First in Human Experience with the Gore Conformable Excluder Endoprosthesis
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- Cecil Bradford
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1 A new conformable abdominal endovascular device First in Human Experience with the Gore Conformable Excluder Endoprosthesis Robert Y. Rhee, MD Chief, Vascular and Endovascular Surgery Director, Maimonides Aortic Center Maimonides Medical Center Brooklyn, New York LINC 2018
2 Disclosures WL Gore: Consultant, PI clinical trial, Research Grants Medtronic: Research Grants Cook: Research Grants Boston Scientific: Consultant, MAB, Research Grants GE Healthcare: Consultant
3 A new conformable endovascular abdominal device
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5 GORE EXCLUDER Conformable AAA Endoprosthesis with ACTIVE CONTROL 16 Fr for most trunks Proximal Fixation Ability to conform to proximal neck angles up to 90 Achieve seal in short ( 10 mm) proximal necks Ability to reposition the device Mechanism to adjust device angulation Refine and customize placement Orthogonal positioning
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7 First in Human CEXC case patient A.I.
8 Patient 77 yo male Retired machine craftsman Immigrated to Brooklyn 15 years ago from Odessa, Ukraine Family history of sudden death, possible aneurysm rupture Rapid growth AAA ( cm) Severe anxiety due to AAA
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11 Deployment
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17 day Follow-up Caution: Investigational Device. Limited by United States Law to Investigational Use Only.
18 day Follow-up Caution: Investigational Device. Limited by United States Law to Investigational Use Only.
19 Data Point Procedure Time Estimated Blood Loss Fluoro Time Contrast Procedural Comments Procedural observations? Value 68 min 20 ml 18 min 46 ml Repos 2x, Angulated 1x N/A Technical Success Yes 100% Investigator Feedback impressed with device ability to conform to calcium in the proximal neck GIS PSF Support Feedback Same as physician. Diameter (mm) Angle 13 Max AAA diameter (mm) 44.9 Neck Length (mm) 10+ Device Implanted CXT261212C (CEXC Trunk) 1 contra, 2 Dryseal Flex, 1 iliac extender
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21 2 nd Patient
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24 Data Point Procedure Time Estimated Blood Loss Fluoro Time Value 91 min 30 ml 24 min Contrast 36 Procedural Comments Procedural observations? 1x Angulation (A/P), 1x Reposition Possible Type II, widely patent IMA Technical Success Yes 100% GIS PSF Diameter (mm) Angle 29 Max AAA diameter (mm) 43.2 Neck Length (mm) 10+ Investigator Feedback Support Feedback Device Implanted CXT231216C 1 contra, 2 DrySeal Flex Extremely positive about ability to place device in an angled/orthogaonal position Straightforward, performed as expected
25 Prospective, non-randomized, US IDE study 50 U.S. sites 6 patients enrolled so far Substudy: Short Neck Proximal neck angle: 60 Proximal seal length: 10 mm 80 subjects Substudy: High Neck Angulation Proximal neck angle: > 60 and 90 Proximal seal length: 10 mm 110 subjects Caution: Investigational Device. Limited by United States Law to Investigational Use Only.
26 Summary First in human performed 19, December 2017 FIH 30 day follow-up unremarkable 5 additional trial patients successfully treated 10 mm - 90 degree high neck angle study started screening Expect EU limited release with registry in 3-4 months
Challenges with Complex Anatomies Advancing Care in Endovascular Aortic Treatment
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