Regulators Approve Impella 5.5 With SmartAssist in Japan and Hong Kong; US FDA Grants Impella BTR Conditional IDE Approval for First-in-Human Early Feasibility Study
10.1.2022 16:02:00 EET | Business Wire | Press release
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 now approved for use in Japan and Hong Kong. (Graphic: Business Wire)
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.
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/20220110005312/en/
Contact information
For further information please contact:
Media Contact:
Tom Langford
Director of Communications
+1 (978) 882-8408
tlangford@abiomed.com
Investor Contact:
Todd Trapp
Vice President and Chief Financial Officer
+1 (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
Frontgrade Expands Executive Team as Demand Grows for Mission-Ready Space and Defense Technologies4.8.2026 18:48:00 EEST | Press release
Frontgrade Technologies Inc. (“Frontgrade”), a leading provider of mission-critical electronics and subsystems, today announced the expansion of its executive leadership team as it continues to invest in the capabilities for the next generation of space, defense, and intelligence missions. Spanning finance, information technology, operations, reputation, go-to-market, and product leadership, the appointments reinforce Frontgrade's commitment to accelerating innovation and helping customers navigate an increasingly complex environment. The six appointments include: Andrew Matsuyama, Chief Financial Officer, brings more than 30 years of finance and business leadership experience during periods of growth and transformation in industrial and technology driven organizations. Most recently he served as CFO for Honeywell Sundyne. Leveraging this experience, Matsuyama will advance Frontgrade’s financial strategy, strengthen its operating foundation, and support continued focus on customers and
Growing with Purpose, Delivering with Impact: ProAmpac Releases 2026 Sustainability Impact Report4.8.2026 18:13:00 EEST | Press release
ProAmpac, a global leader in flexible packaging and material science, announces the release of its 2026 Sustainability Impact Report, centered around the theme Growing with Purpose, Delivering with Impact, the report highlights the company's advancements in sustainable innovation, environmental stewardship, employee safety, and responsible business practices while expanding its global footprint. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260804969765/en/ ProAmpac's 2026 Impact Report is here Reflecting another year of meaningful achievements, the report demonstrates how ProAmpac is embedding sustainability throughout its business, from advancing innovative packaging solutions and reducing environmental impacts to strengthening workplace safety and supporting the communities where employees live and work. Notable achievements highlighted in the 2026 Sustainability Impact Report include: Continued Global Growth: Expanded P
New Esri Press Book Empowers Users to Unlock the Potential of AI with the Power of Geography4.8.2026 17:35:00 EEST | Press release
Esri has released Exploring GeoAI: Tools and Workflows, a practical guide to applying geospatial artificial intelligence (GeoAI) using ArcGIS. Designed for GIS professionals, analysts, and data scientists, this hands-on workbook provides the knowledge and tools needed to integrate advanced AI workflows into real-world spatial analysis. As GeoAI continues to transform how organizations analyze and interpret location-based data, Exploring GeoAI equips readers with the skills to confidently implement deep learning models and workflows. The book guides users through the full GeoAI life cycle—from preparing systems and data to training, evaluating, and deploying models in operational environments. Readers begin by learning how to install and configure deep learning frameworks, assess hardware capabilities, and optimize system performance. From there, they progress through key stages of the GeoAI workflow, including defining project requirements, selecting appropriate data, choosing and trai
Rehlko Defines What It Takes to Build AI-Ready Power Infrastructure as Data Center Energy Demands Evolve4.8.2026 16:15:00 EEST | Press release
Rehlko, a global industrial energy resilience platform providing custom-engineered, integrated power solutions for mission-critical infrastructure worldwide, today released new insights on the power infrastructure requirements emerging from the rapid growth of large language models and artificial intelligence. In its latest eBook, AI Readiness Starts with Power: Designing for Real-World Load Conditions, Rehlko examines how increasingly dynamic AI workloads are reshaping expectations for data center power systems and highlights key infrastructure considerations for operators seeking to scale AI capacity reliably and efficiently. As the eBook outlines, AI readiness is increasingly defined not by installed capacity, but by how systems perform under highly variable real-world load conditions. The AI Power Challenge As investment in AI infrastructure accelerates, data center operators face growing pressure to deploy capacity faster than traditional utility infrastructure can support. At the
HappyRobot Raises $150 Million Series C to Build Enterprise Superintelligence4.8.2026 15:30:00 EEST | Press release
HappyRobot, the company putting AI agents to work across complex enterprise operations, today announced it has raised $150 million in Series C funding led by Prysm Capital and co-led by Eurazeo. Existing investors a16z, Base10, Y Combinator are doubling down with participation from strategics like Koch Disruptive Technologies (KDT), Orange, and T.Capital (Deutsche Telekom), Bankinter, Endeavor Catalyst, Kfund and Wave-X. The round values the company at $1.2 billion post-money, bringing total funding to around $200 million and marking a new stage of growth as enterprises deploy AI agents across mission-critical work. HappyRobot works with more than 150+ enterprise customers, including DHL, Kuehne + Nagel, Naturgy, Repsol, and Uber, and has grown 5x since raising its Series B late last year. After first proving its platform in logistics, one of the world’s most operationally demanding industries, HappyRobot is expanding across the supply chain as well as into insurance, energy and utilit
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