The Biocompatibility and Biostability of New Cardiovascular Materials and Devices

  • Ken Stokes
Part of the Biological and Medical Physics, Biomedical Engineering book series (BIOMEDICAL)


Evaluating a new material for use in an implantable device is a complicated business. ISO 14971 is designed to assist in determining device-risk assessment. ISO 10993 is intended to help steer one through the evaluation of materials for implantable devices. An FDA Guidance is available specifically for pacemaker leads, but may be helpful for other devices as well. However, completing a battery of in vitro and in vivo tests does not necessarily qualify a material for implant, because the in vivo environment cannot be duplicated in vitro. In vivo materials testing helps, but is still insufficient because the device may have its own issues. Device implants in animals may get one to human clinical studies and market release. Even after this stage, appropriate postmarket surveillance is necessary to know for sure how the device is really performing.


Implantable Device Potential Harmful Effect Pacemaker Lead Biocompatibility Testing Market Release 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


  1. 1.
    Williams D. (1990) Concise encyclopedia of medical and dental materials, 1st Ed. Pergamon Press, Oxford, UK.Google Scholar
  2. 2.
    Szycher M and Siciliano A. (1991) An assessment of 2,4 TDA formation from Surgitek polyurethane foam under simulated physiological conditions. J Biomater Appl 5:323–336.CrossRefGoogle Scholar
  3. 3.
    Hudson J and Crugnola A. (1987) The in vivo biodegradation of nylon 6 utilized in a particular IUD. J Biomater Appl 1:487–501.CrossRefGoogle Scholar
  4. 4.
    Stokes KB. (1988) Polyether polyurethanes: Biostable or not? J Biomater Appl 3(2):228–260.CrossRefGoogle Scholar
  5. 5.
    Stokes KB (1997) Polyurethane pacemaker leads: The contribution of clinical experience to the elucidation of failure modes and biodegradation mechanisms. In KB Witkin (Ed) Clinical studies of medical devices and diagnostics: Principles and approaches. Humana Press, Totowa NJ.Google Scholar
  6. 6.
    Stokes KB and Cobian K (1982) Polyether polyurethanes for implantable pacemaker leads. Biomaterials 3:225–231.CrossRefGoogle Scholar
  7. 7.
    Stephenson NL. (1980) Synopsis of clinical report on the Spectraflex models 6971/72 transvenous leads. Medtronic News. X(3):16.MathSciNetGoogle Scholar
  8. 8.
    Stephenson NL. (1980) Synopsis of clinical report on the Models 6990U/91U atrial J leads transvenous leads. Medtronic News X(2):16.Google Scholar
  9. 9.
    Hawkins WI. (1972) Polymer stabilization. Wiley InterScience, New York.Google Scholar
  10. 10.
    Schnabel W. (1981) Polymer Degradation. Hanser, Vienna, (Distributed in the US by Macmillan Publishing Co, New York, NY).Google Scholar
  11. 11.
    Anderson JM. (1996) Host reactions to biomaterials and their evaluation. In Ratner BD, Hoffman AS, Schoen FJ and Lemons JE (Eds) Biomaterials Science. Academic Press, San Diego, Chapter 3, pp. 165–173.Google Scholar
  12. 12.
    Parsonnet V, Zucker IR, Kannerstein ML, et al. (Jul 1966) The fate of permanent intracardiac electrodes. J Surg Res – Clin Lab Invest 6(7):285–292.Google Scholar
  13. 13.
    Zhao QH, McNally AK, Rubin KR, et al. (1993) Human plasma α2-macroglobulin promotes in vitro oxidative stress cracking of Pellethane 2363–80A: In vivo and in vitro correlations. J Biomed Mater Res 27:379–389.CrossRefGoogle Scholar
  14. 14.
    Stokes K, Urbanski P and Upton J. (1990) The in vivo auto-oxidation of polyether polyurethanes by metal ions. J Biomater Sci, Poly Ed 1(3):207–230.CrossRefGoogle Scholar
  15. 15.
    Ward R, Anderson J, McVenes R, et al. (2007) In vivo biostability of polyether polyurethanes with fluoropolymer and polyethylene oxide surface modifying endgroups; resistance to metal ion oxidation. J Biomed Mater Res 80 (1):34–44.CrossRefGoogle Scholar
  16. 16.
    Zhao Q, Casas-Bejar J, Urbanski P, et al. (1995) The glass wool H2O2/CoCl2 test system for in vitro evaluation of biodegradative stress cracking in polyurethane elastomers. J Biomed Mater Res 29:467–475.CrossRefGoogle Scholar
  17. 17.
    Stokes K, Staffanson D, Lessar J, et al. (1987) A possible new complication of subclavian stick: Conductor fracture. VIII World Symposium on Cardiac Pacing and Electrophysiology. Jerusalem, and PACE 10(3), Pt. II: 748 (Abst. 476).Google Scholar
  18. 18.
    Belott P and Reynolds DW (1995) Permanent pacemaker implantation. In Ellenbogen KA, Kay GN, and Wilkoff BL. (Eds) Clinical cardiac pacing. WB Saunders, Philadelphia, Chapter 27, pp. 447–490.Google Scholar
