Gelweave TM. Thoracic and Thoracoabdominal Graft Geometries. Ante-Flo TM 4 Branch Plexus. Siena Valsalva TM Trifurcate Arch Graft. Coselli.

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1 Gelweave TM Thoracic and Thoracoabdominal Graft Geometries Ante-Flo TM 4 Branch Plexus Siena Valsalva TM Trifurcate Arch Graft Coselli Lupiae Product availability subject to local regulatory approval.

2 Contents Page Ante-Flo TM & Extra Length Ante-Flo TM with Offset Branch 2 Pre-curved Graft & Pre-curved Ante-Flo TM 3 Gelweave TM Plexus 4 Gelweave TM Siena Collared Grafts with Radiopaque Markers 5 Gelweave TM Valsalva 6 Gelweave TM Trifurcate Arch Graft 7 Gelweave TM Coselli Thoracoabdominal Graft 8 Gelweave TM Thoracoabdominal Trifurcate Graft 9 Gelweave TM Lupiae For more information visit: -1-

3 Ante-Flo TM & Extra Length Ante-Flo TM with Offset Branch Aortic Arch Applications Antegrade flow made easy by the side branch for, - minimised circulatory arrest time and earlier patient re-warming 1 - lower risk of neurological deficits 2 - reduced chance of perfusing aortic false lumen 1 Convenience and graft integrity maintained Aortic Arch Repair Standard Ante-Flo TM applications and left subclavian artery repair. Bore Size Usable Length Bore Size Usable Length Bore Size 40 x 40 x 40 x 40 x 40 x 40 x 40 x 40 x 70/8 70/8 70/8 70/8 70/8 70/8 70/8 70/8 72/8S 73/8S 73/8S 73/8S 73/8S 73/8S Perfusion side branch diameter 8. Also available with, 1. cm usable length body section - Cat Nos. 70/8 to 70/8. 2. diameter perfusion side branch - Cat Nos. 70/ to 70/ & 70/ to 70/. 1. Perfusion side branch diameter Body and perfusion side branch usable lengths cm and cm respectively. -2-

4 Pre-curved Graft & Pre-curved Ante-Flo TM Aortic Arch Repair Unique pre-curved design Designed to closely match aortic arch anatomy Potential for reduced kinking Aortic Arch Applications Additional features and benefits to that of the standard Ante-Flo TM Unique pre-curved design Designed to closely match aortic arch anatomy Potential for reduced kinking Bore Size Bore Size Bore Size Bore Size 72ST 73ST 73ST 73ST 73ST 73ST 73ST 72ST/8A 73ST/8A 73ST/8A 73ST/8A 73ST/8A 73ST/8A 73ST/8A Product usable length cm 1. Perfusion side branch diameter Body and perfusion side branch usable lengths cm and cm respectively. -3-

5 Gelweave TM Plexus Aortic Arch Replacement 3 or 4 branch designs Antegrade flow made easy by the perfusion side branch may offer, - reduced incidence of temporary neurological deficits 3 - preventive effect against embolic stroke 3 - potential for reduced operating time 4 Convenience and graft integrity maintained 3 Branch 4 Branch Bore Size Bore Bore Size Size Cat No /8 7288/8 7388/8 7388/8 7388/8 7388/8 7388/8 7388/8 1. Body and branch usable lengths 40cm and cm respectively. 2. Arch branch diameters x 8 x 8. Perfusion side branch diameter Also available with a diameter side branch - Cat Nos. 7088/ to 7388/. -4-

6 Gelweave TM Siena Collared Grafts with Radiopaque Markers Aortic Arch Applications Primarily indicated for first stage elephant trunk procedures Radiopaque markers facilitate second stage endovascular repair The collar compensates for diameter mismatch between distal aorta and graft, reducing tension on the distal anastomosis and potential for aneurysm rupture before second stage repair 5 Side branch permits antegrade perfusion Gelweave TM Siena Straight Gelweave TM Siena Ante-Flo Gelweave TM Siena 4 Branch Plexus Bore Usable Size Length cm Bore Usable Size Length cm Bore Usable Size Length cm 70RM 72RM 73RM 73RM 73RM 73RM 73RM 73RM 70/8RM 72/8RM 73/8RM 73/8RM 73/8RM 73/8RM 73/8RM 73/8RM 7088/8RM 7288/8RM 7388/8RM 7388/8RM 7388/8RM 7388/8RM 7388/8RM 7388/8RM 1. Perfusion side branch - bore size 8 - length cm 2. Also available with a perfusion branch - Cat Nos. 70/RM - 73/RM 1. Branches - bore sizes x 8 x 8 - length cm 2. Perfusion side branch offset at o in a horizontal plane to the body of the graft - bore size 8 - length cm 3. Also available with a perfusion side branch - Cat Nos. 7088/RM /RM For all designs: 1. Product usable length cm. Graft proximal end to collar cm. Collar to graft distal end cm. 2. Relaxed distance between the radiopaque markers 2cm. -5-

7 Gelweave TM Valsalva Proximal Thoracic Aorta Replacement Aortic graft design for valve sparing or Bentall procedures Closely matches aortic root anatomy 6 Mimics natural response of the sinuses of Valsalva 7 Potential for, - increased valve leaflet longevity 8 - reduced tension on the coronary arteries 9 Bore Bore Size Size Maximum Skirt Usable Bore Length Size Skirt Cat Length No. Collar Bore Length Size Diameter cm ADP 7018ADP 70ADP 70ADP 70ADP 70ADP 70ADP 70ADP 70ADP 70ADP -6-

