PRISMAFLEX HF20 Set Resources

The PRISMAFLEX HF20 Set has been Authorized by the FDA to provide continuous renal replacement therapy (CRRT) to treat low weight (8-20 kg) and low blood volume patients or patients who have acute renal failure, fluid overload, or both, and who cannot tolerate a larger extracorporeal circuit volume in an acute care environment during the Coronavirus Disease 2019 (COVID-19) pandemic. The PRISMAFLEX HF20 Set has neither been cleared or approved to provide CRRT in an acute care environment. The PRISMAFLEX HF20 Set has been authorized by FDA under EUA201769. The PRISMAFLEX HF20 Set is Authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the PRISMAFLEX HF20 Set under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
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“We use the filter to support low weight patients who are particularly vulnerable during COVID-19. The device helps us manage the need these patients have for albumin/blood prime (which are in short supply) with non-peds tubing to support hemodynamic instability.”

- Stuart Goldstein, MD, FAAP, FNKF

Director, Center for Acute Care Nephrology, Cincinnati Children’s Hospital Medical Center, and Professor of Pediatrics, University of Cincinnati College of Medicine, Division of Nephrology and Hypertension, Cincinnati, OH

STUDY RESULTS

A suitable alternative to larger filter sets for use in patients weighing less than 20 kg1

A recent multicenter, open-label single group study determined the PRISMAFLEX HF20 filter set, which has a relatively low extracorporeal blood volume of 60 mL, and the corresponding PRISMAFLEX System Software Version 7.10 and 7.20, deliver suitable kidney replacement therapy to treat AKI, fluid overload, or both in patients weighing 8–20 kg.

38% REDUCTION IN BUN WITH HF20 FILTER

Reduced blood urea nitrogen (BUN) by <38% from CRRT initiation to 24 hours.

No blood prime required with HF20

The smaller membrane surface area and filter set volume (60 mL) permitted initiation of CRRT without the requirement for a blood prime, helping to ensure that less than 10% of total blood volume in patients ≥ 8 kg is extracorporeal.

PDF Resources

Fact Sheet for Healthcare Providers

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Fact Sheet for Patients

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PRISMAFLEX HF20 EUA Letter of Authorization

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PRISMAFLEX HF20 Set Specifications

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PRISMAFLEX HF20 Instructions for Use

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Rx Only. For safe and proper use of products mentioned herein refer to the appropriate Instructions for Use or Operator's Manual.