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FDA Grants Emergency Use Authorization for Impella RP Right Heart Support in COVID – 19 Related Right Heart Decompensation Including Acute Pulmonary Edema

Background:

  • Impella RP is FDA PMA approved for right ventricular support in acute right heart failure (RHF) associated with left ventricular assist implantation, post heart transplant, early RHF and acute myocardial infarction.
  • Case reports have demonstrated the benefit of RP Impella for acute RHF secondary to pulmonary embolus (PE).
  • Edler et. al. (1) describe 5 patients with acute PE and secondary right heart (RHF) and cardiogenic shock supported by Impella RP. All patients demonstrated a rapid hemodynamic recovery and were discharged alive.

Key Points:

  • COVID – 19 Corona infection, while primarily a respiratory disease, is associated with a high incidence of other morbid conditions including a greater than 20% risk of cardiovascular events.
  • Hypercoagulapathy is a frequent COVID – 19 risk and is often associated with in-situ and thromboembolic pulmonary embolus.
  • As a consequence of respiratory failure and pulmonary emboli, right heart strain and failure is a common finding in COVID – 19 patients.
  • Amir Kaki, associate professor of medicine at Wayne State School of Medicine reported on line a remarkable “save” using RP Impella in a COVID – 19 patient that had acute cardiac collapse from a pulmonary embolus.
  • Kaki stated: “Impella RP is a powerful and effective therapy for RV shock in patients with massive PE”.
  • Based on the risk of RVF and PE in COVID – 19, the FDA issued an
  • Emergency Use Authorization letter supporting RP use in COVID -19 patients:
  • FDA PMA Indication: The Impella RP System is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m, who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.

Emergency Use Authorization: The Impella RP System is authorized to be used by healthcare providers (HCP) in the hospital setting for providing temporary right ventricular support for up to 14 days in critical care patients with a body surface area ≥1.5 m, for the treatment of acute right heart failure or decompensation caused by complications related to Coronavirus Disease 2019

FDA Letter PEUA201027 – Impella RP System Letter of Authorization