Pipeline Embolization Device The power to redefine aneurysm treatment.
REDEFINE The Pipeline device redefines treatment for large or giant wide-necked aneurysms by reconstructing the parent artery and restoring its natural course. PRE-TREATMENT 6-MONTH FOLLOW-UP 1 YEAR FOLLOW-UP The power to redefine aneurysm treatment. 3 YEAR FOLLOW-UP Images courtesy of Henry Woo, MD
Pipeline Device Technology As the first approved flow 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. Redefine: Aneurysm Treatment & Outcomes Reconstruct the parent artery and avoid intrasaccular manipulation Optimized radial force and flexibility 48-strand braided mesh design for flexible conformability 75% cobalt chromium/25% platinum tungsten for radial force and uniform radiopacity Braided mesh design creates scaffolding for endothelial repavement Ability to telescope multiple devices for variable degrees of surface coverage or to create longer constructs Remodel the vessel while keeping perforators open Optimized flow diversion 30-35% surface coverage at nominal diameter 1 Perforators stay open 1 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
Clinical Results The Pipeline device is the most effective long-term solution for treatment of large or giant wide-necked aneurysms. Complete and Durable Occlusion Large ophthalmic aneurysm treated with the Pipeline device. PRE-TREATMENT 1 YEAR FOLLOW-UP 3 YEAR FOLLOW-UP Images courtesy of Tibor Becske, MD and Peter Kim Nelson, MD Long-Term Follow-Up Large ophthalmic aneurysm treated with the Pipeline device. PRE-TREATMENT 1 YEAR FOLLOW-UP 3 YEAR FOLLOW-UP Images courtesy of Henry Woo, MD
Clinical Evidence The PUFs trial proved the safety and efficacy of the Pipeline device for treatment of large or giant wide-necked aneurysms. 2 ANEURYSM CHARACTERISTICS The study was comprised of challenging aneurysms that are difficult to treat successfully with traditional treatments. 3,4 Large or giant wide-necked aneurysms Saccular or fusiform Petrous to superior hypophyseal ICA 0% rate of recurrence for completely occluded aneurysms during trial. 2 PRIMARY EFFICACY ENDPOINT 2 SECONDARY EFFICACY ENDPOINT 2 PRIMARY SAFETY ENDPOINT 2 100 90 80 70 73.6% = 78/106 A 85.7% 81.8% = 78/91 C = 81/99 B 60 50 40 PRE-SET TARGET RATE 30 20 10 0 180 days % of Aneurysms with Complete Occlusion without >50% Stenosis or Alternative Treatment 180 days 1 year % of Aneurysms with Complete Occlusion 5.6% = 6/107 D 180 days PRE-SET TARGET RATE % of Patients with Major Stroke or Neurologic Death at 180 Days A The study enrolled 110 aneurysms. Four were excluded because of wrong location/size or access not obtained. 106 aneurysms were included in the primary efficacy endpoint analysis. B Seven patients without 6-month angiographic follow-up were excluded from this analysis. C Eight additional patients without 1-year angiographic follow-up were excluded from this analysis. D Includes all patients with attempted treatment. 108 patients were enrolled. One patient was excluded from analysis because of an access failure. 107 patients were included in the primary safety endpoint analysis.
Pipeline Embolization Device Product Number Vessel Diameter (mm) Length (mm) Product Number Vessel Diameter (mm) Length (mm) FA-77250-10, -12, -14, -16, -18, -20 2.50 10, 12, 14, 16, 18, 20 FA-77275-10, -12, -14, -16, -18, -20 2.75 10, 12, 14, 16, 18, 20 FA-77300-10, -12, -14, -16, -18, -20 3.00 10, 12, 14, 16, 18, 20 FA-71300-25, -30, -35 3.00 25, 30, 35 FA-77325-10, -12, -14, -16, -18, -20 3.25 10, 12, 14, 16, 18, 20 FA-71325-25, -30, -35 3.25 25, 30, 35 FA-77350-10, -12, -14, -16, -18, -20 3.50 10, 12, 14, 16, 18, 20 FA-71350-25, -30, -35 3.50 25, 30, 35 FA-77375-10, -12, -14, -16, -18, -20 3.75 10, 12, 14, 16, 18, 20 FA-71375-25, -30, -35 3.75 25, 30, 35 FA-77400-10, -12, -14, -16, -18, -20 4.00 10, 12, 14, 16, 18, 20 FA-71400-25, -30, -35 4.00 25, 30, 35 FA-77425-10, -12, -14, -16, -18, -20 4.25 10, 12, 14, 16, 18, 20 FA-71425-25, -30, -35 4.25 25, 30, 35 FA-77450-10, -12, -14, -16, -18, -20 4.50 10, 12, 14, 16, 18, 20 FA-71450-25, -30, -35 4.50 25, 30, 35 FA-77475-10, -12, -14, -16, -18, -20 4.75 10, 12, 14, 16, 18, 20 FA-71475-25, -30, -35 4.75 25, 30, 35 FA-77500-10, -12, -14, -16, -18, -20 5.00 10, 12, 14, 16, 18, 20 FA-71500-25, -30, -35 5.00 25, 30, 35 Marksman Micro Catheter Catalog Number Outer Diameter Distal/Proximal Inner Diameter Working Length Distal Flexible Length FA-55135-1030 2.8F/3.2F 0.027 in 135 cm 10 cm FA-55150-1030 2.8F/3.2F 0.027 in 150 cm 10 cm Results may vary. Not all patients receive the same results. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures at medical facilities with the appropriate fluoroscopy equipment. The Pipeline embolization device should be used by physicians who have received appropriate training for this device. Indications for Use: The Pipeline embolization device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments. CAUTION: Federal (USA) law restricts this device to sale, distribution and use by or on the order of a physician. CONTRAINDICATIONS: The use of the Pipeline embolization device is contraindicated for patients with any of the following conditions: 1) Patients with an active bacterial infection; 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 difficult 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 finalized sterile product. References: 1. Kallmes DF, Ding YH, Dai D, Kadirvel R, Lewis DA, Cloft HJ. A second-generation, endoluminal, flow-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. 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