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Even in 2021, therapeutic options for critically ill patients under attack by a cytokine storm are limited. SeaStar Medical’s Selective Cytopheretic Device (SCD) is a patented, next-level immunomodulator that works with any continuous renal replacement therapy (CRRT) system (and regional citrate anticoagulation) to selectively target hyperactive neutrophils and monocytes. SCD technology won’t just stop the storm, but could potentially reverse the damage.
Neutrophils and monocytes are leukocytes that play a key role in life-threatening hyperinflammation.
The novel SCD technology sequesters and neutralizes activated toxic neutrophils, providing a new therapeutic approach to systemic inflammatory response syndrome.1
By restoring reparative physiology, the SCD can help the body heal—potentially eliminating dialysis dependency and getting patients out of the ICU faster so they can return to their loved ones and daily lives.
Currently, drug treatments for a cytokine storm may differ based on the specific disorder associated with it, and these treatments may not deliver the results your patients need.
Because the SCD is an extracorporeal immunomodulator that uses the body’s immune system to heal, you’re in complete control of an effective adjuvant therapy that can be used without the worry of severe contraindications.
SeaStar Medical is committed to introducing only rigorously researched, clinically validated therapeutic products to the market. And the reason is simple: vital organs and precious lives are at stake. Currently an investigational product, the SCD is a prime example of our high standard of performance.
The Food and Drug Administration (FDA) funded an open-label, multicenter, prospective study of SCD in critically ill children with acute kidney injury (AKI) and multiorgan dysfunction (MOD) requiring CRRT. This is a rare condition for children with few available treatment options.1
The results from this study were presented at the American Society of Nephrology Kidney Week 2020 meeting:
Primary endpoint: Safety
Secondary endpoints: Mortality and renal replacement therapy dependency at Day 60
Number of participants: N=16 meeting the FDA’s target enrollment goal
Results:
SeaStar Medical is now conducting the SCD005 study, a multicenter, pilot trial with 30 adult patients who have AKI or ARDS associated with COVID-19. Key objectives of the study are those that matter most to critical-care clinicians:
An earlier study in adults demonstrated that SCD therapy was effective in reducing mortality and dialysis dependency 60 days after treatment in patients with AKI and MOD requiring CRRT.2
There are very few therapeutic options available to treat pediatric AKI…these positive [study] results suggest a favorable benefit to risk ratio in the critically ill pediatric population.
The SCD can be easily added to your extracorporeal therapies, such as dialysis or continuous renal replacement (CRRT), seamlessly fitting into your workflow. It has been used with other treatments, including IL-6 blockers, corticosteroids and other common treatments, with no or few known contraindications.
By giving your critically ill patients the potential to eliminate dialysis dependency, get out of the ICU faster, and restore the lives they were so close to losing, the SCD is positioned to become the new standard of care in the ICU.
Intrigued by the promise of the SCD? Want to know more? We’ll be happy to hear from you.
References: 1. Goldstein SL, Askenazi DJ, Basu RK, et al. Use of the Selective Cytopheretic Device in Critically Ill Children. Kidney International Reports. 2020. https://doi.org/10.1016/j.ekir.2020.12.010. 2. Tumlin JA, Galphin CM, Tolwani AJ, et al. A multi-center, randomized, controlled, pivotal study to assess the safety and efficacy of a selective cytopheretic device in patients with acute kidney injury. PLoS One. 2015;10(8):e0132482. PMID: 26244978.
The SCD is an investigational device and is not currently available for sale. Please check back for further updates on device availability in your region.
SeaStar Medical is a privately held medical device company that has redefined how extracorporeal therapies may reduce the consequences of excessive inflammation on vital organs through novel solutions and services. SeaStar Medical’s focus is on removing pro-inflammatory mediators, known as cytokines, or transforming key immune system messengers from pro-inflammatory to reparative physiology. SeaStar Medical’s next generation technologies rely on science and innovation to build upon existing purification technologies to provide life-saving solutions to critically ill patients.
©SeaStar Medical 2021