First Patients, Including a COVID-19 Patient, Treated with Abiomed’s Innovative ECMO Technology
Abiomed (NASDAQ: ABMD) announces the first two patients in the world have been treated with the Abiomed Breethe OXY-1 System, a compact cardiopulmonary bypass system. The advanced ECMO technology pumps, oxygenates, and removes carbon dioxide from blood for patients whose lungs can no longer provide sufficient end organ oxygenation.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201221005403/en/
The first patient in the world treated with the Abiomed Breethe OXY-1 System easily walked around the hospital while on support. (Photo: Business Wire)
The system can help provide oxygenation to patients suffering from cardiogenic shock or respiratory failure from ARDS, H1N1, SARS, or COVID-19. When used with the Impella heart pump, it can unload the heart and oxygenate the body, a combination therapy known as ECpella.
The first patient is a 21-year-old woman at the University of Maryland Medical Center who sustained a lung injury and was placed on V-V ECMO with the Breethe system. She immediately began to improve and was able to ambulate daily, as seen in this short video.
After eight days, the patient was successfully weaned off Breethe support and is no longer in the ICU. The patient was treated by Bartley Griffith, MD, the Hales Distinguished Professor of Surgery at University of Maryland, School of Medicine and Daniel Herr, MD, chief surgical critical care services and medical director cardiac surgery ICU at University of Maryland Medical Center.
The second patient is a 51-year-old woman being treated at HUMC/Hackensack Meridian Health for respiratory failure due to COVID-19. After 24 hours of V-V ECMO support with the Breethe system, she is stable and improving. The patient was treated by Mark Anderson, MD, chief of the division of cardiac surgery and cardiothoracic surgeon at the Heart and Vascular Hospital at HUMC/Hackensack Meridian Health.
“Breethe is an important new option for patients with COVID-19 who require ECMO therapy. It is simple and intuitive to use, highly portable and a very promising therapy with the potential to help many patients,” said Dr. Anderson.
“This revolutionary technology will change the way we think about extracorporeal life support therapy by enabling physicians to easily mobilize their patients in turn promoting a faster recovery,” said Dr. Griffith. “I am pleased to be a part of this milestone as Abiomed continues to advance respiratory and cardiac support to improve patient outcomes.”
“The Breethe system significantly facilitates early mobilization and physical rehabilitation, which is critically important in the recovery of our patients,” said Chris L. Wells, PhD, PT, CCS, ATC, associate professor at the University of Maryland, School of Medicine, EBP, and research coordinator in the department of rehab services at University of Maryland Medical Center. She is also member of the medical team who treated the first patient.
Breethe adds to Abiomed’s innovative portfolio focused on native heart and lung recovery. Abiomed now provides the treatment options of the catheter-based Impella heart pump, which unloads the left ventricle, perfuses end organs and allows the heart to rest and recover, Breethe, which provides oxygenation, and the combination therapy of ECpella, when Impella and Breethe work together to unload the heart and oxygenate the body.
The Breethe system received FDA 510(k) clearance in October. It is being rolled out through a controlled launch at select hospitals in the United States, with full U.S. commercial availability expected in calendar year 2021.
ABOUT ABIOMED
Based in Danvers, Massachusetts, USA, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information, please visit: www.abiomed.com.
ABOUT ABIOMED BREETHE OXY-1 SYSTEM
The Abiomed Breethe OXY-1 System™ is cleared by the U.S. Food and Drug Administration (FDA) to provide extracorporeal circulation. The OXY-1 System pumps, oxygenates and removes carbon dioxide from blood during cardiopulmonary bypass up to six (6) hours in duration.
Under guidance issued by FDA, on April 6, 2020, the Abiomed Breethe OXY-1 System is now permitted to be used temporarily in the U.S. for ECMO therapy greater than six hours. Therefore, it now has a limited indication modification for use longer than six hours in an extracorporeal membrane oxygenation (ECMO) circuit to treat patients who are experiencing acute temporary respiratory or acute cardiopulmonary failure. This limited indication modification for ECMO therapy greater than six hours has not been cleared or approved by FDA and is in effect only for the duration of the public health emergency related to COVID-19 as declared by the U.S. Department of Health and Human Services (HHS).
