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INDICATIONS FOR USE

The SCD-PED is intended to treat pediatric patients (weight ≥ 10 kg and age ≤ 22 years) with acute kidney injury (AKI) due to sepsis or a septic condition on antibiotic therapy and requiring renal replacement therapy (RRT).

CONTRAINDICATIONS

Use of the SCD-PED as a standalone unit to provide any renal replacement therapy or fluid and electrolyte management therapy is contraindicated. The SCD-PED cartridge and SCD Blood Tubing Set should not be used on patients who have a known allergy to any of the components in this product.

WARNINGS

Carefully read all warnings, precautions, and instructions before use. Follow all operating, maintenance, and installation procedures as described in this document.
The blood flow path in the SCD-PED is non-sterile.
Operating procedures are to be performed only by trained and qualified clinicians/personnel.
The target post-SCD ionized calcium level during SCD-PED therapy is less than 0.40 mmol/L.
The CKRT device and disposables must be operated by trained personnel according to the instructions for use provided by the manufacturer.
The use of anything other than the SCD Blood Tubing Set provided by SeaStar Medical may result in patient injury.
Do not modify the SCD-PED Cartridge or the SCD Blood Tubing Set in any way.
Carefully inspect barriers of all items prior to use. Do not use item if barrier is damaged.
The SCD-PED Cartridge and SCD Blood Tubing Set are single use sets. Do not sterilize or reuse the SCD-PED Cartridge. Do not re-sterilize or reuse the SCD Blood Tubing Set.
Log or note the lot number of the SCD-PED Cartridge(s) used on a patient in that patient’s Electronic Medical Record (EMR) for tracking purposes.
During the prime and operation procedures, observe closely for blood/fluid leakage at all circuit connections. If tightening the connections does not stop leakage, immediately replace the SCD-PED Cartridge and the SCD Blood Tubing Set. Leakage can cause blood loss or air entry/air embolism.
To prevent contamination, the SCD-PED Cartridge and the SCD Blood Tubing Set must be connected and primed using aseptic technique immediately after opening the packaging and removing caps to make the connections. Use aseptic technique when handling all connections and replacing the SCD-PED Cartridge and the SCD Blood Tubing Set. Universal precautions should be followed to ensure the safety of the patient and clinician.
In the event that a patient decompensates (per the treating physician’s clinical judgment) within 2 hours of a new SCD-PED Cartridge initiation, SCD-PED therapy should be terminated, and a blood sample should be obtained from the patient and cultured for aerobic, anaerobic, and fungal organisms.
Store the SCD-PED Cartridge in a dry place, between 5 °C (41 °F) and 30 °C (86 °F). The upper limit for the SCD Blood Tubing Set is 50 °C (122 °F), with no lower limit specified.

ADVERSE REACTIONS

Five adverse reactions were observed in more than one instance across the two pediatric SCD studies (SCD-PED-01 [16 subjects enrolled] and SCD-PED-02 [6 subjects enrolled]). Those adverse reactions include six instances of hypotension across three subjects, four instances of hypothermia across two subjects, four instances of tachycardia across three subjects, two instances of hyperglycemia across two subjects, and two instances of thrombocytopenia across two subjects.

SCD-PED in the Medical Literature

Poster

The SCD-ADULT is not currently approved by FDA for any purpose.

For information on potential indications or ongoing clinical trials,

please visit the PIPELINE page, or www.clinicaltrials.gov.

These publications are being presented for informative purposes only to healthcare providers and do not constitute an endorsement for any use of the SCD-ADULT, which is an investigational device and has not been approved, cleared, granted marketing authorization, or licensed by FDA, and the safety and effectiveness of this device has not been established. These publications reflect the views and work of the respective authors of each manuscript. Nothing in this material is intended to promote any investigational device nor any unapproved use of an approved device.

SCD-ADULT in the Medical Literature

Poster

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For Healthcare professionals

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SCD-PED in the Medical Literature

2026 AKI-CRRT Poster: SCD Monocyte Phenotype Shifting

2026 AKI-CRRT Poster: SAVE Registry: 18-month Update

SAVE Registry: Early Experience in Pediatric AKI

SCD-PED vs. WE-ROCK Outcomes Analysis

Projected Hospitalization Cost Model of SCD-PED in Pediatric AKI

SCD Mechanism of Action

SCD-PED-01 & PED-02 Pooled Analyses

SCD Safety Summary in AKI

Case Report: SCD Use in Hemolytic Uremic Syndrome (HUS)

SCD-PED-01: SCD Use in Pediatric AKI

The SCD-ADULT is not currently approved by FDA for any purpose.

For information on potential indications or ongoing clinical trials,

please visit the PIPELINE page, or www.clinicaltrials.gov.

SCD-ADULT in the Medical Literature

2026 AKI-CRRT Poster: SCD Monocyte Phenotype Shifting

Impact of SCD on Neutrophil to Lymphocyte Ratio (NLR)

SCD Use in Transplant

Case Report: SCD Use in Toxic Shock Syndrome

Case Report: SCD Use in Hepatorenal Syndrome (HRS)

Editorial: SCD Use in Heart Failure

SCD Safety Summary in AKI

NEUTRALIZE-AKI Study Design

SCD Use in Chronic Heart Failure

SCD-005: SCD Use in COVID-19 Patients

SCD-003: SCD Use in Adult AKI

SCD-002: SCD Use in Adult AKI

SCD Pilot Study

Early SCD Rationale

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