MA-ABIOMED
Regulators in three countries have granted approvals to Impella surgical products, as Abiomed (NASDAQ: ABMD) continues to execute its strategy for sustainable growth with new products, new indications and new geographies. In the United States, the Food and Drug Administration (FDA) has granted an Early Feasibility Study (EFS) Investigational Device Exemption (IDE) to Impella BTR (Bridge-to-Recovery). In Asia, Impella 5.5 with SmartAssist has received approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and Hong Kong’s Medical Device Division (MDD).
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220110005312/en/
Impella 5.5 with SmartAssist is a game-changing technology for patients in Japan and Hong Kong. It is a minimally invasive, forward flow, fully unloading heart pump designed by and for heart surgeons with direct or axillary insertion. It received FDA post-market approval (PMA) two years ago. Since then, it has been used to treat more than 4,000 US patients for indications that include AMI cardiogenic shock, cardiomyopathy and post-cardiotomy cardiogenic shock. Historically, the cardiogenic shock survival rate has been approximately 50%. Impella 5.5 with SmartAssist patients have a 74% survival to explant, with 59% of surviving patients achieving native heart recovery.
In Japan, Impella 5.5 with SmartAssist is now indicated for use in the treatment of drug-resistant acute heart failure attributable to causes such as cardiogenic shock. The first Impella 5.5 with SmartAssist patient in Japan is expected to be treated in the coming months.
“The Japanese market is ideal for Impella 5.5 with SmartAssist because the technology provides minimally invasive, longer-term unloading support, enabling native heart recovery in a country that is more resistant to invasive sternotomies and heart transplants,” said Michael R. Minogue, Abiomed’s Chairman, President and Chief Executive Officer.
In the United States, the FDA has approved the Impella BTR early feasibility IDE study, clearing the way for the first patient in the world to be treated with Impella BTR. Impella BTR is a percutaneous heart pump, with greater than six liters of blood flow per minute. It is designed to be much less invasive than current LVADs.
The vision of the Impella BTR development program is to provide a patient with home discharge and up to one year of full hemodynamic support. In the early feasibility study, ten patients will be enrolled at up to five hospitals and supported by Impella BTR for up to 28 days. The first Impella BTR patient is expected to be treated in March or April this year.
“The FDA’s approval is a first step toward making this longer-term minimally invasive forward flow smart heart pump a reality for patients with chronic heart failure,” said Minogue.
Impella BTR is an investigational device, limited by federal law to investigational use only.
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.
Impella BTR® is an investigational device, limited by federal law to investigational use only.
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 .
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220110005312/en/
Social Media:
About Business Wire
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
Ahead of Holiday Season, Visa Identifies Five Transformative Forces Reshaping Global Payment Security20.11.2025 19:50:00 CET | Press release
New Biannual Threats Report Reveals Fundamental Shift in Fraud Operations as Criminals Adopt Industrial-Scale Tactics To celebrate International Fraud Awareness Week, Visa (NYSE: V) today released its Fall 2025 Biannual Threats Report, revealing five forces that are transforming the global payments security landscape. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251120412198/en/ The report, produced by Visa's Payment Ecosystem Risk and Control (PERC) team, draws on intelligence from Visa's global network to identify how criminal operations are evolving with unprecedented speed, scale, and sophistication. "The payments ecosystem is experiencing a paradigm shift in how fraud operates," said Paul Fabara, Chief Risk and Client Services Officer at Visa. "Criminals are no longer working as opportunistic individuals-- they're operating like tech startups, building reusable infrastructure and deploying systematic, industrial-scale
Suzano Forms Partnership with Tencent and Ecofuturo Institute at COP30 for AI-Powered Conservation and Nature Education20.11.2025 18:25:00 CET | Press release
New agreement signed at COP30 will see organisations collaborating to use artificial intelligence tools for biodiversity monitoring and digital platforms to boost public engagement in conservation efforts. The world’s largest pulp supplier, Suzano, today announces the signing of a Memorandum of Understanding (MoU) with the multinational technology business Tencent and the Brazilian non-profit Ecofuturo Institute, to pioneer new digital approaches to drive public engagement in conservation. The collaboration will leverage Suzano’s expertise in sustainable forestry, Tencent’s cutting-edge digital technology, and Ecofuturo’s expertise in environmental education, to pilot joint initiatives in both Brazil and China. These include enhancing ecological awareness, accelerating biodiversity solutions, and leveraging digital platforms to foster public engagement in conservation. The partnership will result in a pilot project where advanced AI tools for species recognition developed by Tencent’s
EMVCo Working on How Global Specifications Can Support Agentic Payments20.11.2025 17:38:00 CET | Press release
EMVCo – the technical body that creates and manages EMV® Specifications and programmes that enable seamless and secure card-based payments worldwide – has announced that it is working on how global specifications can support innovation in agentic payment solutions by increasing trust and interoperability across the ecosystem. Agentic commerce is rapidly reshaping the shopping experience by enabling AI agents to act on the consumer’s behalf. This is driving significant momentum for agentic payments, which introduce AI agents as new actors that can initiate transactions with merchants – without requiring direct involvement from the consumer. While agentic payments have the potential to increase convenience and personalisation, they present unique considerations for how transactions are initiated, authenticated and secured. As industry adoption and innovation accelerate, a globally interoperable and scalable approach may be beneficial in realising trusted agentic payments for consumers, m
Université Paris-Saclay and Owkin: A Unique Alliance to Propel University Medical Research to the Top of the European Rankings Through AI20.11.2025 15:17:00 CET | Press release
Université Paris-Saclay and Owkin announce the signing of a memorandum of understanding to explore the potential of K Pro Free - Owkin’s AI co-pilot for biology - for use by Paris-Saclay. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251120130113/en/ K Pro Free will now be available to the entire Université Paris-Saclay community, and in particular teachers, researchers and doctoral students working in the biomedical sciences. The partnership includes workshops, training sessions and events designed to promote the discovery and adoption of K Pro Free, as well as the co-organization of communication and dissemination initiatives around the use of AI in health. In this way, the partnership will promote user training, but also enrich and continuously improve the co-pilot's models through feedback and use cases from the l’Université Paris-Saclay community. This partnership is part of Université Paris-Saclay’s strategy to integr
Frasca Advances Flight Training Technology with New Visual System Powered by Unreal Engine20.11.2025 15:05:00 CET | Press release
Frasca International, Inc., a FlightSafety International company and leader in flight simulation, today announced the launch of VITAL FVS 100, the next evolution of its visual system technology. Building on the proven TruVision Global platform, VITAL FVS 100 was developed using Epic Games’ Unreal Engine and delivers unprecedented realism, scalability, and innovation in pilot training. The Unreal-powered VITAL FVS 100 system introduces major advancements in visual fidelity and training realism, further enhancing the capabilities of Frasca, a leading developer of flight simulators and training devices. The new system includes physically based renderings, advanced lighting effects, and a new volumetric cloud model that creates dynamic, weather-rich environments. Terrain imagery now includes one-meter resolution coverage for the contiguous United States and Hawaii, with expanded global datasets covering European buildings and tree covered regions. Additionally, enhanced particle effects re
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