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Perspective

Regulatory issues facing the development of drug-eluting stents: a US FDA perspective

Pages 297-300 | Published online: 09 Jan 2014

References

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Websites

  • CYPHER sirolimus-eluting coronary stent on RAPTOR over-the-wire delivery system or RAPTORRAIL rapid exchange delivery system – P020026. FDA, MD, USA, April 24, 2003 www.fda.gov/cdrh/pdf2/p020026.html
  • TAXUS Express 2 paclitaxel-eluting coronary stent system (monorail and over-the-wire) – P030025. FDA, MD, USA, March 4, 2004 www.fda.gov/cdrh/pdf3/p030025.html
  • Krucoff MW. Paclitaxel elution from a bioabsorbable polymer (Conor CoStar). Oral presentation www.tctmd.com/csportal/appmanager/ tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=1278102
  • Morice MC. SYNTAX: insights from the run-in phase. Oral presentation www.tctmd.com/csportal/appmanager/ tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=1256021
  • O’Neill WW. Expanding PCI indications: unprotected left main stenting and distal protection. Oral presentation www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=1354525
  • Leon MB. Thrombogenicity of DES is a growing concern. Cypher – there are no differences in stent thrombosis compared with bare metal stents. Oral presentation www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=1378276
  • Medical Device Reporting www.fda.gov/cdrh/mdr/

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