COIL SYSTEM ORDERING INFORMATION

Transcription

1 EMBOLIZATION SYSTEM

2 RUBY COIL SYSTEM FRAME with Ruby Standard FILL with Ruby Soft Now with 3 & 40 mm sizes! SYSTEM ANCHOR with Now designed to embolize 3 4 mm vessels! PACK with Coil Now with WAVE Shape and device

3 VOL UME A DVA N TAGE S OF T NE S S A DVA N TAGE a EMBOLIZ ATION SYS T EM CA SE S Splenic Artery Embolization Left Subclavian Embolization 8-system competitor coil in glass model c Bilateral Iliac Embolization Coil 4 Concerto Coils 4 Penumbra Coils % Dr. Frank Arko Dr. Herbert Cordero Evanston Hospital, IL Atrium Health, NC St. Rose Dominican Siena Campus, NV Pelvic Congestion Syndrome Hypogastric Artery Embolization Hepatic Artery Aneurysm % Dr. Thomas Aquisto 30 large volume soft coil in glass model d 30 Conventional Detachable Coil Soft Coils embolize collateral Soft coils pack, forming dense metal occlusion. & Coils c. Terumo AZUR CX Coil 4 mm x delivered through Terumo Progreat Microcatheter into 4 mm glass tube. d. 30 Coil delivered through Penumbra LANTERN High-Flow Microcatheter into 4 mm glass tube. a. 7. mm glass aneurysm. Tests performed and data on file at Penumbra, Inc. Bench test results may not be indicative of clinical performance. L A N T ERN MICROCAT HE T ER O N LY C O I L TO P ROV I D E 0 C M L EN G T H A N D.0 0" T H I C K N E S S Dr. Parag J. Patel Dr. Corey Teigen Dr. James Benenati Medical College of Wisconsin, WI Sanford Health, ND Miami Cardiac and Vascular Institute, FL Pre Fontan Embolization Pulmonary AVM GDA & Gastric Embolization P R EC I SE C O I L D E TAC H M EN T Coil Thickness LANTERN Microcatheter 0.0" Max. Ruby and are the only coils designed to be delivered through a LANTERN High-Flow Microcatheter. 03 diagnostic catheter Coil is not fully deployed (coil is still within the catheter tip) Coil fully deployed and ready to be detached 0 Coils T I P SH A P E S Conventional 3 Coil deployed from LANTERN High-Flow Microcatheter LANTERN Coil Proximal catheter marker 30º.0" Coil alignment marker 40 Max. Conventional 8 Coil 8 microcatheter b. Based on 8 mm coil. 30 b Max..0" Ruby and are fully retractable and resheathable, enabling user to achieve ideal placement in the target vessel. Coil alignment marker passes proximal catheter marker to form T, indicating that Ruby or can now be detached. Dr. Saar Danon Dr. Mahmood Razavi Dr. Dmitri Samoilov Cardinal Glennon Children s Hospital, MO St. Joseph Hospital, CA Medical Center Radiologists, VA

