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9.3........................................................................................... 19
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2023

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11.4 PMDA......................................................................................... 20................................................................................................................................. 21................................................................................................................................. 22
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Penumbra, Inc.

Penumbra, IncIndigo System
CLP-27548
2023

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Penumbra, IncIndigo SystemCLP-27548
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101630(306)63030Penumbra. Inc,
1310 Harbor Bay Parkway
Alameda, CA 94502 USA
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1310 Harbor Bay Parkway
Alameda, CA 94502 USA
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NORTH AMERICAN SCIENCE ASSOCIATES, LLC
6750 Wales Rd, Northwood, OH 43619 USA

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CLP-27548
2023

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ALI

1. Veenstra EB, van der Laan MJ, Zeebregts CJ, de Heide EJ, Kater M, Bokkers RPH. A
systematic review and meta-analysis of endovascular and surgical revascularization techniques in acute limb ischemia. J Vasc Surg. 2020;71(2):654-668.e653.
2. Darwood R, Berridge DC, Kessel DO, Robertson I, Forster R. Surgery versus thrombolysis for initial management of acute limb ischaemia. The Cochrane database of systematic reviews. 2018;8:Cd002784.
3. de Donato G, Pasqui E, Sponza M, et al. Safety and efficacy of vacuum assisted thromboaspiration in patients with acute lower limb ischaemia: The INDIAN trial. European
Journal of Vascular and Endovascular Surgery. 2021.
4. Baril DT, Patel VI, Judelson DR, et al. Outcomes of lower extremity bypass performedfor acute limb ischemia. Journal of Vascular Surgery. 2013;58(4):949-956.
5.
-arm trial of endovascularmechanical debulking as initial therapy in patients with acute and subacute lower limb
ischemia: One-year outcomes. Journal of Endovascular Therapy. 2019;26(3):291-301.
6. Penumbra Inc.A Report on the Study entitled CLP-25269: A Subset Analysis of thePRISM Trial in Patients with Acute Limb Ischemia.2022.
7. Ebben HP, Jongkind V, Wisselink W, Hoksbergen AWJ, Yeung KK. Catheter DirectedThrombolysis Protocols for Peripheral Arterial Occlusions: a Systematic Review. European journal of vascular and endovascular surgery : the official journal of the European
Society for Vascular Surgery. 2019;57(5):667-675.
8. Tang Q-H, Chen J, Hu C-F, Zhang X-L. Comparison between endovascular and open
surgery for the treatment of peripheral artery diseases: a meta-analysis. Annals of Vascular Surgery. 2020;62:484-495.
9. Rossi M, Tipaldi MA, Tagliaferro FB, et al. Aspiration Thrombectomy with the Indigo
System for Acute Lower Limb Ischemia: Preliminary experience and analysis of parameters affecting the outcome. Annals of vascular surgery. 2021;76:426-435.
10. Lopez R, Yamashita TS, Neisen M, et al. Single-center experience with Indigo aspiration
thrombectomy for acute lower limb ischemia. Journal of vascular surgery.
2020;72(1):226-232.
11. Teter K, Arko F, Muck P, et al. Aspiration thrombectomy for the management of acutedeep venous thrombosis in the setting of venous thoracic outlet syndrome. Vascular.
2020;28(2):183-188.
12. Piacentino F, Coppola A, Zaghetto A, et al. Vacuum-assisted mechanical thrombectomy
in extensively occlusive thrombosis of dialysis arteriovenous grafts with indigo system.
Journal of Vascular Access. 2020;21(5):673-679.
SMA

1. Huasen B, Massmann A, Bisdas T, et al. Multi-center registry for vacuum-assisted
thrombectomy of acute superior mesenteric artery thrombosis. J Clin Case Stud Rev.
2021.
2. TBisdas T, Stavroulakis K, et al. Initial Experience With the 6-F and 8-F Indigo Thrombectomy System for Acute Renovisceral Occlusive Events
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3. Garzelli L, Iannis B. Abdallah , et al. Endovascular Thrombectomy for Acute Arterial
Mesenteric Ischaemia: No Benefit of Mechanical Over Manual Thrombus Aspiration
4. de Donato G, Pasqui E, Sponza M, et al. Safety and efficacy of vacuum assisted thromboaspiration in patients with acute lower limb ischaemia: The INDIAN trial. European
Journal of Vascular and Endovascular Surgery. 2021.
5. Rossi M, Tipaldi MA, Tagliaferro FB, et al. Aspiration Thrombectomy with the Indigo
System for Acute Lower Limb Ischemia: Preliminary experience and analysis of parameters affecting the outcome. Annals of vascular surgery. 2021;76:426-435.
6. Lopez R, Yamashita TS, Neisen M, et al. Single-center experience with Indigo aspiration
thrombectomy for acute lower limb ischemia. Journal of vascular surgery.
2020;72(1):226-232.
7. Teter K, Arko F, Muck P, et al. Aspiration thrombectomy for the management of acutedeep venous thrombosis in the setting of venous thoracic outlet syndrome. Vascular.
2020;28(2):183-188.
8. Piacentino F, Coppola A, Zaghetto A, et al. Vacuum-assisted mechanical thrombectomy
in extensively occlusive thrombosis of dialysis arteriovenous grafts with indigo system.
Journal of Vascular Access. 2020;21(5):673-679.

DVT

1. Broderick C, Watson L, Armon MP. Thrombolytic strategies versus standard anticoagulation for acute deep vein thrombosis of the lower limb. The Cochrane database of systematic reviews. 2021;1:Cd002783.
2. Rodríguez LE, Aboukheir-Aboukheir A, Figueroa-Vicente R, et al. Hybrid operative
thrombectomy is noninferior to percutaneous techniques for the treatment of acute iliofemoral deep venous thrombosis. Journal of Vascular Surgery: Venous and LymphaticDisorders. 2017;5(2):177-184.
3. Lichtenberg M, Stahlhoff WF, Özkapi A, de Graaf R, Breuckmann F. Safety, procedural
success and outcome of the Aspirex S endovascular thrombectomy system in the treatment of iliofemoral deep vein thrombosis Data from the Arnsberg Aspirex Registry.
Vasa - European Journal of Vascular Medicine. 2019;48(4):341-346.
4. Huasen B, Khan A, Suwathep P, Beropoulis E, Bisdas T. Initial experience of aspiration
thrombectomy using the Indigo Aspiration System for acute iliofemoral deep veinthrombosis. J Clin Case Stud Rev. 2021.
5. Lopez R, DeMartino R, Fleming M, Bjarnason H, Neisen M. Aspiration thrombectomy
for acute iliofemoral or central deep venous thrombosis. Journal of Vascular Surgery:
Venous and Lymphatic Disorders. 2019;7(2):162-168.
6. Teter K, Arko F, Muck P, et al. Aspiration thrombectomy for the management of acutedeep venous thrombosis in the setting of venous thoracic outlet syndrome. Vascular.
2020;28(2):183-188.
7. Abraham B, Sedhom R, Megaly MS, et al. Outcomes of catheter-directed thrombolysis
versus anticoagulation alone in patients with acute deep venous thrombosis, a systematicreview and meta-analysis. Catheterization and Cardiovascular Interventions.
2020;95:S96-S97.
8. Robertson B, Neville E, Muck A, et al. Technical success and short-term results frommechanical thrombectomy for lower extremity iliofemoral deep vein thrombosis using a
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computer aided mechanical aspiration thrombectomy device. Journal of Vascular Surgery: Venous and Lymphatic Disorders. 2022;10(3):594-601.
9. Lichtenberg M. Endovascular mechanical thrombectomy versus thrombolysis only in patients with iliofemoral deep vein thrombosis- A systematic review and meta-analysis.
Vasa - European Journal of Vascular Medicine. 2020;49(SUPPL 105):20-21.
10. Food and Drug Administration. ClotTriever Thrombectomy System. 2020;
https://www.accessdata.fda.gov/cdrh_docs/pdf19/K193462.pdf. Accessed November 11,2020.
11. Hölper P, Kotelis D, Attigah N, Hyhlik-Dürr A, Böckler D. Longterm results after surgical thrombectomy and simultaneous stenting for symptomatic iliofemoral venous thrombosis. European Journal of Vascular and Endovascular Surgery. 2010;39(3):349-355.
12. Qato K. Penumbra Inc. Ilio-Femoral DVT, Virtual DVT Program. 2022.
13. Rotolo P. Penumbra Inc. Reocclusion: Is the there a problem? National VTE Summit.
2022.
14. Salem KM, Saadeddin Z, Go C, et al. Risk factors for acute kidney injury after pharmacomechanical thrombolysis for acute deep vein thrombosis. Journal of Vascular Surgery:
Venous and Lymphatic Disorders. 2021;9(4):868-873.

Penumbra, Inc.

Penumbra, Inc