminal Device in treatment of cerebral aneurysms: initial experience with short-term follow-up results. J Neurosurg. March 4, 04; DOI: 0.37/04..JNS344 * Stent inner layer effective metal surface area calculated by measuring stents having the same diameter target vessel. RED System and RED Jr. System Product Indications: The system is intended for endovascular embolization of intracranial neurovascular aneurysms. The RED and RED Jr. system may also be used with embolic coils for the treatment of intracranial neurovascular lesions. Contraindications: Use of the RED system or RED Jr. system is contraindicated under these circumstances: - Patients in whom anticoagulant, antiplatelet therapy or thrombolytic drugs are contraindicated - Patients with known hypersensitivity to nickel-titanium - Patients in whom angiography demonstrated inappropriate anatomy that does not permit passage or deployment of the RED or RED Jr. system Headway Microcatheter Indications: The Headway Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils. microvention.com MicroVention, Inc. Worldwide Headquarters 3 Valencia Avenue Tustin, CA 9780 USA PH PH MicroVention UK Limited Suite 3, The Barracks Building 0 Cliffords ort, North Shields Tyne and Wear, NE30 JE United Kingdom PH +44 (0) (0) MicroVention Europe, S.A.R.L. 30 bis, rue du Vieil Abreuvoir 7800 Saint-Germain-en-Laye rance PH +33 () () MICROVENTION, RED, SOIA, Chaperon and Headway are registered trademarks of MicroVention, Inc. Refer to Instructions for Use, contraindications and warnings for additional information. 06 MicroVention, Inc. MM486(i) EMEA 5/6 MicroVention Deutschland GmbH Hildebrandtstr. 4 D-405 Düsseldorf Germany PH Optimized for Performance and Ease of Use. Designed with Titanium Oxide Surface EMEA
4 RED SYSTEM ORDERING INORMATION RED SYSTEM AND CATHETER SET-UP RED SYSTEM CASE OBSERVATION ROOM OR ADDITIONAL UTURE INSERT HERE RED JR. SYSTEM ORDERING INORMATION RED JR. SYSTEM AND CATHETER SET-UP RED JR. SYSTEM CASE OBSERVATION ROOM OR ADDITIONAL UTURE INSERT HERE 56cm 3 Designed for Performance Outer layer has higher radial force to open the device, while the inner layer is designed to optimize flow diversion A 4 Designed with Titanium Oxide Surface Produced with electropolishing passivation for smoothness and corrosion resistance Smooth delivery through Headway microcatheters The device can be recaptured up to 50% of deployment. This can be done up to three times Clear radiopacity on stent body and flared ends Tortuous Left Internal Carotid Giant Sidewall Aneurysm, RED device, size Tantalum helical strands throughout Courtesy of Dr. Alejandro Ceciliano, Hospital Austral, Argentina device and flared ends allow visible tracking and confirms successful deployment. low Diversion: RED device inner layer provides an average of 37% effective metal surface area. Calculated by measuring stents in the same diameter target vessel High Radial orce due to integrated nitinol design Partially Thrombosed P-P aneurysm (Previously coiled), RED Jr. device, size 30 Courtesy of Dr. Pedro Lylyk, ENERI, Argentina E B Lubricious, yet durable inner liner for smooth stent delivery B. Soft Distal Shaft: C Smooth and atraumatic tracking. High sensitivity to stent deployment 5. Shorter Tip: Designed with a shorter delivery wire for smaller vessels RED Jr. device inner layer provides an average of 30% effective metal surface area. Calculated by measuring stents in the same diameter target vessel Left A to A Segment Sidewall Aneurysm Recannalized, RED Jr. device, size 53 Courtesy of Dr. Riitta Rautio, Turku, inland Reduced friction during navigation in tortuous anatomy and long procedures D. Hybrid Braid And Coil Design: Coil reinforcement provides lumen integrity, bending flexibility and good shape retention. Proximal variable braid reinforcement provides support and torque control. Hybrid design provides : push/pull control for trackability C 7 MONTH OLLOW-UP 3 MONTH OLLOW-UP PLANNING E. Stretch Resistant Shaft: or stability and catheter body twisting prevention Headway Duo Microcatheter Technology Hybrid Braid/Coil Design EATURES PLANNING 3D D C. Lubricious Hydrophilic Coating: 4. low Diversion: 3. Device Opening: Hybrid braid/coil construction, to improve the stent delivery experience A. PTE Liner:. Radiopacity: Designed for Ease of Use TECHNOLOGY Integrated Layers NOW WITH 56cm BENEITS Proximal column strength for stability and torqueability acilitate access to the lesion Distal flexible transitions Smooth device trackability Resistance to kinking and ovalization Controlled device delivery Resistance to stretching Resistance to twisting