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements. 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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201221005403/en/
Contact information
Media Contact:
Sarah Karr
Communications Manager
978-882-8211
skarr@abiomed.com
Investor Contact:
Todd Trapp
Vice President and Chief Financial Officer
(978) 646-1680
ttrapp@abiomed.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Blue Shift Report Highlights Systemic Vulnerabilities Caused by the Hidden Cost of AI14.1.2026 11:00:00 EET | Press release
Arthur D. Little’s Blue Shift institute has published its latest report, AI’s Hidden Dependencies. This in-depth report, involving more than 50 experts, explores AI’s resource dependencies and the consequent direct systemic vulnerabilities for businesses and lays out strategic actions in response. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260114966898/en/ Arthur D. Little’s Blue Shift Institute has published its latest report, AI’s Hidden Dependencies With AI’s adoption and usage expected to remain on its growth trajectory, so is its strain on resources. The report notably identifies three main areas of dependency: Environmental impacts, including emissions due to AI’s heavy energy usage and the manufacture of related hardware Energy supply, including increased electricity demand and strain on the grid Compute infrastructure, including supply chain choke points and dependencies on dominant providers As AI is now becomin
Klarna Expands Digital Bank Offer with Peer-to-Peer Payments14.1.2026 10:00:00 EET | Press release
Klarna, the global digital bank and flexible payments provider, has launched instant peer-to-peer payments in 13 European countries, marking the next step in its evolution as a digital bank. The new feature enables Klarna customers to send money to friends and family, whether splitting bills or gifting cash, directly from the Klarna app: as simple as handing someone cash, with the protection of a regulated bank. This launch takes Klarna deeper into everyday banking, turning Klarna into a central hub for day-to-day spending and money management. It comes on the back of the Klarna Balance accounts and the rapid adoption of Klarna Card, with over 4 million sign-ups just four months after launch. Sebastian Siemiatkowski, co-founder and CEO of Klarna commented: “Customers are sick of the friction and fees of traditional banking, which is why millions signed up to Klarna Card within a few months of launch. With peer-to-peer payments we’re making it even easier to manage all of your payments
Northern Trust Secures Expanded Mandate with Swedish Pension Provider AMF Tjänstepension AB14.1.2026 10:00:00 EET | Press release
Northern Trust (Nasdaq: NTRS) today announced that it has retained and expanded its mandate with AMF Tjänstepension AB (AMF), a leading Swedish pension provider. Under the renewed agreement, Northern Trust, which has serviced AMF for more than 20 years, will continue to serve as custodian for AMF’s global pension assets and add investment operations for trade services across AMF’s total portfolio, for both pension and fund company assets. AMF is one of Sweden’s leading pension companies, managing occupational pensions for millions of individuals. With a strong focus on delivering secure and sustainable retirement outcomes, AMF combines cost efficiency with long-term investment strategies to benefit its members. Petra Sjögerås, head of Nordic Region, Northern Trust said: “As a long-standing partner to institutions in the Nordic region, Northern Trust brings extensive experience and a solutions-oriented mindset to proactively support our clients to achieve their goals now and in the futu
Notice Concerning Change of Representative Executive Officer14.1.2026 09:14:00 EET | Press release
H.U. Group Holdings, Inc. (the Company) today announced that it has resolved, at a meeting of the Board of Directors held on January 14, 2026, to change the Company’s Representative Executive Officer as described below. 1. Name and job titles of newly appointed Representative Executive Officer Name New title Current title Goki Ishikawa Representative Executive Officer, President and Group CEO Managing Executive Officer 2. Name and job titles of retiring Representative Executive Officer Name New title Current title Shigekazu Takeuchi Director and Executive Officer Director, Representative Executive Officer, Chairman, President and Group CEO 3. Reason for change In May 2025, toward realizing its Vision for 2035, the Company announced its Medium-Term Management Plan “H.U. 2030” (MMP) as well as its CEO succession plan including the timing for the selection of the next CEO. As the succession plan progressed, the Company has recognized that Mr. Goki Ishikawa is the best to lead the executio
TOXINS 2026: Clinical Updates on Galderma’s Leading Neuromodulator Portfolio Further Reinforce Its Leadership in Injectable Aesthetics14.1.2026 08:00:00 EET | Press release
Galderma (SIX: GALD) will present data on its innovative and industry-leading neuromodulator portfolio at the TOXINS 2026 International Conference in Madrid, Spain from January 14-17, 2026. The company will share data from five abstracts on two neuromodulators from its portfolio, Relfydess – the first and only ready-to-use liquid neuromodulator designed with PEARL Technology – and Dysport. Additionally, Galderma will be hosting a Relfydess Masterclass in which expert speakers will delve into the science and clinical data behind Relfydess. “At TOXINS 2026, we will demonstrate our continued leadership in neuromodulation through updates on our leading portfolio, and an educational session on Relfydess, an innovative, science-backed neuromodulator that delivers advanced performance. As the only company with a portfolio of neuromodulators, we’re building on our heritage in the space by developing next-generation solutions that address the evolving expectations of both patients and practitio
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom