Gelweave - Terumo Cardiovascular Systems

1 Gelweave Branched Grafts with Radiopaque Markers Suitable for Debranching and Associated Hybrid Procedures23 Branched Grafts with Radiopaque Markers Suitable for Debranching and Associated Hybrid Procedures The use of side branch grafts is intended to facilitate the delivery of endovascular devices in high risk surgical patients 1 Side branch grafts may be used in the treatment of thoracic and thoracoabdominal aneurysms 1,2 Debranching and hybrid procedures of complex thoracic and thoracoabdominal aneurysms expand the field of endovascular stent grafting in high risk surgical patients 3,5 Although open surgical repair remains the gold standard treatment for fit patients, hybrid procedures including debranching of the arch vessels for aortic arch pathology followed by completion of the endovascular procedure are feasible in selected high surgical risk patients 4 The use of hybrid procedures provides an alternative to open repair in high risk surgical patients with complex aortic pathology 3,4,5 Patented radiopaque marker designs 6 The radiopaque markers - improve in vivo visualization 7 - facilitate precise stent graft positioning 8 Overall, the literature concludes that these procedures provide a therapeutic alternative to patients who would be otherwise inoperable.

2 14 Designed in association with Giampiero Esposito, MD, Chief of Cardiovascular Surgery Department, Santa Maria Hospital, Bari, Size Length Bore Size Length (mm) (cm) (mm) (cm) Catalogue Branches 20 40 22 40 24 40 26 40 28 40 30 40 32 40 34 40 A B C D 10 10 8 10 10 10 8 10 10 10 8 10 10 10 8 10 10 10 8 10 10 10 8 1010 10 8 10 10 10 8 10 734020CX4 RMS734022CX4 RMS734024CX4 RMS734026CX4 RMS734028CX4 RMS734030CX4 RMS734032CX4 RMS734034CX4 RMS A B C D 40 30 30 30 40 30 30 30 40 30 30 30 40 30 30 30 40 30 30 30 40 30 30 30 40 30 30 30 40 30 30 30 Patented radiopaque marker designBrachiocephalic trunk branchLeft common carotidartery branchLeft subclavian artery, perfusion side branch or endovascular system delivery branchLeft subclavian artery or bypass to the visceral arteriesAortic arch sectionABCD30oLupiae Branched Graft5 Examples of Completed Debranching Hybrid ProceduresAscending aorta.

3 Arch & descending aortic aneurysmSupra-renal thoracoabdominal aortic aneurysm involving the ascending aortaRadiopaque markers improve in vivo visualization6 Branched Arch Graft with RadiopaqueMarkersDesigned in association with Joseph E Bavaria, MD, Professor of Surgery and Director of the thoracic Aortic Surgery Program, University of Pennsylvania, Philadelphia, PA. Bore Sizes Usable Lengths Catalogue (mm) (cm) No. A B C D E A B C D E 22 10 12 8 8 20 30 15 15 30 732022CX4RM 24 10 12 8 8 20 30 15 15 30 732024CX4RM 26 10 12 8 8 20 30 15 15 30 732026CX4RM 28 10 12 8 8 20 30 15 15 30 732028CX4RM 30 10 12 8 8 20 30 15 15 30 732030CX4RM 32 10 12 8 8 20 30 15 15 30 732032CX4RM 34 10 12 8 8 20 30 15 15 30 732034CX4 RMA20o20o45oBCDE Left subclavian artery branchLeft common carotidartery branchBrachiocephalic trunk branchPerfusion/endovascular system delivery branchAortic arch sectionRadiopaque markers x2= radiopaque marker7 thoracic Arch Graft with Radiopaque MarkerDesigned in association with G.

4 Chad Hughes, MD, Assistant Professor of Surgery, Director of the thoracic Aortic Surgery Program, Section of Cardiovascular & thoracic Surgery, Duke University Medical Center, Durham, NC. Bore Sizes Usable Lengths Catalogue (mm) (cm) No. A B C A B C 12 10 8 22 25 13 732212/10/8 CRM 14 10 10 22 25 13 732214/10/10 CRMA20oBC100o Joins to aortic archBrachiocephalic trunk branchLeft common carotid artery branchPerfusion/endovascular system delivery branchRadiopaque marker= radiopaque marker 8 Thoracoabdominal Graft with Radiopaque MarkersC45o45oBAF45o45oDENote: Branch B offset at 45o to section A. Radiopaque marker underneath branch. Celiac axisOversewnSuperior mesenteric arteryLeft renal arteryRight renal arteryJoins to iliac arteryPerfusion/endovascular system delivery branch (removed and oversewn after introduction of the endovascular graft)Radiopaque markers x9= radiopaque marker9 Designed in association with ~ G.

