FDA Grants Marketing of New Device for Continuous Dialysis T
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US FDA granted marketing authorization for CARPEDIEM System, indicated to provide continuous hemodialysis or hemofiltration therapy.

~ to critically ill pediatric patients weighing between 2.5 and 10 kilograms (or 5.5 to 22 pounds),
~ having sudden or temporary loss of kidney function (acute kidney injury) or fluid overload.

Continuous hemodialysis or hemofiltration therapy – known as continuous renal replacement therapy (CRRT) – involves using a dialysis machine and dialyzer, to continuously clean the patient’s blood for an extended period of time, without stopping, instead of the more traditional three times a week therapy session.

The FDA evaluated data showed a 97% survival rate to discontinuation of CRRT in patients weighing less than 10 kilograms (or 22 pounds) treated with the CARPEDIEM System

The survival rate at discharge from the ICU was 55% in patients treated with the CARPEDIEM System compared to 43% in patients treated with other CRRT devices.

The FDA granted marketing authorization of the CARPEDIEM System to Medtronic Inc.

Source: https://www.fda.gov/news-events/press-announcements/fda-grants-marketing-new-device-continuous-dialysis-therapy-use-pediatric-patients-certain-kidney
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