Entegrion Viscoelastic Coagulation Monitor Receives FDA Breakthrough Device Designation
VCM Receives FDA Breakthrough Designation for Assessing Preterm Neonates
Entegrion Viscoelastic Coagulation Monitor (VCM) to be Used to Assess Coagulation Status from Whole Blood of Preterm Neonates Aged 28 or More Weeks, Full Term and Newborns up to Six Months Post-Birth
The US Food and Drug Administration (FDA) – also responsible for regulating the sale of medical device products in the U.S. – has given Breakthrough Device Designation to the Entegrion Viscoelastic Coagulation Monitor (VCM). The Breakthrough Device Designation allows Entegrion to work collaboratively with the FDA to develop the first-in-class diagnostic solution for assessing coagulopathies in neonates.
The medical device will be used to assess coagulation status using native whole blood collected via standard venipuncture or heel sticks from preterm neonates older than 28 weeks, full-term neonates, and newborns up to six months post-birth. The Entegrion VCM can play an important role in helping support clinical decision-making by providing a quick and accurate, easy-to-use device for monitoring hemostasis at patients’ bedside.
Providing clinicians with diagnostic tools that simplify the monitoring of high-risk neonatal patients is crucial to improving outcomes during the early weeks of life.
When the marketing authorisation application is approved “Entegrion will offer for the first time in the United States a diagnostic test specific to this extremely vulnerable patient population.” said Bert Valada, President and CEO of Entegrion. “Our whole blood heel stick diagnostic test gives the caregiver a global understanding of a neonate hemostasis condition patient side.”
How Does a Viscoelastic Coagulation Monitor Work?
Entegrion’s VCM has a three-step operation that allows samples to be run anywhere at any time with results within minutes:
1. Add 300 microliters of whole blood patient sample directly from syringe to the sample collection well. No sample preparation or pipetting is required.
2. Remove the sample cup and insert the cartridge into the VCM Analyzer.
3. Review. Within Minutes of inserting the testing cartridge into the VCM, your results will begin to be displayed on the VCM touch screen.
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