5 3 Designed for Performance Integrated Layers Outer layer has higher radial force to open the device, while the inner layer is designed to optimize flow diversion 4 Designed with Titanium Oxide Surface Produced with electropolishing passivation for smoothness and corrosion resistance Designed for Ease of Use Tantalum helical strands throughout device and flared ends allow visible tracking and confirms successful deployment Smooth delivery through Headway microcatheters The device can be recaptured up to 50% of deployment. This can be done up to three times Clear radiopacity on stent body and flared ends Tortuous Left Internal Carotid Giant Sidewall Aneurysm, RED device, size Radiopacity: Courtesy of Dr. Alejandro Ceciliano, Hospital Austral, Argentina 4. low Diversion:. low Diversion: 3. Device Opening: RED device inner layer provides an average of 37% effective metal surface area* High Radial orce due to integrated nitinol design Right Pericallosal Aneurysm, RED Jr. device, size 56 Courtesy of Dr. Saruhan Cekirge, Koru Hospital, Turkey 6 MONTH OLLOW-UP RED Jr. device inner layer provides an average of 30% effective metal surface area* Partially Thrombosed P-P aneurysm (Previously coiled), RED Jr. device, size Shorter Tip: Designed with a shorter delivery wire for smaller vessels Courtesy of Dr. Pedro Lylyk, ENERI, Argentina 3 MONTH OLLOW-UP
6 3 Designed for Performance Integrated Layers Outer layer has higher radial force to open the device, while the inner layer is designed to optimize flow diversion 4 Designed with Titanium Oxide Surface Produced with electropolishing passivation for smoothness and corrosion resistance Designed for Ease of Use Tantalum helical strands throughout device and flared ends allow visible tracking and confirms successful deployment Smooth delivery through Headway microcatheters The device can be recaptured up to 50% of deployment. This can be done up to three times Clear radiopacity on stent body and flared ends Tortuous Left Internal Carotid Giant Sidewall Aneurysm, RED device, size Radiopacity: Courtesy of Dr. Alejandro Ceciliano, Hospital Austral, Argentina 4. low Diversion:. low Diversion: 3. Device Opening: RED device inner layer provides an average of 37% effective metal surface area* High Radial orce due to integrated nitinol design Right Pericallosal Aneurysm, RED Jr. device, size 56 Courtesy of Dr. Saruhan Cekirge, Koru Hospital, Turkey 6 MONTH OLLOW-UP RED Jr. device inner layer provides an average of 30% effective metal surface area* Partially Thrombosed P-P aneurysm (Previously coiled), RED Jr. device, size Shorter Tip: Designed with a shorter delivery wire for smaller vessels Courtesy of Dr. Pedro Lylyk, ENERI, Argentina 3 MONTH OLLOW-UP
7 RED SYSTEM ORDERING INORMATION RED SYSTEM AND CATHETER SET-UP RED SYSTEM CASE OBSERVATION ROOM OR ADDITIONAL UTURE INSERT HERE RED JR. SYSTEM ORDERING INORMATION RED JR. SYSTEM AND CATHETER SET-UP RED JR. SYSTEM CASE OBSERVATION ROOM OR ADDITIONAL UTURE INSERT HERE 56cm 3 Designed for Performance Outer layer has higher radial force to open the device, while the inner layer is designed to optimize flow diversion A 4 Designed with Titanium Oxide Surface Produced with electropolishing passivation for smoothness and corrosion resistance Smooth delivery through Headway microcatheters The device can be recaptured up to 50% of deployment. This can be done up to three times Clear radiopacity on stent body and flared ends Tortuous Left Internal Carotid Giant Sidewall Aneurysm, RED device, size Tantalum helical strands throughout Courtesy of Dr. Alejandro Ceciliano, Hospital Austral, Argentina device and flared ends allow visible tracking and confirms successful deployment. low Diversion: RED device inner layer provides an average of 37% effective metal surface area. Calculated by measuring stents in the same diameter target vessel High Radial orce due to integrated nitinol design Partially Thrombosed P-P aneurysm (Previously coiled), RED Jr. device, size 30 Courtesy of Dr. Pedro Lylyk, ENERI, Argentina E B Lubricious, durable inner liner for smooth stent delivery B. Soft Distal Shaft: C Smooth and atraumatic tracking 5. Shorter Tip: Designed with a shorter delivery wire for smaller vessels RED Jr. device inner layer provides an average of 30% effective metal surface area. Calculated by measuring stents in the same diameter target vessel Left A to A Segment Sidewall Aneurysm Recannalized, RED Jr. device, size 53 Courtesy of Dr. Riitta Rautio, Turku, inland Reduced friction during navigation in tortuous anatomy and during lengthy procedures D. Hybrid Braid And Coil Design: Coil reinforcement provides lumen integrity, bending flexibility and excellent shape retention. Proximal variable braid reinforcement provides support and torque control. Hybrid design provides : push/pull control for trackability C 7 MONTH OLLOW-UP 3 MONTH OLLOW-UP PLANNING E. Stretch Resistant Shaft: or stability and prevention of catheter body twisting Duo Technology Hybrid Braid/Coil Design EATURES PLANNING 3D D C. Lubricious Hydrophilic Coating: 4. low Diversion: 3. Device Opening: Hybrid braid/coil construction, to improve the stent delivery experience A. PTE Liner:. Radiopacity: Designed for Ease of Use TECHNOLOGY Integrated Layers NOW WITH 56cm BENEITS Proximal column strength for stability and torqueability acilitate access to the lesion 56cm working length with distal flexible transitions Smooth device trackability Resistance to kinking and ovalization Controlled device delivery Resistance to stretching Resistance to twisting TECHNOLOGY
8 MicroVention provides RED (low Re-Direction Endoluminal Device), a unique flow diverter stent comprised of two integrated Nitinol braided inner and outer stent layers The device has key design characteristics that create an environment for flow diversion, vessel wall apposition and a scaffold for neointimal growth for long term aneurysm occlusion The RED and RED Jr. systems are CE Marked. The RED Jr. system is not approved in the United States. The RED system is limited by United States law to investigational use only. References: M.A. Möhlenbruch, C. Herweh, L. Jestaedt, S. Stampfl. The RED low-diverter Stent for Intracranial Aneurysms: Clinical Study to Assess Safety and Efficacy. AJNR. ebruary 6, 05 as 0.374/ajnr.A45http://dx.doi.org/0.374/ajnr.A45 Naci Kocer, M.D.,Civan Islak, M.D., Osman Kizilkilic, M.D., low Re-direction Endoluminal Device in treatment of cerebral aneurysms: initial experience with short-term follow-up results. J Neurosurg. March 4, 04; DOI: 0.37/04..JNS344 * Stent inner layer effective metal surface area calculated by measuring stents having the same diameter target vessel. RED System and RED Jr. System Product Indications: The system is intended for endovascular embolization of intracranial neurovascular aneurysms. The RED and RED Jr. system may also be used with embolic coils for the treatment of intracranial neurovascular lesions. Contraindications: Use of the RED system or RED Jr. system is contraindicated under these circumstances: - Patients in whom anticoagulant, antiplatelet therapy or thrombolytic drugs are contraindicated - Patients with known hypersensitivity to nickel-titanium - Patients in whom angiography demonstrated inappropriate anatomy that does not permit passage or deployment of the RED or RED Jr. system Headway Microcatheter Indications: The Headway Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils. microvention.com MicroVention, Inc. Worldwide Headquarters 3 Valencia Avenue Tustin, CA 9780 USA PH PH MicroVention UK Limited Suite 3, The Barracks Building 0 Cliffords ort, North Shields Tyne and Wear, NE30 JE United Kingdom PH +44 (0) (0) MicroVention Europe, S.A.R.L. 30 bis, rue du Vieil Abreuvoir 7800 Saint-Germain-en-Laye rance PH +33 () () MICROVENTION, RED, SOIA, Chaperon and Headway are registered trademarks of MicroVention, Inc. Refer to Instructions for Use, contraindications and warnings for additional information. 06 MicroVention, Inc. MM486(i) EMEA 5/6 MicroVention Deutschland GmbH Hildebrandtstr. 4 D-405 Düsseldorf Germany PH Optimized for Performance and Ease of Use. Designed with Titanium Oxide Surface EMEA
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