Developments in metallic biodegradable stents

Acta Biomaterialia

Volumn 6, Issue 5, 2010, Pages 1693-1697

  Hermawan, H ^a   Dube D ^a   Mantovani, D ^a  

^a UNIVERSITÉ LAVAL   (Canada)

Author keywords

Biodegradable stent; Degradable biomaterials; Iron; Magnesium; Metal

Indexed keywords

MAGNESIUM; PATENTS AND INVENTIONS; STENTS;

ARTERIAL VESSELS; BIODEGRADABLE STENTS; BIOMATERIAL RESEARCH; BIOMEDICAL IMPLANTS; CORONARY STENTS; DATABASE RECORDS; DEGRADABLE BIOMATERIALS; METALLICS; PATENT DATABASE; SCIENTIFIC JOURNALS;

IRON;

ALLOY; ANTITHROMBOCYTIC AGENT; BIOMATERIAL; FERROMAGNETIC MATERIAL; IRON; MAGNESIUM; MAGNESIUM ALLOY; MAGNESIUM DERIVATIVE; METAL; POLYCAPROLACTONE; POLYGLYCOLIC ACID; POLYLACTIC ACID; POLYMER; SS316L; UNCLASSIFIED DRUG;

AORTA COARCTATION; BARE METAL STENT; BIOCOMPATIBILITY; BIODEGRADABLE IMPLANT; CLINICAL TRIAL; CRITICAL LIMB ISCHEMIA; DRUG COATING; DRUG ELUTING STENT; HUMAN; IN VITRO STUDY; IN-STENT RESTENOSIS; LIMB ISCHEMIA; METAL IMPLANTATION; METALLIC BIODEGRADABLE STENT; NANOFABRICATION; NONHUMAN; PATENT; PRIORITY JOURNAL; PROSPECTIVE STUDY; PUBLICATION; RABBIT; REVIEW; STENT THROMBOSIS; VALIDATION PROCESS; ANIMAL; CHEMISTRY; REPRODUCIBILITY; STENT;

ABSORBABLE IMPLANTS; ALLOYS; ANIMALS; CLINICAL TRIALS AS TOPIC; HUMANS; METALS; REPRODUCIBILITY OF RESULTS; STENTS;

EID: 77954673809     PISSN: 17427061     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.actbio.2009.10.006     Document Type: Review

References (62)

