First Patient in Japan Treated with Impella 5.5 with SmartAssist

5,000 Patients Treated Globally

The versatility and innovation of Abiomed’s (NASDAQ: ABMD) Impella 5.5 with SmartAssist, a minimally-invasive forward flow heart pump, is leading to continued adoption of the game-changing technology by surgeons around the world. Today, Abiomed announces the first patient in Japan has been treated successfully with Impella 5.5 with SmartAssist. Additionally, the number of patients treated globally has surpassed 5,000.

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Surgeons at Osaka Police Hospital view a fluoroscopy image showing Impella 5.5 with SmartAssist pumping in the patient’s heart during the first procedure in Japan. (Photo: Business Wire)

The first Impella 5.5 with SmartAssist procedure in Japan took place at Osaka Police Hospital when an 82-year-old man was treated for cardiogenic shock. “Our facility is proud to be the first in Japan to treat patients using Impella 5.5 with SmartAssist,” said Yoshiki Sawa, MD, PhD, director at Osaka Police Hospital. “We are excited to utilize this innovative technology and look forward to providing a minimally invasive surgical option for our acute heart failure patients.”

The milestone 5,000^th procedure was performed by Tamer Attia, MD, at Emory University Hospital in Atlanta on a 41-year-old woman with cardiomyopathy. “Impella 5.5 with SmartAssist has completely changed how we are able to support our cardiogenic shock and cardiomyopathy patients,” said Mani Daneshmand, MD, chief of the section of thoracic transplant and mechanical circulatory support surgery at Emory University Hospital. “Given the safety and efficacy of Impella 5.5 with SmartAssist, Dr. Attia and his team are able to treat patients who otherwise would not have had other options for heart recovery.”

Impella 5.5 with SmartAssist is:

• 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; and
• Equipped with SmartAssist, designed to provide weaning algorithms to optimize survival and native heart recovery.

Additionally, more than 90% of patients are securely monitored in the cloud via Impella Connect, giving providers access to Impella status data 24/7.

Impella 5.5 with SmartAssist, which was granted the highest level of approval for safety and efficacy by the U.S. Food and Drug Administration (FDA) in 2019, is now being used in more than 350 centers across the U.S. for indications that include AMI cardiogenic shock, cardiomyopathy and post-cardiotomy cardiogenic shock. Historically, the cardiogenic shock survival rate has been approximately 50%. Published in Innovations, a study of 200 patients treated with Impella 5.5 with SmartAssist at 42 medical centers in the United States demonstrates a 74% survival to explant, with 58% of those patients achieving native heart recovery.

ABOUT ABIOMED

Based in Danvers, Massachusetts, USA, Abiomed, Inc., is a leading provider of medical devices that provide circulatory support and oxygenation. Our products are designed to enable the heart to rest by improving blood flow and/or provide sufficient oxygenation to those in respiratory failure. For additional information, please visit: www.abiomed.com.

ABOUT IMPELLA HEART PUMPS

The Impella 2.5® and Impella CP® devices are US FDA approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI), such as stenting or balloon angioplasty, to reopen blocked coronary arteries.

Impella 2.5, Impella CP, Impella CP with SmartAssist®, Impella 5.0®, Impella LD®, and Impella 5.5® with SmartAssist® are US FDA approved to treat heart attack or cardiomyopathy patients in cardiogenic shock and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart.

FORWARD-LOOKING STATEMENTS

Any forward-looking statements are subject to risks and uncertainties such as those described in Abiomed's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

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