• Class 2a Active Mattress Systems

    Established in 2003, Squirrel Medical® is one of the UK’s only manufacturers exclusively focused on Class IIa active mattress and cushion systems,

    fully certified under UK MDR 2002.

  • Clinical Impact and Patient Outcomes

    As Class IIa medical devices, active mattresses used in higher-risk patient populations are subject to rigorous regulatory oversight under the UK Medical Device Regulations (UK MDR). This includes mandatory conformity assessment by a Notified Body appointed by the Medicines and Healthcare products Regulatory Agency (MHRA). A key requirement of this process is the submission of a comprehensive Clinical Evaluation Report (CER)—a substantial body of evidence combining systematic literature reviews, in-house clinical data, and published peer-reviewed studies. Squirrel Medical has successfully undergone this audit and been awarded a UK MDR Quality Assurance Certificate, confirming compliance with all relevant standards. This certification formally permits the registration and marketing of its system as a Class IIa active medical device in the United Kingdom.

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    University of St Mark & St John

    In a fully independent trial conducted by the University of St Mark & St John (Plymouth), participants slept on the VeSTIMs® mattress for 8 weeks. The results were remarkable.

    • Endothelial Function IMPROVED 197% (p=0.021)
    • Resting Blood Flow IMPROVED 336% (p=0.003)
    • Fat FREE Mass IMPROVED 520 grams (p=0.026)
    • Thermoregulation at Feet IMPROVED 3.5ºC (p<0.001)
    • Blood Pressure IMPROVED 120/77 to 115/75 (p=0.053)
    • Participants reported a reduction in morning stiffness and joint pain.

    Research conducted by University of St Mark and St John, England.

    (1) Baker G, Bloxham S, Laden J, Gush R. Vascular endothelial function is improved after active mattress use. J Wound Care. 2019 Oct 2;28(10):676-682. doi: 10.12968/jowc.2019.28.10.676. PMID: 31600104.

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    EPUAP 2024. A Data-Driven Approach to Pressure Ulcer Management in Long-Term Care: Enhancing Governance and Compliance

    An independently conducted case study by Barchester Healthcare was presented at the European Pressure Ulcer Advisory Panel (EPUAP) Conference 2024, focusing on enhancing patient safety and governance through smart mattress technology. Using the Vestims® Auto 8955a active mattress system, the study demonstrated a 75.9% improvement or stability in pressure ulcer outcomes, with 66% of existing cases showing healing. The study emphasized the system’s value in reducing manual repositioning errors, providing care staff with peace of mind through real-time compliance tracking, and supporting clinical decision-making. With embedded data-logging capabilities, the mattress aligned closely with regulatory frameworks and care quality standards in the UK long-term care sector.

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    Journal of Wound Care

    Published in the Journal of Wound Care, this peer-reviewed study presents the first long-term investigation into the effects of active mattress use on vascular endothelial function. Conducted over 16 weeks, including an 8-week intervention and washout period, the study found significant improvements in resting blood flow (336%), post-occlusive reactive hyperaemia (PORH, 197%), and skin temperature (3.5°C) following active mattress use. These markers collectively indicated enhanced endothelial function in healthy adults. The findings suggest that alternating pressure systems, like the Vestims® mattress, may offer therapeutic benefits far beyond pressure ulcer prevention—potentially influencing vascular health and systemic circulation.

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    Wounds UK 2024.Advancing Pressure Ulcer Prevention with Intelligent Support Surfaces: Resident-Centred Innovation in Complex Care

    Presented at an international healthcare conference in 2024, this study by Barchester Healthcare evaluated a novel fully automatic active dynamic support surface in a complex long-term care setting. Involving eight elderly residents with advanced comorbidities, the study highlighted the system’s ability to automatically adjust to individual patient needs without manual input. Over a four-week period, 75% of residents experienced healing or stability of pressure ulcers, and 66% of those with pre-existing ulcers showed improvement. Residents rated the system highly for comfort, and the automated function minimized caregiver intervention while maintaining safety standards. The findings underscore the potential of advanced air support surfaces to transform pressure ulcer care globally through simplicity, precision, and improved patient experience.

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    PubMed

    This PubMed-indexed study sheds light on an innovative way to promote vascular health—through sleep. Over an 8-week period, healthy adults using a novel active mattress experienced measurable boosts in blood flow and endothelial function, indicators critical for cardiovascular wellness and tissue repair. The mattress mimicked natural repositioning patterns, making it a potentially effective tool for improving circulation without disrupting rest. With implications for aging populations and those at risk for vascular disease, the research suggests a non-invasive, lifestyle-integrated approach to supporting long-term health.

  • Evidence of Regulatory Compliance

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    Medical Device Full Quality Assurance System

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    ISO 13485

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    MHRA Class 2a