4 VOL UME A DVA N TAGE S OF T NE S S A DVA N TAGE a EMBOLIZ ATION SYS T EM CA SE S Splenic Artery Embolization Left Subclavian Embolization 8-system competitor coil in glass model c Bilateral Iliac Embolization Coil 4 Concerto Coils 4 Penumbra Coils % Dr. Frank Arko Dr. Herbert Cordero Evanston Hospital, IL Atrium Health, NC St. Rose Dominican Siena Campus, NV Pelvic Congestion Syndrome Hypogastric Artery Embolization Hepatic Artery Aneurysm % Dr. Thomas Aquisto 30 large volume soft coil in glass model d 30 Conventional Detachable Coil Soft Coils embolize collateral Soft coils pack, forming dense metal occlusion. & Coils c. Terumo AZUR CX Coil 4 mm x delivered through Terumo Progreat Microcatheter into 4 mm glass tube. d. 30 Coil delivered through Penumbra LANTERN High-Flow Microcatheter into 4 mm glass tube. a. 7. mm glass aneurysm. Tests performed and data on file at Penumbra, Inc. Bench test results may not be indicative of clinical performance. L A N T ERN MICROCAT HE T ER O N LY C O I L TO P ROV I D E 0 C M L EN G T H A N D.0 0" T H I C K N E S S Dr. Parag J. Patel Dr. Corey Teigen Dr. James Benenati Medical College of Wisconsin, WI Sanford Health, ND Miami Cardiac and Vascular Institute, FL Pre Fontan Embolization Pulmonary AVM GDA & Gastric Embolization P R EC I SE C O I L D E TAC H M EN T Coil Thickness LANTERN Microcatheter 0.0" Max. Ruby and are the only coils designed to be delivered through a LANTERN High-Flow Microcatheter. 03 diagnostic catheter Coil is not fully deployed (coil is still within the catheter tip) Coil fully deployed and ready to be detached 0 Coils T I P SH A P E S Conventional 3 Coil deployed from LANTERN High-Flow Microcatheter LANTERN Coil Proximal catheter marker 30º.0" Coil alignment marker 40 Max. Conventional 8 Coil 8 microcatheter b. Based on 8 mm coil. 30 b Max..0" Ruby and are fully retractable and resheathable, enabling user to achieve ideal placement in the target vessel. Coil alignment marker passes proximal catheter marker to form T, indicating that Ruby or can now be detached. Dr. Saar Danon Dr. Mahmood Razavi Dr. Dmitri Samoilov Cardinal Glennon Children s Hospital, MO St. Joseph Hospital, CA Medical Center Radiologists, VA

