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The Endospan Solution for AAA
Jacob Cynamon, MD Department of Radiology Montefiore Medical Center/ AECOM CRT 2012
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The Problem EVAR and TEVAR in patients with small, tortuous iliac arteries Simple design and deployment devices are not available No Truly Percutaneous Solution
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The Solution Trivascular- Ovation Device CE mark
U.S. Humanitarian Device Exemption Approval 14 Fr OD Delivery for small tortuous iliac arteries
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The Solution Endospan- Horizon
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Horizon – AAA Stent Graft
True 14 Fr. OD hydrophilic coated delivery system One-sided percutaneous Proximal and distal anatomical fixation No cannulation of the contralateral limb needed Simple and intuitive sequential implantation steps
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Endospan Founded in ’09 Venture backed, based in Israel.
Simpler, more Intuitive solutions for treating Aneurysms Three Endograft Programs - Clinical Phase During 2012
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Active Endograft Programs
AAA - Horizon™ J/PRAA - Honest™ Arch TAA - Nexus™
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“Out of the Box” Design = Low Crossing Profile
Innovative serial component design leads to dramatic reduction in crossing profile
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Horizon – Video
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Deployment in a bovine aorta
Horizon – In-Vivo Deployment in a bovine aorta
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R&D Process: From Concept to Patient
Numerical model building Fluid dynamics testing Fatigue/durability simulator designed and built 400,000,000 cycles durability test performed
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Elaborate Testing Methodology
Testing under axial and radial loading conditions Full 400 M cycles completed in 6wks Real-life pulsatile regimen Worst-case hypertensive scenarios Proprietary methodology & testers (patent pending)
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Horizon™ – Clinical Plans
Human studies to commence Q2 ’12 Main European study sites – Dusseldorf , Zurich and Modena (Prof.’s Kolvenbach, Lachat, Coppi) 20 patient feasibility study Subsequently commencing EU registration study for CE Mark
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Honest™ – Hostile Neck Stent Graft
What are the goals? A real “off-the-shelf” product Quick turnaround diagnosis - treatment Low crossing profile Easy branch cannulation Reasonable pricing
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Honest™ – J/PRAA Stent Graft
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Horizon™ & Honest™ Timelines
Horizon - EU Q1’ Q2’ Q1‘ Q2-Q4’ Q1’ Q4’13 Regulatory Strategy Prepared Binding Approval by Notified Body IRB Submission to IRB (& MoHs) FIM Study CE Registration Study CE Mark Granted Honest - EU Q4’ Q1,Q2’12 Jun.‘ Q3,Q4’ Q1’ Q3’13 Design Input; Reg. Strategy Prepared R&D->V&V; Approval of Reg. Strategy. IRB Submission to IRB (& MoHs) FIM Study CE Registration Study CE Mark Granted Honest - US Q3’ Q1’ Q4’14 Pre IDE Meeting IDE Pivotal Study PMA Submission
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Deployment in a silicone phantom
Nexus Deployment in a silicone phantom
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Nexus™ Timelines EU US Q1’12 Mid.’12 Q3,Q4‘12 Q1’13 Q2’13
Reg. Strategy approved by Notified Body IRB Submission to IRB (& MoHs) FIM/Registration Study CE Mark Application CE Mark Granted US Q1’ Mid.’ Q3,Q4‘ Q1’ Q2’13 HUD Designation Filed; Approved Pre IDE Meeting Setting-Up IDE Sites HDE Submission HDE Approved; Market Launch
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Conclusions Solutions for low profile EVAR and TEVAR are in the Pipeline 14 Fr fully percutaneous devices will be available (I predict) Endospan’s novel approach to AAA and TAA repair needs safety and efficacy validation The future is bright
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