1. M. Peuster, P. Wohlsein, M. Brugmann, M. Ehlerding, K. Seidler, and C. Fink A novel approach to temporary stenting: degradable cardiovascular stents produced from corrodible metal-results 6-18 months after implantation into New Zealand white rabbits Heart 86 2001 563 569
2. B. Heublein, R. Rohde, V. Kaese, M. Niemeyer, W. Hartung, and A. Haverich Biocorrosion of magnesium alloys: a new principle in cardiovascular implant technology? Heart 89 2003 651 656
3. P. Zartner, R. Cesnjevar, H. Singer, and M. Weyand First successful implantation of a biodegradable metal stent into the left pulmonary artery of a preterm baby Catheter Cardiovasc Interv 66 2005 590 594
4. D. Schranz, P. Zartner, I. Michel-Behnke, and H. Akinturk Bioabsorbable metal stents for percutaneous treatment of critical recoarctation of the aorta in a newborn Catheter Cardiovasc Interv 67 2006 671 673
5. P. Peeters, M. Bosiers, J. Verbist, K. Deloose, and B. Heublein Preliminary results after application of absorbable metal stents in patients with critical limb ischemia J Endovasc Ther 12 2005 1 5
6. M. Bosiers, P. Peeters, O. D'Archambeau, J. Hendriks, E. Pilger, and C. Duber AMS INSIGHT-absorbable metal stent implantation for treatment of below-the-knee critical limb ischemia: 6-month analysis Cardiovasc Intervent Radiol 2009 10.1007/s00270-00008-09472-0027
7. R. Erbel, C. Di Mario, J. Bartunek, J. Bonnier, B. de Bruyne, and F.R. Eberli Temporary scaffolding of coronary arteries with bioabsorbable magnesium stents: a prospective, non-randomised multicentre trial Lancet 369 2007 1869 1875
8. P.W. Serruys, P. de Jaegere, F. Kiemeneij, C. Macaya, W. Rutsch, G. Heyndrickx, H. Emanuelsson, J. Marco, V. Legrand, and P. Materne A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group N Engl J Med 331 1994 489 495
9. D.L. Fischman, M.B. Leon, D.S. Baim, R.A. Schatz, M.P. Savage, I. Penn, K. Detre, L. Veltri, D. Ricci, and M. Nobuyoshi A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators N Engl J Med 331 1994 496 501
10. P.H. Grewe, D. Thomas, A. Machraoui, J. Barmeyer, and K.M. Muller Coronary morphologic findings after stent implantation Am J Cardiol 85 2000 554 558
11. R. Virmani, A. Farb, G. Guagliumi, and F.D. Kolodgie Drug-eluting stents: caution and concerns for long-term outcome Coron Artery Dis 15 2004 313 318
12. A.K. Mitra, and D.K. Agrawal In stent restenosis: bane of the stent era J Clin Pathol 59 2006 232 239
13. R. Hoffmann, G.S. Mintz, G.R. Dussaillant, J.J. Popma, A.D. Pichard, and L.F. Satler Patterns and mechanisms of in-stent restenosis. A serial intravascular ultrasound study Circulation 94 1996 1247 1254
14. A.T. Ong, E.P. McFadden, E. Regar, P.P. de Jaegere, R.T. van Domburg, and P.W. Serruys Late angiographic stent thrombosis (LAST) events with drug-eluting stents J Am Coll Cardiol 45 2005 2088 2092
15. R. Waksman Update on bioabsorbable stents: from bench to clinical J Interv Cardiol 19 2006 414 421
16. M.M. El-Omar, G. Dangas, I. Iakovou, and R. Mehran Update on in-stent restenosis Curr Interv Cardiol Rep 3 2001 296 305
17. A. Schomig, A. Kastrati, H. Mudra, R. Blasini, H. Schuhlen, and V. Klauss Four-year experience with Palmaz-Schatz stenting in coronary angioplasty complicated by dissection with threatened or present vessel closure Circulation 90 1994 2716 2724
18. P.W. Serruys, M.J. Kutryk, and A.T. Ong Coronary-artery stents N Engl J Med 354 2006 483 495
19. C. Di Mario, and G. Ferrante Biodegradable drug-eluting stents: promises and pitfalls Lancet 371 2008 873 874
20. Klocke B, Diener T, Fringes M, Harder C. Degradable metal stent having agent-containing coating. USPTO 2009: US20090030507.
21. Orlowski M, Rubben A. Bioresorbable metal stent with controlled resorption. WIPO 2008: WO2008092436.
22. Asgari S. Biodegradable porous stent. WIPO 2008: WO2008098922.
23. Tessier JM, Brown WG. Method and apparatus for laser cutting a hollow metal workpiece. USPTO 1991: US5073694.
24. Muller F. Method of cutting an aperture in a device by means of a laser beam. USPTO 1994: US5345057.
25. Saunders RJ. Method and apparatus for direct laser cutting of metal stents. USPTO 2002: US20026369355.
26. Globerman O. Medical stents, apparatus and method for making same. USPTO 2002: US20026428570.
27. Acciai MA, Hall RR, Legg JT. Tooling for forming a stent USPTO 2003: US20036514063.
28. R.S. Stack, R.M. Califf, H.R. Phillips, D.B. Pryor, P.J. Quigley, and R.P. Bauman Interventional cardiac catheterization at Duke Medical Center Am J Cardiol 62 1988 3F 24F
29. W.J. van der Giessen, A.M. Lincoff, R.S. Schwartz, H.M. van Beusekom, P.W. Serruys, and D.R. Holmes Jr. Marked inflammatory sequelae to implantation of biodegradable and nonbiodegradable polymers in porcine coronary arteries Circulation 94 1996 1690 1697
30. H. Tamai, K. Igaki, E. Kyo, K. Kosuga, A. Kawashima, and S. Matsui Initial and 6-month results of biodegradable poly-l-lactic acid coronary stents in humans Circulation 102 2000 399 404
