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Novel Viscoelastic Coagulation Monitor (VCM) May Aid in Assessing Neonatal Hemostasis, Support Individualized Treatment

VCM Analyzer

VCM results could support a more rational and tailored platelet administration reducing adverse effects and improving patient outcomes

The VCM has promising clinical applications. It uses a small amount of native blood and is particularly suitable for the NICU setting. ”
— Dr. Stefano Ghirardello, Principal investigator

DURHAM, NORTH CAROLINA, USA, October 5, 2021 / -- Entegrion, Inc., a leading developer of innovative solutions for clinical diagnosis and management of hemostasis, highlighted a newly released publication of a case study demonstrating the clinical value of its portable Viscoelastic Coagulation Monitor (VCM) in assessing individual bleeding risk. In the study, accepted for publication in Children, an international peer reviewed journal on pediatrics, investigators from Fondazione Ca’ Granda Ospedale Maggiore Milano, Italy looked to assess individualized bleeding risk through viscoelastic coagulation monitoring (VCM) and thromboelastography. The Entegrion VCM has a CE mark for use in Europe and is available for research use only in the U.S.

The publication of the case study on May-Hegglin Anomaly in preterm twin neonates identifies the potential risks of hemorrhagic complications due to low platelet count and the potential for reducing risks and improving outcomes through the use of viscoelastic coagulation monitoring. “The VCM has promising clinical applications,” stated Dr. Stefano Ghirardello, Principal investigator and Director of Neonatology and Neonatal Intensive Care at the Fondazione IRCCS Policlinico San Matteo, Pavia, Italia. “It uses a small amount of native blood and is particularly suitable for the NICU setting. This would especially benefit patients at a higher risk of bleeding”.

“Providing clinicians with diagnostic tools that support the monitoring of high risk patients is crucial to improving outcomes,” said Dr. Christopher Rumana, Chairman of the Board for Entegrion. “The recent study from Italy showed how the Entegrion VCM can play a significant role in helping support clinical decision-making with a quick and accurate, easy-to-use device for monitoring hemostasis at patient’s bedside”.

About the Viscoelastic Coagulation Monitor (VCM)
The Entegrion VCM is a compact, portable device that performs a viscoelastic analysis of the coagulation-fibrinolysis process utilizing glass surface activation of untreated whole blood. The wide surface area of contact between the blood and the glass inside the cartridge accounts for the rapid initiation of clotting, eliminating the need for activating factors. VCM has been compared to ROTEM® NATEM (non-activated method), showing good-to-moderate agreement in test results between the two systems in a cohort of patients undergoing major surgery.1 By making viscoelastic measurements of the hemostasis of blood samples rapidly and accurately, the VCM system addresses the accessibility, robustness and training issues associated with large, complex, traditional systems.

About Entegrion
Entegrion is a life sciences development company that is focused on improving clinicians’ ability to manage hemostasis in their patients. Based in North Carolina’s Research Triangle Park, its patented technologies are designed to overcome limitations in storage, safety, and availability of blood-derived products while improving their functionality. Many of Entegrion’s advances in biologics are based on close collaborations with leading medical research institutions. Visit for more information.

1. Brearton C, Rushton A, Parker J, Martin H, Hodgson J. Performance Evaluation of a New Point of Care Viscoelastic Coagulation Monitoring System in Major Abdominal, Orthopaedic and Vascular Surgery. Platelets. 2020;1–8.
2. Amodeo, I.; Raffaeli, G.; Vianello, F.; Cavallaro, G.; Cortesi, V.; Manzoni, F.; Amelio, G.S.; Gulden, S.; Mosca, F.; Ghirardello, S. Individualized Bleeding Risk Assessment through thromboelastography: A Case Report of May–Hegglin Anomaly in Preterm Twin Neonates. Children 2021, 8, 878.

Bert Valada
Entegrion, Inc.
+1 919-536-1500
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