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Pharmaceutical industry

PharmaNetics Seeks FDA Approval for Ecarin Clotting Time Test Card

Strategic Insights

— 1 min read

PharmaNetics, a Raleigh-based holding company, has submitted an application for Humanitarian Device Exemption (HDE) approval to the FDA for its Ecarin Clotting Time (ECT) test card. This innovative device is designed to monitor the anticoagulant effect of Refludan, a thrombin inhibitor used during cardiopulmonary bypass surgery for patients with heparin-induced thrombocytopenia (HIT). The ECT test card has already been used under a compassionate use exemption, but PharmaNetics seeks formal FDA approval to make it a standard diagnostic tool.

Key Takeaways:

  • The Ecarin Clotting Time (ECT) test card is a diagnostic device developed by PharmaNetics to monitor the anticoagulant effect of Refludan, a thrombin inhibitor used during cardiopulmonary bypass surgery.
  • The current test methods for monitoring Refludan are allegedly inaccurate and unreliable, as stated by Dr. Roger Carillo, a cardiothoracic surgeon at Mt. Sinai Hospital in Miami, Fla.
  • The ECT test card demonstrated its accuracy in a recent case, determining that a patient required additional Refludan to prevent clotting, a diagnosis not available through routine tests.
  • The FDA's Humanitarian Device Exemption (HDE) regulation allows manufacturers to expedite approval for devices that can improve patient outcomes for critical diseases or conditions affecting fewer than 4,000 people in the United States per year.
  • To date, only 10 HDE approvals have been granted by the FDA.
  • Repligen, the manufacturer of Refludan, is Hoechst Marion Roussel.
  • Dr. Roger Carillo of Mt. Sinai Hospital has stated the importance of accurate monitoring of Refludan, particularly in preventing life or permanent disability due to HIT.

Statistics:

  • Only 4,000 people in the United States are affected by heparin-induced thrombocytopenia (HIT) per year.
  • There have been only 10 HDE approvals granted by the FDA to date.
  • The Ecarin Clotting Time (ECT) test card has been used under a compassionate use exemption prior to this HDE application.

Sources:

  • www.pharmanetics.com

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