Advanced search
Publication Cover
Expert Review of Medical Devices Volume 3, 2006 - Issue 6
Submit an article Journal homepage
46
Views
5
CrossRef citations to date
0
Altmetric
Perspective

US FDA perspective on regulatory issues affecting circulatory assist devices

Wolf Sapirstein Division of Cardiovascular Devices, Office of Device Evaluation, Center for Devices and Radiological Health, US FDA, 9200 Corporate Boulevard, Rockville, MD 20850, USA. [email protected]
,
Eric Chen Division of Cardiovascular Devices, Office of Device Evaluation, Center for Devices and Radiological Health, US FDA, 9200 Corporate Boulevard, Rockville, MD 20850, USA.
,
Julie Swain Division of Cardiovascular Devices, Office of Device Evaluation, Center for Devices and Radiological Health, US FDA, 9200 Corporate Boulevard, Rockville, MD 20850, USA.
&
Bram Zuckerman Division of Cardiovascular Devices, Office of Device Evaluation, Center for Devices and Radiological Health, US FDA, 9200 Corporate Boulevard, Rockville, MD 20850, USA.
Pages 749-753 | Published online: 09 Jan 2014

References

  • Hogness JR, Van Antwerp M. The Artificial Heart. Institute of Medicine National Academy Press, Washington DC, USA (1991).
  • Guyton RA, Schonberger JP, Everts PA et al. Postcardiotomy shock: clinical evaluation of the BVS 5000 Biventricular Support System. Ann. Thorac. Surg.56(2), 346–356 (1993).
  • Pennington DG, Swartz MT, Lohmann DP, McBride LR. Cardiac assist devices. Surg. Clin. N. Am.78(5), 691–704 (1998).
  • Frazier OH, Rose EA, Oz MC et al. Improved mortality and rehabilitation of transplant candidates treated with long-term implantable left ventricular assist system. Ann. Surg.222(3), 327–336; discussion 336–338 (1995).
  • Catanese KA, Goldstein DI, Williams DL et al. Outpatient left ventricular assist device support. Ann. Thorac. Surg.62(3), 646–652; discussion 653 (1996).
  • Rose EA, Gellins AC, Moskowitz AJ et al. Long-term use of a left ventricular assist device for end-stage heart failure. N. Engl. J. Med.345, 1435 (2001).
  • Copeland JG, Smith RG, Arabia FA et al. Cardiac replacement with a total artificial heart as a bridge to transplantation. N. Engl. J. Med.351(9), 859–867 (2004).
  • Abiomed BVS Worldwide Registry. Abiomed Cardiovascular Inc., MA, USA (2000).
  • Stevenson LW, Kormos RL. Mechanical Cardiac Support 2000. JACC37, 340–370 (2001).
  • Baldwin JT, Borovetz HS, Duncan BW et al. The National Heart, Lung and Blood Institute Pediatric Ciculatory Support program. Circulation113, 147 (2006).
  • Freedman B. Equipoise and the ethics of clinical research. N. Engl. J. Med.317(3), 141–145(1987).

Patent

  • Federal Register. 43 FR 32988. Washington DC. Govt Printing Office, USA.

Websites

  • Willman VL. Expert panel review of the NHLBI total artificial heart program www.nhlbi.nih.gov/resources/docs/ tah-rpt.htm.1999
  • FDA advisory panel for Abiocor Implantable Replacement Heart www.fda.gov/cdrh/pma/pma2005
  • Least burdensome provisions of the FDA Modenization Act of1997 www.fda.gov/cdrh/ode/guidance/1332.pdf
  • Interagency Registry for Mechanically Assisted Circulatory Support www.intermacs.org

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Order Reprints Request Corporate Permissions

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

Request Academic Permissions

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.