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
Nippon Electric Glass’s IR Transmitting Glass “FI-02” Adopted for Heimann Sensor Lens Unit, Enabling a 120° × 68° Field of View16.9.2026 04:00:00 EEST | Press release
Nippon Electric Glass Co., Ltd. (NEG) (TOKYO: 5214), a global leader in specialty glass headquartered in Otsu, Japan, announced that its IR Transmitting Glass (chalcogenide glass) “FI-02” has been adopted for Heimann Sensor GmbH’s wide-angle lens unit for thermal cameras. The lens unit achieves a 120° × 68° field of view, surpassing the previous product’s maximum of 92° × 59°. The adoption marks a significant milestone for FI-02 and showcases how advanced specialty glass can meet the demanding optical and manufacturing requirements of the expanding infrared sensing market. Thermal cameras detect infrared radiation emitted by people or objects and convert it into thermal images. Infrared sensors can detect the locations of people and temperature distributions. They are expected to be used for people detection and monitoring, where privacy considerations are important, and for air-conditioning control, while their use is expanding in healthcare, equipment monitoring, and security. Advanc
Workiva Advances Regulatory Work with AI Innovation15.9.2026 18:00:00 EEST | Press release
Workiva Inc. (NYSE: WK), a leading, audit-ready platform for trust, transparency, and accountability, unveiled dozens of new product and platform innovations at Amplify 2026, the company’s annual conference attended by thousands of finance, accounting, sustainability, risk, and compliance leaders. Workiva Debuts Agent Studio Workiva introduced Agent Studio, a landmark platform capability that empowers users to quickly build, customize, and deploy AI agents in Workiva's trusted platform. By combining AI reasoning with Workiva's native platform capabilities, enterprise knowledge, and governed workflows, Agent Studio enables users to automate sophisticated manual business processes without writing any code. Organizations can enrich agents with company-specific knowledge and context, tailor them to their own processes, and schedule automations to execute recurring work. “With Agent Studio, we're putting the power to build in the hands of the people who know the work and their company the b
Study: Heatwaves Increase Cough Urge, Which Salt Aerosols Reduce15.9.2026 16:15:00 EEST | Press release
SC Therapeutics, with University North Carolina, Imperial College London, and Boston University, announced publication on Tuesday in Nature Scientific Reports of results from a multi-institutional study indicating that the aridity inherent in heatwaves increases cough hypersensitivity in human airways by collapsing mucus onto cilia in a manner common to chronic respiratory diseases, such as cystic fibrosis, and asthma. The researchers find that alkaline aerosols of magnesium salts reverse mucosal collapse for several hours, and reduce cough hypersensitivity as reflected in placebo-adjusted suppression of daily cough bout rate (59%, p=0.03) and persistence of suppression post treatment for 1 to 3 weeks in a randomized, double-blind, placebo-controlled study of 10 refractory chronic cough patients. “Paris recorded 5,764 excess deaths between 17 June and 2 July, a period of time during which we report atmospheric aridity in the city increased approximately 3-fold relative to the 35 year a
ADM’s Fourth Annual Regenerative Agriculture Report Highlights Growing Resilience Across the Food System15.9.2026 16:00:00 EEST | Press release
ADM (NYSE: ADM), a global leader in innovative solutions from nature, today released its fourth annual regenerative agriculture report, showing how its programs are supporting farmers, strengthening agricultural supply chains and delivering measurable environmental outcomes around the world. “Resilience starts on the farm. By improving and protecting soil health, farmers can be better equipped to adapt to changing conditions and maintain productive operations,” said Greg Morris, SVP and President, Ag Services and Oilseeds, ADM. “That resilience can extend across the value chain, helping strengthen the food system we all depend on.” In 2025, ADM’s regenerative agriculture programs engaged more than 56,000 farmers across approximately 4.6 million acres, 11 countries and 10 crops. Compared with regional benchmarks, the programs resulted in approximately 946,000 metric tons of CO₂e reductions. “ADM views agriculture as a powerful way to meet evolving customer needs, and our work in regener
Diligent Unveils New Agentic Capabilities in Diligent One to Power the Future of Governance, Risk and Compliance15.9.2026 16:00:00 EEST | Press release
Diligent, the AI leader in governance, risk and compliance (GRC) solutions, today announced a major enhancement to Diligent One, its native AI platform, at Gartner’s Enterprise Risk, Audit and Compliance Conference (ERAC). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260915941016/en/ “For many organizations, GRC work is slowed by fragmented systems, manual coordination and time-consuming reporting processes,” said Brian Stafford, President and CEO of Diligent. “Our latest agentic capabilities help teams cut through that complexity by connecting context, surfacing what matters and driving faster execution — while keeping governance and professional judgement at the center." An orchestration agent that coordinates work and approvals The orchestration agent in Diligent One gives GRC professionals a natural-language interface to coordinate audit and risk work. Instead of simply answering questions, it enables users to describe
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