Abiomed’s Impella 5.5 with SmartAssist has received US FDA pre-market approval (PMA) for safety and efficacy in the therapy of cardiogenic shock for up to 14 days. The Impella 5.5 with SmartAssist system is a temporary ventricular support device intended for short term (14 days) use and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (< 48 hours) following acute myocardial infarction or open heart surgery or in the setting of cardiomyopathy.

The intent of Impella system therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function. A press release reports that it has the following features:

  • Minimally invasive, eliminating the need for a sternotomy or coring of the left ventricle
  • Designed for heart surgeons, implanted via the axillary artery or the anterior aorta
  • Forward flow, to provide the patient with coronary flow and renal perfusion
  • Fully unloading, to reduce the heart’s oxygen demand and work
  • Equipped with SmartAssist, designed to provide weaning algorithms to optimize survival and native heart recovery.

Mark Anderson (Heart and Vascular Hospital, Hackensack University Medical Center and Hackensack Meridian Health, Hackensack, USA) says: “A minimally invasive, forward flow, fully unloading heart pump that is designed for surgery is game changing. This gives cardiac surgeons a new and potentially better option that can provide the benefits of heart recovery to some of our sickest patients.”

According to a press release, the inclusion of SmartAssist enables intelligent decision making with weaning algorithms designed to increase survival with heart recovery. SmartAssist also integrates data informatics including left ventricular pressure (LVP), end-diastolic pressure (EDP) and cardiac power output (CPO). The SmartAssist fiberoptic pressure sensor allows for precise pump positioning, management and repositioning in the ICU. Impella Connect enables clinicians to view the Impella control screen through a secure, HIPAA compliant website to track and review cases at any time from any internet-connected device.

The Impella 5.5 with SmartAssist will be introduced in the USA through a controlled rollout at hospitals with established heart recovery protocols. Impella 5.5 with SmartAssist received CE marking approval in Europe in April 2018 and was introduced in Germany through a similar controlled rollout.