31. T. Tsuji, H. Tamai, K. Igaki, E. Kyo, K. Kosuga, and T. Hata Biodegradable polymeric stents Curr Interv Cardiol Rep 3 2001 10 17
32. R. Waksman, R. Pakala, P.K. Kuchulakanti, R. Baffour, D. Hellinga, and R. Seabron Safety and efficacy of bioabsorbable magnesium alloy stents in porcine coronary arteries Catheter Cardiovasc Interv 68 2006 606 617
33. J. Levesque, H. Hermawan, D. Dube, and D. Mantovani Design of a pseudo-physiological test bench specific to the development of biodegradable metallic biomaterials Acta Biomater 4 2008 284 295
34. R. Waksman, R. Pakala, R. Baffour, R. Seabron, D. Hellinga, and F.O. Tio Short-term effects of biocorrodible iron stents in porcine coronary arteries J Interv Cardiol 21 2008 15 20
35. H. Hermawan, H. Alamdari, D. Mantovani, and D. Dubé Iron-manganese: new class of degradable metallic biomaterials prepared by powder metallurgy Powder Metall 51 2008 38 45
36. R. Balcon, R. Beyar, S. Chierchia, I. De Scheerder, P.G. Hugenholtz, and F. Kiemeneij Recommendations on stent manufacture, implantation and utilization Eur Heart J 18 1997 1536 1547
37. Heublein B, Hausdorf G. Metallic stent which is degradable in vivo. EPO 2002: EP1270023.
38. J. Levesque, D. Dube, M. Fiset, and D. Mantovani Investigation of corrosion behaviour of magnesium alloy AM60B-F under pseudo-physiological conditions Mater Sci Forum 426-432 2003 521 526
39. Bolz A, Popp T. Implantable, bioresorbable vessel wall support, in particular coronary stent. USPTO 2001: US20016287332.
40. M. Peuster, C. Hesse, T. Schloo, C. Fink, P. Beerbaum, and C. von Schnakenburg Long-term biocompatibility of a corrodible peripheral iron stent in the porcine descending aorta Biomaterials 27 2006 4955 4962
41. Mueller H. Stent having a base body of a biocorrodable alloy. USPTO 2009: US20090069884.
42. N.C. Andrews Disorders of iron metabolism N Engl J Med 341 1999 1986 1995
43. J. Emsley The elements 1998 Clarendon Press Oxford
44. P.P. Mueller, T. May, A. Perz, H. Hauser, and M. Peuster Control of smooth muscle cell proliferation by ferrous iron Biomaterials 27 2006 2193 2200
45. N.E. Saris, E. Mervaala, H. Karppanen, J.A. Khawaja, and A. Lewenstam Magnesium. An update on physiological, clinical and analytical aspects Clin Chim Acta 294 2000 1 26
46. J. Vormann Magnesium: nutrition and metabolism Mol Aspects Med 24 2003 27 37
47. G. Song Control of biodegradation of biocompatible magnesium alloys Corros Sci 49 2007 1696 1701
48. ASTM F 138: Standard specification for wrought 18chromium-14nickel-2. 5molybdenum stainless steel bar and wire for surgical implants (UNS S31673). West Conshohocken: ASTM International; 2003.
49. Goodfellow Corporation. Iron (Fe)-material information. http://www.goodfellow.com/csp/active/STATIC/A/Iron.HTML (accessed 2009.05.05).
50. ASTM. ASTM B 80: Standard specification for magnesium-alloy sand castings. West Conshohocken: ASTM International; 2001.
51. Z. Li, X. Gu, S. Lou, and Y. Zheng The development of binary Mg-Ca alloys for use as biodegradable materials within bone Biomaterials 29 2008 1329 1344
52. J. Currey Cortical bone J. Black, G. Hastings, Handbook of biomaterial properties 1998 Chapman & Hall London 3 14
53. M.P. Staiger, A.M. Pietak, J. Huadmai, and G. Dias Magnesium and its alloys as orthopedic biomaterials: a review Biomaterials 27 2006 1728 1734
54. ASTM G 31: Standard practice for laboratory immersion corrosion testing of metals. West Conshohocken, PA: ASTM International; 2001.
55. ASTM G 59: Standard test method for conducting potentiodynamic polarization resistance measurements. West Conshohocken, PA: ASTM International; 2001.
56. ASTM F 2129: Standard test method for conducting potentiodynamic measurement to determine the corrosion susceptibility of small implant devices. West Conshohocken, PA: ASTM International; 2004.
57. ISO 10993-5: Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity. Arlington, VA: ANSI/AAMI; 1999.
58. R. Waksman, R. Pakala, T. Okabe, D. Hellinga, R. Chan, and M.O. Tio Efficacy and safety of absorbable metallic stents with adjunct intracoronary beta radiation in porcine coronary arteries J Interv Cardiol 20 2007 367 372
59. M. Peuster, P. Beerbaum, F.W. Bach, and H. Hauser Are resorbable implants about to become a reality? Cardiol Young 16 2006 107 116
60. P. Zartner, M. Buettner, H. Singer, and M. Sigler First biodegradable metal stent in a child with congenital heart disease: evaluation of macro and histopathology Catheter Cardiovasc Interv 69 2007 443 446
61. C.J. McMahon, P. Oslizlok, and K.P. Walsh Early restenosis following biodegradable stent implantation in an aortopulmonary collateral of a patient with pulmonary atresia and hypoplastic pulmonary arteries Catheter Cardiovasc Interv 69 2007 735 738
62. M.C. Morice, P.W. Serruys, J.E. Sousa, J. Fajadet, E. Ban Hayashi, and M. Perin A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization N Engl J Med 346 2002 1773 1780