Post Market Clinical Follow Up User Survey Report – CELOX Hemostat Device Family

Assessment of real world performance of CELOXTM Hemostat Device Family by trained emergency responders in 2022

CELOXTM Hemostat Devices achieved hemostasis after the first application in 99.3% of cases carried out by respondents including ER physicians, medics, nurses and other emergency personnel.

The study covered 292 cases involving single or multiple wounds ranging from cutting / piercing and blunt trauma to gunshots and RTAs – 85% of which were described as involving ‘moderate to severe bleeding’.

There were no adverse events for any of the products including those used to treat patients on anticoagulation therapy.

Key Findings

  • 99.3% success rate, 290/292 cases achieved hemostasis after the first application – even those involving the most severe bleeding cases
  • 100% success rate in cases using CELOX Rapid, the most used product
  • 100% success rate on safety: no adverse events reported when using any of the products
  • 99% of respondents across the whole study rated the CELOXTM family of Hemostat Devices ‘good’ or ‘excellent’

Conclusion

Clinical performance of the CELOX range proves to be highly successful in addressing multiple wounds in the hands of multiple clinical personnel controlling moderate to severe bleeding. 99.3% of the survey participants said hemostasis
was achieved after the first application – even in cases involving the most severe bleeding. Every responder using CELOX Rapid said it was 100% successful, and 99% across the survey rated the CELOX family ‘good’ or ‘excellent’ with a 100% safety record; the survey conclusion is a clear endorsement of the effectiveness of CELOX in clinical practice – particularly the highly pressured and demanding environment of the Emergency Department.

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Omni-stat Medical Inc

New York – SoHo – Hudson Square,
101 Avenue of the Americas,
8th and 9th Floors,
New York, NY 10013,
USA

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