8 Gelweave TM Trifurcate Arch Graft Aortic Arch Applications Shortens hypothermic circulatory arrest times Minimises cerebral ischaemia 11 No touch technique - reduces the risk of embolisation 11 Minimises adverse outcomes Complements first stage elephant trunk repair Bore Size () Body Branches /8 x / x /8 x / x 2 1. Graft body usable length cm. 2. Branch usable length cm. -7-

9 Gelweave TM Coselli Thoracoabdominal Graft Thoracoabdominal Aortic Reconstruction Presewn integral side branches 12 Sequential artery reattachment and restoration of blood flow 13 Eliminates aortic patch pseudoaneurysm formation 13 No tension and early haemostasis 13 Bore Size Cat No. 708/8S4 728/8S4 738/8S4 738/8S4 738/8S4 738/8S4 1. Graft body usable length 60cm. 2. Branch dimensions, - upper pair (superior mesenteric & coeliac arteries) x cm - lower pair (renal arteries) 8 x cm -8-

10 Gelweave TM Thoracoabdominal Trifurcate Thoracoabdominal Aortic Reconstruction Sequential visceral and renal artery replacement 14 Allows for short visceral, renal and spinal ischaemic times 14 Offers low rates of end organ ischaemic damage and paraplegia 14 Bore Size Bore Cat Size No. () Bore Size Body Central Lateral Branch Branches / / /7 1. Graft body usable length 45cm. 2. Branch usable length cm. -9-

11 Gelweave TM Lupiae Debranching and Associated Hybrid Procedures Debranching graft design - facilitates creation of suitable landing zone,16 Radiopaque markers facilitate 2nd stage endovascular repair 16 Enables individual arch vessel reconstruction 17 The perfusion side branch minimises cardiopulmonary and circulatory arrest times Body Branches Bore Size Length Bore Size Length () (cm) () (cm) Catalogue No. 40 //8/ 40/// 70CX4RMS 40 //8/ 40/// 70CX4RMS 40 //8/ 40/// 70CX4RMS 40 //8/ 40/// 70CX4RMS 40 //8/ 40/// 70CX4RMS 40 //8/ 40/// 70CX4RMS 40 //8/ 40/// 70CX4RMS 40 //8/ 40/// 70CX4RMS 1. Graft body usable length 40cm. --

12 References 1. Havel M. et al. Operative Management of Aortic Aneurysms Using Profound Hypothermia & Circulatory Arrest. International Congress on Thoracic & Thoracoabdominal Aortic Aneurysm June 1994; Ehrlich M. et al. The Use of Profound Hypothermia and Circulatory Arrest in Operations on the Thoracic Aorta. European Journal of Cardiothoracic Surgery 1997; 11: Shiiya N. et al. Surgical Management of Atherosclerotic Aortic Arch Aneurysms Using Selective Cerebral Perfusion: 7-Year Experience in 52 Patients. European Journal of Cardiothoracic Surgery 00, 17: Adachi H et al. Usefulness of a New Branched Sealed Graft for the Replacement of the Aortic Arch. Japanese Journal for Artificial Organs 1997; 3: Neri E. et al. The Elephant Trunk Technique Made Easier. Ann Thorac Surg 04; 78: De Paulis R. et al. A New Aortic Dacron Conduit for Surgical Treatment of Aortic Root Pathology. Ital Heart J 00; 1 (7): De Paulis R. et al. Opening and Closing Characteristics of the Aortic Valve After Valve-Sparing Procedures Using a New Aortic Root Conduit. Ann Thorac Surg 01; 72: De Paulis R. et al. Analysis of Valve Motion After the Reimplantation Type of Valve-Sparing Procedure (David I) with a New Aortic Root Conduit. Ann Thorac Surg 02; 74: Luca Weltert, Ruggero De Paulis, Raffaele Scaffa, Daniele Maselli, Alessandro Bellisario and Stefano D Alessandro. Re-creation of a sinuslike graft expansion in Bentall procedure reduces stress at the coronary button anastomoses: A finite element study. Thorac Cardiovasc Surg 09;137: Strauch JT. et al. Technical Advances in Total Aortic Arch Replacement. Ann Thorac Surg 04; 77: Spielvogel D. et al. Aortic Arch Reconstruction Using a Trifurcated Graft. Ann Thorac Surg 03; 75: Personal Counication (Professor J S Coselli, 23 September 03). 13. Kokotsakis J. et al. Thoracoabdominal Aneurysm Repair using a Four-Branched Thoracoabdominal Graft: A Case Series. Cases Journal 09; 2: Ballard J. et al. Type III and IV Thoracoabdominal Aortic Aneurysm Repair: Results of a Trifurcate/Two Graft Technique. Journal of Vascular Surgery Vol 36, No. 2, August 02.. Marullo AGM et al. Hybrid Aortic Arch Debranching with Staged Endovascular Completion in DeBakey Type I Aortic Dissection. Ann Thorac Surg, 90: Esposito G et al. Mid-term Results of the Lupiae Technique in Patients with De Bakey Type I Acute Aortic Dissection. Eur J Cardio-Thoracic Surgery 12, Esposito G et al. Hybrid Repair of Type A Acute Aortic Dissections with the Lupiae Technique: Tenyear results. J Thoracic and Cardiovasc Surg, Vol 149, S99-S4. Clinical papers available on VASCUTEK Ltd Newmains Avenue, Inchinnan Renfrewshire PA4 9RR, Scotland, UK Tel: +44 (0) B127/5E

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