  19. 19.
    Jacobs DM, Fink AS, Miller RP, et al. (1993) Anatomical and morphological evaluation of pacemaker lead compression. PACE. 16:434–443.Google Scholar
  20. 20.
    Magney JE, Flynn DM, Parsons JA, et al. (March 1993) Anatomical mechanisms explaining damage to pacemaker leads, defibrillator leads, and failure of central venous catheters adjacent to the sternoclavicular joint. PACE 16(Pt. I):445–457.Google Scholar
  21. 21.
    Byrd CL. (1992) Safe introducer technique for pacemaker lead implantation. PACE 15:262.Google Scholar
  22. 22.
    Medtronic, Inc. (2007) Cardiac rhythm disease management, product performance report, second edition, issue No. 57.
  23. 23.
    Stokes K, Anderson J, McVenes R, et al. (1995) The encapsulation of transvenous polyurethane insulated cardiac pacemaker leads. Cardiovasc Path 4(3):163–172.CrossRefGoogle Scholar
  24. 24.
    Byrd CL. (2000) Management of implant complications. In Ellenbogen KA, Kay GN and Wilkoff BL (Eds) Clinical Cardiac Pacing and Defibrillation. 2nd Edition. WB Saunders, Philadelphia, pp. 669–694.Google Scholar
  25. 25.
    ISO/DIS 14971Google Scholar
  26. 26.
    ISO/DIS 14971, Annex C, pp. 24–29Google Scholar
  27. 27.
    ISO/DIS 14971, Annex I, pp. 72–73Google Scholar
  28. 28.
    ISO/DIS 14971, Annex E, pp. 45–49Google Scholar
  29. 29.
    (November 1, 2000). Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions. US Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health and Interventional Cardiology Devices Branch, Division of Cardiovascular and Respiratory Devices, Office of Device Evaluation.Google Scholar
  30. 30.
    AAMI/ISO 10993-1: 1997, Biologic evaluation of medical devices-Part 1: Evaluation and testing.Google Scholar
  31. 31.
    Stokes K and Stephenson NL (1982) The implantable cardiac pacing lead – just a simple wire? In Barold SS and Mugica J (Eds) The third decade of cardiac pacing. Futura, Mount Kisko NY, pp. 365–416.Google Scholar
  32. 32.
    Coury A, Hobot C, Cahalan P, et al. (May 15, 1990) In vitro chemical stability of implanted polyurethanes. Fourth University of Minnesota Research Poster Session, Basic and Applied Research in Academia and Industry. Minneapolis, Minnesota.Google Scholar
  33. 33.
    Stokes K. (July–September, 1993). Biodegradation. Cardiovasc Path 2(3 Suppl):111S–119S.CrossRefGoogle Scholar
  34. 34.
    Ratner BD, Gladhill KW, and Horbett TA. (1988) Analysis of in vitro enzymatic and oxidative degradation of polyurethanes. J Biomed Mater Res 22:509–527.CrossRefGoogle Scholar
  35. 35.
    Santeere JP, Labow RS, Duguay DG, et al. (1994) Biodegradation evaluation of polyether and polyester urethanes with oxidative and hydrolytic enzymes. J Biomed Mater Res 28:1187–1199.CrossRefGoogle Scholar
  36. 36.
    Cobian KE, Miller J, and Ebert M (1998) New improved silicone rubber for lead insulation. Medtronic technical concept paper number UC9704728IE.Google Scholar
  37. 37.
    Bonart R. (1968) X ray investigations concerning the physical structure of crosslinking in segmented elastomers. J Macromol Sci Phys B2:115.Google Scholar
  38. 38.
    Bonart R, Morbitzer L, and Hentz G. (1969) X ray investigations concerning the physical structure of crosslinking in segmented elastomers. II. Butanediol as chain extender. J Macromol Sci Phys 3:337.CrossRefGoogle Scholar
  39. 39.
    Ward R, Anderson J, Ebert M, et al. (2006) In vivo biostability of polysiloxane polyether polyurethanes; Resistance to metal ion oxidation. J Biomed Mater Res 77(2):380–389.CrossRefGoogle Scholar
  40. 40.
    Ward R, Anderson J, McVenes R, et al. (2006) In vivo biostability of polysiloxane polyether polyurethanes; resistance to biologic oxidation and stress cracking. J Biomed Mater Res 77(3):580–589.CrossRefGoogle Scholar
  41. 41.
    Ward R, Anderson J, McVenes R, et al. (2006) In vivo biostability of polyether polyurethanes with fluoropolymer surface modifying endgroups; Resistance to biologic oxidation and stress cracking. J Biomed Mater Res 79(4):827–835.CrossRefGoogle Scholar
  42. 42.
    Ward R, Anderson J, McVenes R, et al. (2006) In vivo biostability of Shore 55D polyether polyurethanes with and without fluoropolymer surface modifying endgroups. J Biomed Mater Res 79(4):837–845.Google Scholar

Copyright information

© Springer Science+Business Media, LLC 2009

Authors and Affiliations

  1. 1.Brady Leads Research, Cardiac Rhythm Disease Management DivisionMedtronic, Inc.BrainerdUSA

Personalised recommendations