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September 26, 2019

FDA Grants Premarket Approval for Abiomed's Impella 5.5 With SmartAssist

September 25, 2019—Abiomed, Inc. announced it has received FDA premarket approval (PMA) for its newest heart pump, the Impella 5.5 with SmartAssist, for safety and efficacy in the therapy of cardiogenic shock for up to 14 days.

According to the company, the Impella 5.5 with SmartAssist is minimally invasive, which eliminates the need for a sternotomy or coring of the left ventricle; has forward flow to provide patients with coronary flow and renal perfusion; and is fully unloading to reduce the heart’s oxygen demand and work. Abiomed also describes this new version as designed for heart surgeons with implantation via the axillary artery or the anterior aorta.

“A minimally invasive, forward flow, fully unloading heart pump that is designed for surgery is game-changing,” said Mark Anderson, MD, in the company’s announcement. “This gives cardiac surgeons a new and potentially better option that can provide the benefits of heart recovery to some of our sickest patients.” Dr. Anderson is Chief of the Division of Cardiac Surgery and cardiothoracic surgeon at the Heart and Vascular Hospital at Hackensack University Medical Center and Hackensack Meridian Health, in Hackensack, New Jersey.

“The Impella 5.5 is designed to give severely ill patients the best chance for recovery of the heart," commented Hermann Reichenspurner, MD, PhD, in the company’s press release. “A forward flow, minimally invasive heart pump that unloads the left ventricle and perfuses the end organs adequately is an ideal tool to help stabilize a patient after cardiac decompensation and give the heart time to rest and recover.” Prof. Reichenspurner is Chief of the Department of Cardiovascular Surgery, at University Heart Center Hamburg, in Hamburg Germany.

Abiomed also noted that the Impella 5.5 with SmartAssist delivers peak flows of > 6 liters per minute. A motor-housing that is thinner and 45% shorter than the Impella 5.0 improves ease of pump insertion through the vasculature.

As described in the press release, the SmartAssist feature allows weaning algorithms to optimize survival and native heart recovery. SmartAssist integrates data informatics including left ventricular pressure, end-diastolic pressure, and cardiac power output. The fiberoptic pressure sensor of the SmartAssist allows for precise pump positioning, management, and repositioning in the intensive care unit.

Abiomed advised that the Impella 5.5 with SmartAssist will be introduced in the United States through a controlled rollout at hospitals with established heart recovery protocols. The Impella 5.5 with SmartAssist received CE Mark in Europe in April 2018 and was introduced in Germany through a similarly controlled rollout.

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