October 31, 2019

Abiomed Begins Controlled Rollout of Impella 5.5 With SmartAssist in the United States

October 31, 2019—Abiomed, Inc. announced that the Impella 5.5 with SmartAssist, a forward flow heart pump, is being introduced in the United States through a controlled rollout at hospitals with established heart recovery protocols. The company noted that the first United States patients have been treated with the device.

In September 2019, the company announced that the Impella 5.5 with SmartAssist received FDA approval for safety and efficacy in the therapy of cardiogenic shock for up to 14 days. The device received European CE Mark approval in April 2018 and was introduced in Germany through a similar controlled rollout.

The minimally invasive Impella 5.5 with SmartAssist is a temporary heart pump that eliminates the need for a sternotomy or coring of the left ventricle. Implanted via the axillary artery or the anterior aorta, the system features include:

  • Forward flow to provide patients with coronary flow and end organ perfusion
  • SmartAssist, which is designed to provide weaning algorithms to optimize survival and native heart recovery
  • A motor housing that is thinner and 45% shorter than the Impella 5.0, which improves ease of pump insertion through the vasculature

The system is also fully unloading to reduce the heart’s oxygen demand and work, and it delivers peak flows of > 6 L/min.

The first cardiac surgeons in the United States to implant the Impella 5.5 with SmartAssist are Ed Soltesz, MD, at Cleveland Clinic in Cleveland, Ohio; Mark Anderson, MD, at Hackensack Meridian Health in Hackensack, New Jersey; and Danny Ramzy, MD, at Cedars-Sinai Medical Center in Los Angeles, California. They have each implanted multiple pumps during cardiac procedures at their hospitals.

Dr. Anderson commented in the company’s announcement, “The Impella 5.5 is a promising new option for heart failure patients in cardiogenic shock. It is easy to implant through the axillary artery to avoid opening the chest or, if the chest is already open during a surgical procedure, it can be implanted directly into the anterior aorta. Additionally, with SmartAssist, I can monitor the left ventricle function of my patient in real time in the intensive care unit.”


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