5 Chad Hughes, MD, Assistant Professor of Surgery, Director of the thoracic Aortic Surgery Program, Section of Cardiovascular & thoracic Surgery, Duke University Medical Center, Durham, L. McCann, MD, Professor of Surgery, Division of General Surgery, Vascular Surgery, Duke University Medical Center, Durham, of a Completed Abdominal Debranching and Thoracoabdominal Hybrid ProcedureEndovascular graftCeliac axisRight renal arterySuperior mesenteric arteryLeft renal arteryIliac arteryIllustration from Hughes GC. et al. 9 Bore Sizes Usable Lengths Catalogue (mm) (cm) No. A B C D E F A B C D E F 14 10 8 8 6 6 25 25 25 25 25 25 7314886/6/10 BRM 14 10 8 8 8 8 25 25 25 25 25 25 7314888/8/10 BRM 10 Perfusion/endovascular system delivery branchJoins to aortic arch, abdominal aorta or iliac arteryAortic arch or renal/visceral artery branchesRadiopaque markerTrifurcate with Side Branch and Radiopaque MarkerDesigned in association with Giampaolo Zoffoli, MD, Department of Cardiovascular Surgery, Ospedale dell Angelo, Venice, : Branch B offset at 30o to section CAE 25o Bore Sizes Usable Lengths Catalogue (mm) (cm) No.

6 A B C D E A B C D E 12 10 10 6 6 15 15 30 30 30 731206/10/10RM 14 10 10 7 7 15 15 30 30 30 731407/10/10RM 16 10 10 8 8 15 15 30 30 30 731608/10/10RM16 10 8 8 8 15 15 30 30 30 731608/8/10RM= radiopaque marker11 References1. Lumsden AB. et al. (2007). Hybrid Interventions for Complex Aortic Pathology. Endovascular Today, November; 80 Black SA. et al. (2006). Complex Thoracoabdominal Aortic Aneurysms: Endovascular Exclusion with Visceral Revascularization. Journal of Vascular Surgery, Vol. 43, No. 6;1081 Zhou W et al. (2006). Hybrid Approach to Complex thoracic Aortic Aneurysms in High-risk Patients: Surgical Challenges and Clinical Outcomes. Journal of Vascular Surgery, Vol. 44, No. 4; 688 Chiesa R. et al. (2008). Endovascular Treatment of Aortic Arch Aneurysms.

7 Jornal Vascular Brasileiro, Vol. 7, No. 2; 90 Milewski RK. et al. (2010). Have Hybrid Procedures Replaced Open Aortic Arch Reconstruction in High Risk Patients? A Comparative Study of Elective Open Arch Debranching with Endovascular Stent Graft Placement and Conventional Elective Open Total and Distal Aortic Arch Reconstruction. The Journal of thoracic and Cardiovascular Surgery, Vol. 140, No. 3; 590 European Patent Number: Carroccio A et al. (2005). Aortic Arch and Descending thoracic Aortic Aneurysms: Experience with Stent Grafting for Second-Stage Elephant Trunk Repair. Vascular, Vol. 13, No. 1; 5 Data on file at Vascutek Hughes GC. et al. (2011). Pan-aortic Hybrid Treatment of Mega-aorta Syndrome. Journal of Vascular Surgery, Vol. 53, No. 5; papers available on request from Vascutek by:VASCUTEK, a Terumo CompanyNewmains Avenue, InchinnanRenfrewshire PA4 9RR, Scotland, UKTel: (+44) 141 812 5555 Fax: (+44) 141 812 in the USA by: Terumo Cardiovascular Systems6200 Jackson RoadAnn Arbor MI 48103-9300 Customer Service: 888-758-8000 After Hours: 888-580-5058 Fax.