5 ORDERING INFORMATION COMPLEX STANDARD Frame Diameter Diameter (mm) RBYC030 RBYC03 3 RBYC03 RBYC040 0 RBYC04 4 RBYC043 3 RBYC0 RBYC RBYC0 RBYC RBYC07 7 RBYC08 8 RBYC RBYC RBYC 0 RBYC RBYC0 0 RBYC RBYC0 0 RBYC RBYC RBYC3 3 0 RBYC30 Now! 3 0 RBYC400 Now! 40 0 High-Flow Vessel Sacrifice RUBY COIL SYSTEM COMPLEX SOF T Fill.0 in (. mm) Diameter (mm) RBY4C0 RBY4C0 RBY4C04 4 RBY4C030 3 RBY4C03 RBY4C040 4 RBY4C04 RBY4C0 RBY4C RBY4C RBY4C080 0 RBY4C0 0 RBY4C0 0 DETACHMENT HANDLE Description RH Detachment Handle PACKING COIL Pack Behind Ruby or Backstop The System is indicated for arterial and venous embolizations in the peripheral vasculature. The System should only be used by physicians who have received appropriate training in interventional techniques. The device is intended for single use only. Do not resterilize or reuse. Resterilization and/or reuse may compromise the structural integrity of the device or increase the risk of contamination or infection leading to device failure and/or cross-infection and potential patient injury, illness or death. Do not use kinked or damaged devices. Do not use opened or damaged packages. Return all damaged devices and packaging to the manufacturer/distributor. Use device in conjunction with fluoroscopic guidance. Do not advance or withdraw the device against resistance without careful assessment of the cause using fluoroscopy. For Coils with nominal sizes mm The System is indicated for the embolization of: Intracranial aneurysms Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae Arterial and venous embolizations in the peripheral vasculature For Coils with nominal sizes > mm The System is indicated for arterial and venous embolizations in the peripheral vasculature The System should only be used by physicians who have received appropriate training in interventional techniques. The device is intended for single use only. Do not resterilize or reuse. Resterilization and/or reuse may compromise the structural integrity of the device or increase the risk of contamination or infection leading to device failure and/or cross-infection and potential patient injury, illness or death. Do not use kinked or damaged devices. Do not use opened or damaged packages. Return all damaged devices and packaging to the manufacturer/distributor. Moving or torquing the device against resistance may result in damage to the vessel or device. Maintain a constant infusion of an appropriate flush solution. Possible complications include but are not limited to: acute occlusion; air embolism; allergic reaction and anaphylaxis from contrast media; aneurysm rupture; arteriovenous fistula; coagulopathy; coil herniation into parent vessel; death; device malfunction; distal embolization; emboli; embolic stroke and other cerebral ischemic events; false aneurysm formation; hematoma or hemorrhage at access site of entry; incomplete aneurysm occlusion; infection; intima dissection; intracranial hemorrhage; ischemia; myocardial infarction; neurological deficits including stroke; parent artery occlusion; peripheral thromboembolic events; post-embolization syndrome; premature device detachment; recanalization; renal failure; respiratory failure; revascularization; thromboembolic episodes; vessel spasm, thrombosis, dissection, or perforation. Use device in conjunction with fluoroscopic guidance. Do not advance or retract the device against resistance without careful assessment of the cause using fluoroscopy. If cannot be advanced or retracted, withdraw the device as a unit with the microcatheter. Moving or torquing the device against resistance may result in damage to the vessel or device. Maintain a constant infusion of an appropriate flush solution. Potential complications include but are not limited to: acute occlusion; air embolism; allergic reaction and anaphylaxis from contrast media; coagulopathy; coil herniation into parent vessel; death; device malfunction; distal embolization; emboli; embolic stroke and other cerebral ischemic events; false aneurysm formation; hematoma or hemorrhage at access site of entry; incomplete aneurysm occlusion; infection; intima dissection; intracranial hemorrhage; ischemia; myocardial infarction; neurological deficits including stroke; parent artery occlusion; peripheral thromboembolic events; post-embolization syndrome; premature device detachment; recanalization; renal failure; respiratory failure; revascularization; thromboembolic episodes; vessel spasm, thrombosis, dissection, or perforation. Target Vessel 7 Product Target Vessel (mm) RBY3 Now! 3 3 RBY RBY 4 30 RBY 0 RBY RBY0 Now! RBY Now! 0 0 RBY4 Now! Product RBYJ Now! Coil J-Soft RBYJ Coil J-Soft RBYJ30 Coil J-Soft RBYJ4 Coil J-Soft 4 4 RBYJ0 Coil J-Soft 0 0 LANTERN Delivery Microcatheter The Penumbra Delivery Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic devices, such as occlusion coils to the peripheral and neuro vasculature. The Penumbra Delivery Microcatheters should only be used by physicians who have received appropriate training in interventional techniques. The devices are intended for single use only. Do not resterilize or reuse. Resterilization and/or reuse may result in ineffective catheter coating lubrication, which may result in high friction and the inability to access the target location. Do not use kinked or damaged devices. Do not use open or damaged packages. Return all damaged devices and packaging to the manufacturer / distributor. Use the Penumbra Delivery Microcatheters in conjunction with fluoroscopic visualization. Do not advance or withdraw the Penumbra Delivery Microcatheters against resistance without careful assessment of the cause using fluoroscopy. If the cause cannot be determined, withdraw the device. Moving or torquing the device against resistance may result in damage to the vessel or device. Maintain a constant infusion of an appropriate flush solution. If flow through the device becomes restricted, do not attempt to clear the lumen by infusion. Remove and replace the device. Possible complications include, but are not limited to, the following: acute occlusion; hematoma or hemorrhage at access site; death; intracranial hemorrhage; hemorrhage; infection (at access site); distal embolization; ischemia (cardiac and/or cerebral); embolus (air, foreign body, thrombus, plaque); aneurysm perforation; false aneurysm formation; neurological deficits including stroke; vessel spasm, thrombosis, dissection, perforation or rupture; air embolism; emboli. Tip Shape ID (in) PXSLIMLANSTR PXSLIMLANT4 PXSLIMLANT90 PXSLIMLAN3STR PXSLIMLAN3T4 PXSLIMLAN3T90 PXSLIMLAN0STR PXSLIMLAN0T4 PXSLIMLAN0T Penumbra, Inc. USA One Penumbra Place Alameda, CA 940 USA T F order@penumbrainc.com info@penumbrainc.com Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician. Prior to use, please refer to the Instructions for Use for System, System, and Penumbra Delivery Microcatheters for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. Photographs taken by and on file at Penumbra, Inc. Tests performed and data on file at Penumbra, Inc. Bench test results may not be indicative of clinical performance. Renderings for illustrative purposes only. Individual results may vary depending on a variety of patient-specific attributes. Images used with permission. Consents on file at Penumbra, Inc. Please contact your local Penumbra representative for more information. Copyright 7 8 Penumbra, Inc. All rights reserved. The Penumbra P logo, Ruby,, and LANTERN are registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries. All other trademarks are the property of their respective owners. 33, Rev. C 08/8 USA