Coronary Stents Design        Part C – Biodegradable stents and        Future Solutions                                   ...
Biodegradable Stents (BDS)
Rational for Biodegradable stentsMetal stent drawbacks             Biodegradable stent advantages Cause permanent physica...
Design considerations   Overall time and rate of degradation       a very rapid degradation rate can be associated with ...
Igaki-Tamai BDS   A bioresorbable zigzag coil design   PLLA (Initial MW=183KDa)   Initial clinical trial results proved...
BVS (Abbott) Drug Eluting BDS   Drug: Everolimus   Base Polymer: PLLA   Coating: PDLLA   Releases 80% of its drug in 2...
Stent Functionality phasesRichard J Rapoza, PhD presented at the ICI meeting of 2009, Tel Aviv, Israel
REVA Drug Eluting BDS   Drug: Paclitaxel   Base polymer: Tyrosine-    derived polycarbonate platform   Low recoil (<1%)...
Absorbable Magnesium Stent(Medtronic)   Radial strength and recoil is    similar to BMS   4-month clinical results: late...
BDS Summary
New Concepts    Pro-healing approach    Drug eluting balloon
Endothelial Progenitor Cells Capture
Genous Stent   Precilinical trials       1 hour post- deployment:        90% cell coverage   1st Clinical trial    demo...
Drug eluting balloon                                      SeQuent® Please   Provides uniform drug dose   Reduces thrombo...
Core/shell fiber structure conceptI. Good mechanical propertiesII. Effective drug release profileIII. Porous structured co...
In-Vitro FTS Release           Effect of coating’s porosity      50/50 PDLGA                75/25 PDLGA            Porous ...
References   Amir Kraitzer, Yoel Kloog, Meital Zilberman, Approaches for    Prevention of Restenosis, J Biomed Mater Res ...
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Coronary Stent Deisgn Part C
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Coronary Stent Deisgn Part C

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Biodegradable Stents
Future Solutions

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Coronary Stent Deisgn Part C

  1. 1. Coronary Stents Design Part C – Biodegradable stents and Future Solutions Dr. Amir KraitzerThe contents of materials available on this presentation are reserved. Content may not be reproduced,published, or transferred except with the prior written permission of Dr. Amir Kraitzer
  2. 2. Biodegradable Stents (BDS)
  3. 3. Rational for Biodegradable stentsMetal stent drawbacks Biodegradable stent advantages Cause permanent physical  May eliminate early and late irritation complications of bare-metal Risk of long term endothelial stents  Restore the vasoreactivity dysfunction and chronic  Allow a gradual transfer of the inflammation Metal have thrombogenic mechanical load to the vessel  Higher capacity for drug properties incorporation and complex Inability for the vessel to release kinetics restore its a normal  Facilitate re-intervention physiology The need for a permanent prosthesis decreases dramatically 6 months post-implantation
  4. 4. Design considerations Overall time and rate of degradation  a very rapid degradation rate can be associated with inflammation Biocompatibility of degradation products to prevent toxicity Mechanical properties  Mechanical recoil  Strut size  Creep  Embolization of degraded particles Drug load Radiopacity
  5. 5. Igaki-Tamai BDS A bioresorbable zigzag coil design PLLA (Initial MW=183KDa) Initial clinical trial results proved efficacy and safety (2000) On November 2007 the stent obtained CE mark indicated for peripheral artery Igaki Tamai Stents loaded with ST638 (Tranilast) reduced neointima formation in animals
  6. 6. BVS (Abbott) Drug Eluting BDS Drug: Everolimus Base Polymer: PLLA Coating: PDLLA Releases 80% of its drug in 28 days Maintains radial strength for 3 months Mass loss after 6 months, complete resorption in two years Good clinical outcomes with two years follow-up No occurrence of thrombosis between 6 and 24 months Source: Abbott Vascular, AP2929018Rev A
  7. 7. Stent Functionality phasesRichard J Rapoza, PhD presented at the ICI meeting of 2009, Tel Aviv, Israel
  8. 8. REVA Drug Eluting BDS Drug: Paclitaxel Base polymer: Tyrosine- derived polycarbonate platform Low recoil (<1%) Slide and lock design Tunable resorption rate Radiopacity is achieved by the incorporation of iodine molecules
  9. 9. Absorbable Magnesium Stent(Medtronic) Radial strength and recoil is similar to BMS 4-month clinical results: late loss is comparable to BMS Further improvement in stent design due to:  Early recoil  Fast degradation  Neointima formation
  10. 10. BDS Summary
  11. 11. New Concepts  Pro-healing approach  Drug eluting balloon
  12. 12. Endothelial Progenitor Cells Capture
  13. 13. Genous Stent Precilinical trials  1 hour post- deployment: 90% cell coverage 1st Clinical trial demonstrated safety and feasibility 2nd Clinical trial demonstrated late loss is comparable to BMSEndothelial Progenitor Cell Capture by Stents Coated WithAntibody Against CD34 : The HEALING-FIM Registry, Aoki etal, J. Am. Coll. Cardiol. 2005;45;1574-1579
  14. 14. Drug eluting balloon SeQuent® Please Provides uniform drug dose Reduces thrombosis risk and enables shorter dual anti- platelet regimen Allows significantly lower drug dose compared with DES Two forms of release  Drug and spacer  Nanoparticles
  15. 15. Core/shell fiber structure conceptI. Good mechanical propertiesII. Effective drug release profileIII. Porous structured coating allows controlled release
  16. 16. In-Vitro FTS Release Effect of coating’s porosity 50/50 PDLGA 75/25 PDLGA Porous coating Porous coating Dense coating Dense coating
  17. 17. References Amir Kraitzer, Yoel Kloog, Meital Zilberman, Approaches for Prevention of Restenosis, J Biomed Mater Res Part B: Appl Biomater 85B: 583–603, 2008 Gladius Lewis, Review: Materials, Fluid Dynamics, and Solid Mechanics Aspects of Coronary Artery Stents: A State-of-the-Art Review, Biomed Mater Res Part B: Appl Biomater 86B: 569–590, 2008 Meital Zilberman, Amir Kraitzer, Orly Grinberg and Jonathan J. Elsner, Drug-Eluting Medical Implants, In : Handbook of European Pharmacology, 2008 Update on Bioabsorbable Stents: From Bench to Clinical, RON WAKSMAN, Journal of Interventional Cardiology, Vol. 19, No. 5, 2006
  18. 18. Thank you

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