Novel Concept Regenerative, Immune-Privileged, Bio-Stentgraft
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1 Novel Concept Regenerative, Immune-Privileged, Bio-Stentgraft Bruce M. Gordon, DO, FACC Advanced Heart Care, PA The Heart Hospital Baylor Plano, Texas Director, Cardiac Catheterization Lab, Denton, TX The Heart Hospital Baylor Denton
2 Disclosures Consultant: Medtronic Peytant Solutions Stockholder: Palmaz Scientific Scientia Cardio Access Total Wire 2
3 All Stents Elicit Foreign Bodies Reaction (FBR) FOREIGN BODIES Metal/Alloy (Nitinol, Sst., Chromium, Platinum) Synthetics Covering (Teflon, Dacron, Silicone, Urethane) Drug Carrier Coating (Urethane, Silicone) Pharmaceuticals (Paclitaxel, Rapamycin) Xenografts (Bovine, Porcine, Ovine, Equine - GVHD REACTIONS Inflammation Scar Tissue Thrombosis Restenosis Infection Allergic Migration Delamination 3
4 Regenerative Human Biomaterial - Amnion >100 years of Clinical Experience OP, Wound Repair, Surgery, Spine, Ob/Gyn, PD Immune-Privileged: Histocompatible antigens, survives in a hostile environments Anti-Thrombotic: PGI2/Anti-phospholipase-A2 peptides Anti-Inflammatory: tryptophan desert amino acid is depleted and inhibits lymphocyte proliferation Anti-Fibrosis/Anti-Scarring: contains tissue inhibitors regulate many crucial processes in inflammation and fibrotic processes 4
5 Regenerative Human Biomaterial Amnion (Cont.) Anti-Microbial: Human β3-defensin (HBD), peptides resists microbial colonization Non-Tumorigenic: AM-derived cellular cytokine solution (ACCS), a secreted product AM Multipotent Progenitor (AMP) cells Pro-Apoptosis: expresses active caspase-3 (cysteine peptidase) Compliant & Durable: AM structure & biological viability make it ideal for creating scaffolds use Tissue Engineering Readily Available: only living human sourced natural polymeric biomedical material obtained, issue free 5
6 Amnion as a Vascular Substitute Longitudinal Section of Amnion 5 & 48 wk Ovine Trials Human amnion - xenograft implants Juvenile ovine models Conduit external jugular Proximal & distal end-to-end anastomosis Longitudinal seam Results Demonstrated complete patency Normal endothelialization Without: Stenosis, Fibrosis, Intimal Thickening Thrombus Aneurysm, Leaks, Perforation Infections Inflammation, Foreign Body Rejection Properties of the Human Amnion for Potential use in Tissue Engineering; Niknejad H, et al.; European Cells and Materials Vo Discussion with Reviewers, pg Implantation of Amniotic Membrane as a Vascular Substitute in the External Jugular Vein of Juvenile Sheep, Niknejad H, et al, J Vasc. Surg. ;56(4): doi: /j.jvs
7 Amnion Applied to Stents Applications: Vascular, pulmonary, GI, etc. Superior engraftment: Immuneprivileged graft covering stent cells Facilitates endovascular healing: promotes endothelium, antiinflammatory Low profile: ~25 micron Versatile: Alloy & bio-absorbable scaffolding, catheter delivery FDA Status: Investigational device AmnioStent Peytant Solutions, Inc. Minneapolis, MN 7
8 POC Endovascular - Amnion Stent Graft AMNIOSTENT TRIAL Proximal & Distal Gross Pathology AmnioStent Ovine model Ilio-femoral artery Amnion covered, SE alloy stent Artery pre-conditioned prior to implant Low & High Magnified Cross Sections of AmnioStent RESULTS Fully patent Quiet - no thrombus, No scar tissue Healed & Bio-integrated Re-endothelialized Barrier to transmigrating neutrophils No infections No device migration 8
9 Amnion Covered Stent - Airway POC AMNION COVERED STENT TRIAL Ovine Models Amnion covered, alloy stents Trachea implants Proximal & Distal Gross Pathology Amnion Covered Stent AMNION RESULTS Cross section of Amnion Covered Stent Fully Patent Re-epithelialization Functional Ciliated Epithelium Mucociliary Escalator (MCE) Healed/Bio-Integrated No Inflammation, No Granuloma No Infections No Migration Preservation of normal architecture Barrier to transmigrating neutrophils 9
10 Summary Amniotic membrane a natural 1 solution to foreign body response Amniotic membrane is a promising development as a graft combined with a catheter delivered scaffolding Permanent: alloy AmnioStent Non-permanent: bio-absorbable AmnioStent 1 Simple solution - Occam s Razor 10
11 Thank You
12 Novel Concept Regenerative, Immune-Privileged, Bio-Stentgraft Bruce M. Gordon, DO, FACC Advanced Heart Care, PA The Heart Hospital Baylor Plano, Texas Director, Cardiac Catheterization Lab, Denton, TX The Heart Hospital Baylor Denton
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