Pipeline Embolization Device The power to redefi ne aneurysm treatment. The Pipeline device redefi nes treatment for large or giant wide-necked aneurysms by reconstructing the parent artery and restoring its natural course. REDEFINE The power to redefi ne aneurysm treatment. PRE-TREATMENT 6-MONTH FOLLOW-UP 1 YEAR FOLLOW-UP 3 YEAR FOLLOW-UP Images courtesy of Henry Woo, MD Pipeline Device Technology As the fi rst approved fl ow diverter in the US market, the Pipeline device provides the power to achieve unparalleled long-term clinical success in the treatment of large or giant wide-necked aneurysms. Image from preclinical study. Scanning electron microscopy (SEM) of rabbit vertebral artery shows that the aneurysmal neck was completely occluded with neointima. The lumbar arteries, vertebral artery, and other branches were all patent.1 Redefi ne: Aneurysm Treatment 2) Patients in whom dual antiplatelet therapy (aspirin and clopidogrel) is contraindicated; 3) Patients who have not received dual antiplatelet agents prior to the procedure; or 4) Patients in whom a pre-existing stent is in place in the parent artery at the target aneurysm location. WARNINGS: 1) While advancing the Pipeline embolization device inside the microcatheter, do not pull back or torque the wire. This may make device release more diffi cult or impossible; 2) Do not rotate the delivery wire for more than 10 full turns. Over-rotation may cause delivery wire breakage. If the Pipeline embolization device does not open after 10 turns, remove the entire system (microcatheter and Pipeline embolization device delivery system) simultaneously; 3) If the capture coil tip of the delivery system becomes stuck in the mesh of a delivered Pipeline embolization device, rotate the wire clockwise while advancing the wire to try to release it, then slowly pull back on the delivery wire; 4) Persons with known allergy to platinum or cobalt/ chromium alloy (including the major elements Platinum, Cobalt, Chromium, Nickel or Molybdenum) may suffer an allergic reaction to the Pipeline embolization device. Images of devices are for illustrative purposes only and may vary from fi nalized sterile product. References: 1. Kallmes DF, Ding YH, Dai D, Kadirvel R, Lewis DA, Cloft HJ. A second-generation, endoluminal, fl ow-disrupting device for treatment of saccular aneurysms. AJNR Am J Neuroradiol. 2009;30(6):1153-1158. 2. PUFs FDA Summary of Safety and Effectiveness Data (SSED) 3. The International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured Intracranial Aneurysms Risk of Rupture and Risks of Surgical Intervention. Neuroradiology. N Engl J Med 1998; 339:1725-1733 4. ISAT: International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping vs endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomized trial. The Lancet, Vol 360, Oct 2002. Product Number Vessel Diameter (mm) Length (mm) FA-77250-10, -12, -14, -16, -18, -202.5010, 12, 14, 16, 18, 20 FA-77275-10, -12, -14, -16, -18, -202.7510, 12, 14, 16, 18, 20 FA-77300-10, -12, -14, -16, -18, -203.0010, 12, 14, 16, 18, 20 FA-71300-25, -30, -353.0025, 30, 35 FA-77325-10, -12, -14, -16, -18, -203.2510, 12, 14, 16, 18, 20 FA-71325-25, -30, -353.2525, 30, 35 FA-77350-10, -12, -14, -16, -18, -203.5010, 12, 14, 16, 18, 20 FA-71350-25, -30, -353.5025, 30, 35 FA-77375-10, -12, -14, -16, -18, -203.7510, 12, 14, 16, 18, 20 FA-71375-25, -30, -353.7525, 30, 35 Product Number Vessel Diameter (mm) Length (mm) FA-77400-10, -12, -14, -16, -18, -204.0010, 12, 14, 16, 18, 20 FA-71400-25, -30, -354.0025, 30, 35 FA-77425-10, -12, -14, -16, -18, -204.2510, 12, 14, 16, 18, 20 FA-71425-25, -30, -354.2525, 30, 35 FA-77450-10, -12, -14, -16, -18, -204.5010, 12, 14, 16, 18, 20 FA-71450-25, -30, -354.5025, 30, 35 FA-77475-10, -12, -14, -16, -18, -204.7510, 12, 14, 16, 18, 20 FA-71475-25, -30, -354.7525, 30, 35 FA-77500-10, -12, -14, -16, -18, -205.0010, 12, 14, 16, 18, 20 FA-71500-25, -30, -355.0025, 30, 35 Catalog NumberOuter Diameter Distal/ProximalInner DiameterWorking LengthDistal Flexible Length FA-55135-10302.8F/3.2F0.027 in135 cm10 cm FA-55150-10302.8F/3.2F0.027 in150 cm10 cm Pipeline Embolization Device Marksman Micro Catheter COVIDIEN, COVIDIEN with logo and Covidien logo are US and internationally registered trademarks of Covidien AG. Other brands are trademarks of a Covidien company. 2012 Covidien. 76665-001 (A) SEP/12 9775 Toledo Way Irvine, CA 92618 USA 949-837-3700 t 949-837-2044 f www.covidien.com