Main indication for Impella RP was RV failure following LVAD implantation. The EUA indication for the Impella RP system is to provide temporary right ventricular support for up to 14 days in critical care patients with a body surface area of at least 1.5 m2 for the treatment of acute right heart failure or decompensation caused by … The new integrated purge system automatically sets the purge flow to maintain the purge pressure and eliminates the need to actively monitor purge pressures. To clear interference, either increase the distance between system components and the EMI source or turn off the EMI source. Mural thrombus of the right atrium or vena cava. Emergency Use Authorization. Contraindications include biventricular failure or respiratory failure where patients are likely to be better served with extracorporeal membrane oxygenation. Indication: Failure of the right ventricle Step-by-step on-screen procedures allow for quick and simple step-up and purge cassette procedures; featuring automatic priming, detection of connections, and automatic bolus at completion.The Impella RP System is contraindicated for patients with the following conditions: Disorders of the pulmonary artery wall that would preclude placement or correct positioning of the Impella RP device.
Mechanical valves, severe valvular stenosis or valvular regurgitation of the tricuspid or pulmonary valve.
Anatomic conditions precluding insertion of the pump.
Any electromagnetic interference related to the Impella Connect will have no impact on any of the controller functional specifications.During use of the Impella Connect, there will be a delay between when an image appears on the controller screen and when it is displayed at a remote viewing location.The Impella Connect is not a source of patient alarms, nor is its use intended as a replacement for monitoring the controller’s alarms.The Impella 2.5®, Impella CP® and Impella CP® with SmartAssist® Systems are temporary (≤ 6 hours) ventricular support devices indicated for use during high-risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option.
Acute renal dysfunction, Aortic valve injury, Bleeding, Cardiogenic shock, Cerebral vascular accident/Stroke, Death, Hemolysis, Limb ischemia, Myocardial infarction, Renal failure, Thrombocytopenia and Vascular injuryImpella Connect is not intended to provide real-time information for monitoring patient status on the Automated Impella Controller.The Impella Connect is not designed for use during transport.Portable and mobile RF communications equipment can affect medical electrical equipment.The potential adverse effects (eg, complications) associated with the use of the Impella RP System: Arrhythmia, Atrial fibrillation, Bleeding, Cardiac tamponade, Cardiogenic shock, Death, Device malfunction, Hemolysis, Hepatic failure, Insertion site infection, Perforation, Phlegmasia cerulea dolens (a severe form of deep venous thrombosis), Pulmonary valve insufficiency, Respiratory dysfunction, Sepsis, Thrombocytopenia, Thrombotic vascular (non-central nervous system) complication, Tricuspid valve injury, Vascular injury, Venous thrombosis, Ventricular fibrillation and/or tachycardia.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 m2, for the treatment of acute right heart failure or decompensation caused by complications related to Coronavirus Disease 2019 (COVID‐19), including pulmonary embolism (PE).
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 2, who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial … Patients presenting with INTERMACS I had a 30-day survival of 40% whereas patients with INTEMACS 2 or … Use of the Impella 2.5, Impella CP, and Impella CP with SmartAssist Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events. § 360bbb‐3(b)(1), unless the authorization is terminated or revoked sooner.During use of the Impella Connect, receipt of the displayed controller information is not confirmed by the Automated Impella Controller, nor is the delivery of the displayed controller information to the authorized remote users guaranteed.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 m2, who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open‐heart surgery.The Impella RP System is contraindicated for patients with the following conditions: Disorders of the pulmonary artery wall that would preclude placement or correct positioning of the Impella RP device.