Zobrazeno 1 - 10 of 11 pro vyhledávání: '"Wolf Sapirstein"'
2
FDA Approval of Coronary-Artery Brachytherapy
Autor: Wolf Sapirstein, James Dillard, Bram Zuckerman
Publikováno v: New England Journal of Medicine. 344:297-299
Recurrent coronary stenosis occurs in 20 to 30 percent of patients in whom stents have been implanted for the treatment of obstructive lesions; when it occurs within the stent, it is referred to as in-stent restenosis. Not only is such stenosis a cha
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::dabdfdb9b421baa2ab2efe9644162b91
https://doi.org/10.1056/nejm200101253440410
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3
US FDA perspective on regulatory issues affecting circulatory assist devices
Autor: Wolf Sapirstein, Bram Zuckerman, Julie A. Swain, Eric A. Chen
Publikováno v: Expert review of medical devices. 3(6)
There has been a rapid development in mechanical circulatory support systems in the decade since the US FDA first approved a mechanical device to provide the circulatory support lacking from a failing heart. Devices are presently approved for marketi
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d9dedc2166277fa43d5f765d27c08de3
https://pubmed.ncbi.nlm.nih.gov/17280539
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6
Database: relevant or not
Autor: Walter E. Pae, Robert L. Kormos, Wolf Sapirstein, Peter S. Greene
Publikováno v: The Annals of thoracic surgery. 71
Progress in the field of ventricular assist devices requires a more rigorous and systematic method of collecting outcomes data. A worldwide registry of device implants and results is proposed. With widespread participation, data from this registry wo
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9dc4656f1741a0aeac9ecaf4fca82f91
https://pubmed.ncbi.nlm.nih.gov/11265864
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7
The conduct of clinical trials: a Food and Drug Agency perspective
Autor: Wolf Sapirstein
Publikováno v: ASAIO journal (American Society for Artificial Internal Organs : 1992). 46(1)
The conduct of a clinical trial required by FDA regulations should be executed in conformity with a protocol developed as a cooperative endeavor involving the Agency, the sponsor requiring device approval for marketing, and the investigators. This is
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::493215276e7149720801840f9c4ef3cf
https://pubmed.ncbi.nlm.nih.gov/10667711
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8
FDA perspective on clinical trial design for femoropopliteal stent correction of peripheral vascular insufficiency cardiovascular devices
Autor: Bram Zuckerman, Jennifer L. Goode, Wolf Sapirstein
Publikováno v: Catheterization and Cardiovascular Interventions. 69:920-921
The article by Rocha-Singh et al. [1]. on behalf of the VIVA Physicians Incorporate (VPI) in this issue of the Catheterization and Cardiac Interventions addresses the challenge to designing clinical trials for devices intended to correct femoropoplit
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::d4b6adbe372732df17acc9a3d06e42b2
https://doi.org/10.1002/ccd.21209
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