Published in Medical Letter on the CDC and FDA, June 26th, 2005
"The CarboMedics bileaflet prosthetic heart valve was first implanted as part of a prospective clinical study at the authors' institution in November 1987. The patient cohort included was part of a multicenter trial set up by the manufacturer for an FDA application. The present report details findings over a 15-year period, with a continuous follow up on this patient cohort. Between November 1987 and August 1990, 132 patients (68 males, 64 females; median age 56 years; range: 12-74 years) received a CarboMedics heart valve prosthesis. All patients were included in the study,...
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