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July 1, 2020

Findings Published From Initial United States Experience With Abiomed Impella 5.5 With SmartAssist

July 1, 2020—Abiomed announced the publication of findings from the initial United States commercial experience with the company’s Impella 5.5 heart pump with SmartAssist. The study by Danny Ramzy, MD, Edward Soltesz, MD, and Mark Anderson, MD, was published in the July edition of the American Society for Artificial Internal Organs’ ASAIO Journal (2020;66:746-752).

Abiomed’s Impella 5.5 with SmartAssist is a microaxial, surgically implanted, temporary heart pump that unloads the left ventricle, reduces ventricular work, and provides the circulatory support necessary to allow native heart recovery and early assessment of residual myocardial function.

The study examined the outcomes of the first 55 patients treated with Impella 5.5 with SmartAssist at Cedars-Sinai Medical Center in Los Angeles, California; Cleveland Clinic in Cleveland, Ohio; and Hackensack University Medical Center/Hackensack Meridian Health in Hackensack, New Jersey.

Dr. Ramzy is Assistant Professor, Surgical Director of the Lung Transplant Program, and Director of Robotic and Minimally Invasive Cardiac Surgery at Cedars-Sinai Medical Center. Dr. Soltesz is a cardiac surgeon in the Department of Thoracic and Cardiovascular Surgery at Cleveland Clinic. Dr. Anderson is a cardiac surgeon in the Department of Cardiothoracic Surgery at Hacksensack University Medical Center.

In October 2019, the company announced that the Impella 5.5 with Smart Assist was being introduced in the United States through a controlled rollout at hospitals with established heart recovery protocols. In September, the device received FDA premarket approval for safety and efficacy in the therapy of cardiogenic shock for up to 14 days.

According to Abiomed, the 55 patients in the study were implanted with Impella 5.5 with SmartAssist between October 16, 2019, and March 4, 2020. The investigators reported the following:

  • 35 patients (63.6%) were successfully weaned off the technology.
  • 11 patients (20%) went on to receive another therapy, two patients (3.6%) died while on support, and seven patients (12.7%) had care withdrawn.
  • 76.1% of survivors recovered native heart function.
  • There were no device-related strokes, hemolysis, or limb ischemia observed.

The results demonstrated that the device provides dependable acute mechanical circulatory support for patients who need it by stabilizing their hemodynamics during treatment. The investigators concluded that Impella 5.5 with SmartAssist is safe and effective for a number of challenging clinical scenarios, including acute myocardial infarction cardiogenic shock.

Dr. Ramzy commented in the company’s announcement, “This report demonstrates the benefit of unloading cardiogenic shock patients, and it is encouraging to see real-world data demonstrate improved survival rates with use of Impella 5.5 with SmartAssist. The continued use of best practices, techniques, and innovative technology like Impella allows us to provide better patient care that improves outcomes and quality of life.”

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