Covidien, a company that supplies a class of products used in echocardiography, has released new information on its use of drugs in the medical history of 1,210 patients exposed to ultrasonic defibrillation (C-19). Of these patients, 126 died. Patients in this group would be roughly 34 percent more likely to have died after undergoing C-19 therapy than those in the control group.
The Covidien study was the first of three trials that funded by the FDA. The Covidien trial was considered small and therefore small comparisons were made between the groups. In this trial, the participants were 116 patients aged 17 years or older who had undergone transcatheter mitral valve replacement surgery (TMMR) or within the first week after the surgery.
In April 2010, after the lead author of the study, Elizabeth Kauffman, met with FDA officials, it became evident that the FDA would request additional information, such as data on previous cycles of C-19 therapy and on side effects related to C-19. In the review, FDA officials also found that the study’s principal investigators may have committed misleading statements to treat the study as a small-risk study.
While the FDA initially recommended that Covidien return to the study for a follow-up, FDA staff encouraged the company to move forward with a consultation with a specialty cardiac device registrar about whether they would need to re-do the study.
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