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SeaStar’s Device Receives Humanitarian Device Exemption Status to Aid Children with AKI

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In the wake of encouraging clinical results, SeaStar Medical, a pioneering entity in the medical device industry, has garnered approval from the prestigious US Food and Drug Administration (FDA) for a humanitarian device exemption (HDE) status for its groundbreaking Quelimmune selective cytopheretic device (SCD). This innovative device is specifically tailored for pediatric patients grappling with the challenges of acute kidney injury (AKI), marking a significant milestone in pediatric healthcare.

Acute kidney injury, characterized by a sudden loss of normal kidney function, poses serious health risks, particularly in pediatric populations. Recognizing the pressing need for effective interventions in this domain, SeaStar Medical embarked on a journey to develop a solution that could potentially revolutionize the management of AKI in children.

The Quelimmune SCD, which previously garnered FDA breakthrough device designation in October 2023, represents the culmination of extensive research, development, and clinical validation efforts aimed at addressing the unmet needs of pediatric patients suffering from AKI. The FDA’s granting of an humanitarian device exemption for this innovative device underscores its potential to significantly enhance the standard of care for pediatric AKI management.

An humanitarian device exemption, a specialized regulatory pathway established by the FDA, is reserved for medical devices intended to address conditions affecting small patient populations. This designation reflects the FDA’s recognition of the unique challenges associated with pediatric AKI and the urgent need for innovative solutions to improve patient outcomes in this vulnerable population.

Transforming Pediatric Nephrology with SeaStar Medical’s Innovative AKI Solution

SeaStar’s Quelimmune SCD stands out as a beacon of hope for pediatric patients and their families, offering a ray of optimism amidst the challenges posed by AKI. By securing humanitarian device exemption approval, SeaStar Medical has cleared a crucial regulatory hurdle, paving the way for the device’s availability to healthcare providers and patients in need.

Moving forward, SeaStar Medical remains committed to advancing the field of pediatric nephrology through ongoing research, clinical trials, and collaborative partnerships with healthcare professionals and regulatory authorities. The company’s unwavering dedication to scientific excellence and patient-centric innovation underscores its vision of transforming pediatric healthcare and improving the quality of life for children worldwide.

With the Quelimmune SCD poised to make a tangible impact in the realm of pediatric AKI management, SeaStar Medical is poised to redefine the standards of care and set new benchmarks for excellence in pediatric nephrology. As the device prepares for market launch, anticipation mounts within the medical community, signaling a new era of hope and progress in the fight against pediatric AKI.

The Quelimmune SCD, which earned FDA breakthrough device designation in October 2023, is tailored for pediatric patients weighing at least 10kg who are experiencing AKI due to sepsis or a septic condition necessitating kidney replacement therapy (KRT).

An humanitarian device exemption is a regulatory pathway reserved for medical devices designed to address conditions affecting small patient populations. Although humanitarian device exemptions are exempt from certain efficacy requirements compared to other regulatory pathways, they are subject to profit caps and specific usage restrictions as mandated by FDA regulations.

SeaStar’s SCD-PED device, formulated for pediatric use, has now been authorized for marketing as a humanitarian use device (HUD), marking the inaugural product in the Quelimmune product line, as stated in a press release issued by the company on February 21.

Humanitarian Device Exemption

Quelimmune Achieves Significant Milestones with Humanitarian Device Exemption Status and Promising Clinical Outcomes

Expressing optimism about the approval, SeaStar’s CEO, Eric Schlorff, emphasized that this development offers critically ill children suffering from AKI access to much-needed innovative therapy.

Despite the humanitarian device exemption designation, manufacturers are still obligated to demonstrate that the benefits of the device outweigh its potential risks. SeaStar presented data from the FDA-funded Phase II studies, SCD-PED-01 (NCT02820350) and SCD-PED-02 (NCT04869787), revealing a remarkable 77% reduction in mortality rates among the target population. Notably, participants achieved independence from dialysis by day 60 and reported no serious adverse events or device-related infections. Currently, SeaStar is conducting its pivotal NEUTRALIZE-AKI clinical trial, targeting a broader adult AKI population, with an estimated enrollment of up to 200 patients (NCT05758077).

SeaStar anticipates the device’s rollout shortly and has entered into a licensing and distribution partnership with Nuwellis for the US market. The SCD employs cell-directed extracorporeal therapy via continuous kidney replacement therapy, selectively targeting and neutralizing neutrophils and monocytes, pivotal effector cells involved in hyperinflammation. Following neutralization, these cells are reintroduced into the bloodstream. Typically, immune system overactivity can lead to organ damage and even multi-organ failure.

AKI manifests as an abrupt cessation of normal kidney function, and currently, there are no FDA-approved pharmacological interventions for the condition. However, ongoing clinical trials, such as CalciMedica’s Auxora for AKI associated with acute hypoxemic respiratory failure (AHRF), are exploring potential treatment options.


Resource: Medical Device Network, February 23, 2024

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