SEE IT. BELIEVE IT. THE CONFIDENCE OF CLARITY. Solitaire Platinum. Revascularization Device

Transcription

1 SEE IT. BELIEVE IT. THE CONFIDENCE OF CLARITY. Revascularization

2 THE CONFIDENCE OF CLARITY. The key features that make the device effective have been retained including our unique Parametric overlapping stent design but devices are enhanced with distinctive, evenly spaced platinum markers to provide improved visualization for accurate alignment and retrieval. Together, this powerful combination of features gives greater confidence during interventional stroke procedures. INCREASED MARKERS FOR MEANINGFUL VISIBILITY. ALIGN IT! Visualize optimal working length of the device for accurate stent alignment. VISUALIZE IT! Visualize both expansion and compression of the device upon deployment with unique, evenly spaced markers for real-time procedural feedback. RETRIEVE IT! Visualize stent behavior during retrieval for optimal revascularization and clot capture success. Image property of Medtronic. Image property of Medtronic. Images provided by Dr. Italo Linfante, Baptist Miami. THE SOLITAIRE DEVICE IS PROVEN TO REDUCE STROKE RELATED DISABILITY: 2 70% relative improvement in functional independence at 90 days (mrs 0-2) vs IV t-pa alone 90.2% revascularization rate (TICI 2b-) 0% 27 hours.

3 DIFFERENT BY DESIGN. UNIQUE PARAMETRIC DESIGN The overlapping stent design allows the device to expand in larger vessels and compress in smaller vessels during deployment and retrieval as well as: Maintaining consistent stent cell size and structure 7 Differentiated radial outward force,5 Providing multiple planes of clot integration contact DYNAMIC CLOT INTEGRATION 6mm 6% 9% % 26% 7% 2mm Vessel mm Vessel mm Vessel 5mm Vessel mm Vessel mm 0% 27% 8% Simulated measurement (n=) 6mm devices are recommended for use in vessels with a diameter of - mm. Bench testing has been performed to demonstrate the overlapping design of the device that occurs while constrained in vessels with differing diameters.

4 DIFFERENTIATED RADIAL OUTWARD FORCE, BACKED BY DATA WITH WORLDWIDE CASE STUDIES with the Revascularization Normalized Radial Outward Force (N/mm) x0 (n=9) 6x0 (n=0) Radial Outward Force ESCAPE 6 n=5; mrs 0-2 5% SWIFT PRIME 8 n=96; mrs % Nasa Registry 9 n=5; mrs % STRATIS 7 n=98; mrs % THRACE 0 n=; mrs 0-2 5% MR CLEAN 2 n=500; mrs % STAR n=202; mrs % EXTEND-IA n=70; mrs 0-2 7% HERMES Meta-analysis 5 SEER Meta-analysis Vessel Diameter REVASCAT n=206; mrs 0-2.7% EXPANSIVE PORTFOLIO. ENHANCED VISUALIZATION. The family has the options you need for the range clot types you encounter. SFR--0-0 SFR SFR SFR SFR SFR mm 6 mm

5 SOLITAIRE PLATINUM REVASCULARIZATION DEVICE DETAILS Revascularization 20 mm DISTAL MARKERS WORKING LENGTH ROWS OF EVENLY SPACED MARKERS EVERY 0 MM NON- WORKING LENGTH PROXIMAL MARKER PUSH WIRE + INTRODUCER SHEATH distal markers for mm devices. distal markers for 6 mm devices. Revascularization 0 mm DISTAL MARKERS WORKING LENGTH 5 ROWS OF EVENLY SPACED MARKERS EVERY 0 MM NON- WORKING LENGTH PROXIMAL MARKER PUSH WIRE + INTRODUCER SHEATH SOLITAIRE PLATINUM REVASCULARIZATION DEVICE ORDERING INFORMATION 2 Model Recommended Vessel Diameter A Minimum Microcatheter ID Push Wire Length Stent Diameter Stent Length B Proximal Marker to Distal Marker Length Length from Distal Tip to Flourosafe Marker Radiopaque Markers Radiopaque Stent Markers Spacing (min) (max) (in) (cm) (cm) Distal Prox. SFR SFR SFR SFR SFR SFR A Select a Revascularization based on the sizing recommendations in Table and based on the smallest vessel diameter at thrombus site. B Select a Revascularization usable length that is at least as long as the length of the thrombus..tr-nv2692 Rev A Rev. 06/7.TR-NV807 Rev A.TR-NV280 Rev A 5. 6x0 device compared to x0 device 6.Goyal M, Demchuk AM, Menon BK, et al. Randomized assessment of rapid endovascular treatment of ischemic stroke. N. Engl. J. Med. Mar 2 205;72(): Mueller-Kronast NH, Zaidat OO, Froehler MT, et al. Systematic Evaluation of Patients Treated With Neurothrombectomy s for Acute Ischemic Stroke: Primary Results of the STRATIS Registry. Stroke. 207;8(0): Saver JL, Goyal M, Bonafe A, et al. Stent-retriever thrombectomy after intravenous t-pa vs. t-pa alone in stroke. N. Engl. J. Med. Jun 205;72(2): TN Nguyen & Al. Balloon Guide Catheter Improves Revascularization and Clinical Outcomes With the Solitaire. Stroke. 20;5:-5. 0.Serge Bracard, Xavier Ducrocq, et al. Mechanical thrombectomy after intravenous alteplase versus alteplase alone after stroke (THRACE): a randomized controlled trial. Lancet Neurol. 206; 5: 8 7..Jovin TG, Chamorro A, Cobo E, et al. Thrombectomy within 8 hours after symptom onset in ischemic stroke. N. Engl. J. Med. Jun 205;72(2): Berkhemer OA, Fransen PS, Beumer D, et al. A randomized trial of intraarterial treatment for acute ischemic stroke. N. Engl. J. Med. Jan 205;72():-20..Pereira VM, Gralla J, Davalos A, et al. Prospective, multicenter, single-arm study of mechanical thrombectomy using Solitaire Flow Restoration in acute ischemic stroke. Stroke. Oct 20;(0): Campbell BC, Mitchell PJ, Kleinig TJ, et al. Endovascular therapy for ischemic stroke with perfusion-imaging selection. N. Engl. J. Med. Mar 2 205;72(): Goyal M, Menon BK, van Zwam WH, et al. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. Apr 2 206;87(0029): Campbell BC, Hill MD, Rubiera M, et al. Safety and Efficacy of Solitaire Stent Thrombectomy: Individual Patient Data Meta-Analysis of Randomized Trials. Stroke; a journal of cerebral circulation. 206;7(): TR-NV255 Rev A. CAUTION: Federal (USA) law restricts this device to sale, distribution and use by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device Toledo Way Irvine, CA 9268 USA Tel Fax medtronic.com The Revascularization is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-pa). Endovascular therapy with the device should be started within 6 hours of symptom onset. The Revascularization is indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for IV t-pa or who fail IV t-pa therapy are candidates for treatment. 208 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. * Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. DC Rev A APR/208