TRAINING DOCUMENT, FOR INTERNAL USE ONLY. Pre-case Planning

Transcription

1 TRINING DOCUMENT, FOR INTERNL USE ONLY Pre-case Planning

2 Imaging Specifications CONTRST ENHNCED CT-SCN CT angiography date should be within 3 months of implant date CT slices thickness not exceeding 3 mm t discharge (if applicable) and for all further follow up visits it is recommended to have CT slices of no more than 3 mm 2-VIEW (-P & LTERL) DOMINL X-RY Include the entire portion of stent covered aorta Ensure that all devices are visible in each view recorded For follow-up visits, perform the same views

3 Indication For Use ENDURNT STENT GRFT SYSTEM IS INDICTED FOR ENDOVSCULR TRETMENT OF INFRRENL DOMINL ORTIC OR ORTO-ILIC NEURYSMS HVING: dequate iliac/femoral access : 6.7 mm vessel diameter for ipsilateral side, 5 mm vessel diameter for contralateral side. neurysms with proximal neck diameters of mm: Proximal necks 10 mm in length with non-significant calcification, and/or non-significant thrombus with < 60 infrarenal and <45 suprarenal angulation and a vessel diameter approximately 10-20% smaller than the labeled Endurant Stent diameter Proximal necks 15 mm neck with non-significant calcification, and/or non-significant thrombus with <75 infrarenal and <60 suprarenal angulation and a vessel diameter approximately 10-20% smaller than the labeled Endurant Stent diameter Iliac diameters of 8-25 mm Morphology suitable for endovascular repair Distal fixation length of >15 mm

4 Neck ngulations L1 α β D1a D1b α ngle between the suprarenal aorta and the neck ( < 45 ) β ngle between the neck and aneurysm angle ( < 60 ) L1 of the nonaneurysmal aortic neck (distance between D1a and D1b) > 1.0 cm L1 α D1a β D1b α ngle between the suprarenal aorta and the neck (>45 and <60 ) β ngle between the neck and aneurysm angle (>60 and <75 ) L1 of the nonaneurysmal aortic neck (distance between D1a and D1b) > 1.5 cm

5 bdominal orta Measurements

6 Stent Over Sizing Guidelines Mainbody: ifurcated, orto-uni-iliac (UI), ortic Extension, bdominal Tube Native ortic Vessel mm mm mm mm mm Suggested Endurant 23 mm 25 mm 28 mm 32 mm 36 mm Limb: Ipsilateral Limb, Contralateral Limb, Iliac Extension Native Iliac Vessel 8-9 mm mm mm mm mm mm Suggested Endurant 10 mm 13 mm 16 mm 20 mm 24 mm 28 mm

7 Component Placement Guide Multiple Options for Patient Customization UI STENT GRFT IFURCTED MINODY *Measurements for 120mm length bifurcated stent graft. Measurements for 23mm diameter bifurcated stent graft

8 Endurant Product Code Proximal diameter (mm) Distal diameter (mm) covered length (mm) EN F C 120 E E Product name Proximal Design F FreeFlo W Open web Distal Design C Closed web Region E Europe & ROW Device Configuration ifurcated L Contralateral iliac limb E Iliac Extension C ortic Extension (Cuff) T bdominal Tube U orto-uni-iliac Delivery System E Endurant Delivery System

9 vailable Stent s Configuration (Catalogue) (Manufactured) ifurcated 120mm, 145mm, 170mm 124mm, 145mm, 166mm Contralateral Limb 80mm, 95mm, 120mm 82mm, 93mm, 124mm Iliac Extension 80mm 82mm ortic Extension 45mm 49mm orto-uni-iliac 105mm 102mm bdominal Tube 70mm 70mm Minimum overlapping required for extensions: 3 stents Recommendation: use central lumen line for length calculation; if not available, please plan for additional extentions.

10 Stent Dimension ifurcated Straight Limb Proximal Proximal Distal C D D Distal C Measurements in mm

11 Stent Dimension ifurcated Flared Limb Proximal Proximal Distal C D E F C D E F Distal Measurements in mm

12 Stent Dimension - Contralateral Limbs - Tapered Limb Proximal Proximal Distal Distal Measurements in mm

13 Stent Dimension - Contralateral Limbs - Straight Limb Proximal Proximal Distal Measurements in mm Distal

14 Stent Dimension - Contralateral Limbs - Flared Limb Flared Limb Proximal Proximal Distal Distal Measurements in mm

15 Stent Dimension - orto-uni-iliac Proximal Proximal Distal Measurements in mm Distal