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
Rigaku and Tohoku University Establish a New Research Institute for X-Ray Metrology28.8.2026 17:00:00 EEST | Press release
Rigaku Corporation, a group company of Rigaku Holdings and a global solutions partner for X-ray analytical systems (Head Office: Akishima, Tokyo; President and CEO: Jun Kawakami; “Rigaku”), and Tohoku University (Sendai, Miyagi; President: Teiji Tominaga; “Tohoku University”) have established the Rigaku-Tohoku University Co-Creation Research Institute for X-ray Metrology: Beyond The Limits (the “Institute”) at Tohoku University on August 1, 2026. The Institute will advance X-ray metrology technology, develop new metrology methods, and foster the next generation of researchers through an initial three-year collaboration, with the possibility of extension based on its achievements. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260828688510/en/ Inside the Institute As semiconductors become smaller, more multilayered, and incorporate a wider range of materials, manufacturing processes are becoming increasingly complex. X-ray me
BLK: Portfolio Company of Enry’s Island S.p.A., Lists on Euronext Dublin28.8.2026 16:34:00 EEST | Press release
Enry’s Island S.p.A. (WBAG:EIOS), an international venture builder with headquarters in the Tremiti Islands and the Metaverse, announces that BLK Global PLC, one of the portfolio companies within its ecosystem, has successfully completed its admission to trading on Euronext Access Dublin. Trading in the company’s shares commenced on Friday, July 31, 2026, under ticker BLKX and ISIN GB00BPSKS130. BLK was one of the thousands of applications received by Enry’s Island which, following an assessment process based on the Enry’s Model, was selected for a one-year incubation and acceleration programme. The programme supported the company through its subsequent growth stages, ultimately leading to its current stock market listing. Alessandro Pacciana, Investor Relations Manager of Enry’s Island S.p.A., said: “BLK’s listing is the second stock market listing in two years among Enry’s Island’s portfolio companies, while Enry’s Island itself is the world’s first listed venture builder. We are pro
Zambon Announces European Commission Approval of Hopledo® for Adults with Parkinson's Disease and Moderate to Severe Motor Fluctuations28.8.2026 12:00:00 EEST | Press release
Zambon today announced that the European Commission (EC) has granted marketing authorization for Hopledo® (modified-release levodopa/carbidopa) for the treatment of adult patients with Parkinson’s disease and moderate to severe motor fluctuations who have not been sufficiently stabilized with oral levodopa/dopa decarboxylase (DDC) inhibitor-based treatment regimens. Zambon expects to begin the phased introduction of Hopledo® across European markets starting October 2026. The company is working closely with healthcare authorities and other stakeholders to support timely access for people with Parkinson’s disease who continue to experience moderate to severe motor fluctuations despite current oral therapies. Hopledo® is a first-in-class, oral, modified-release formulation of levodopa/carbidopa (LD/CD) approved for the treatment of motor fluctuations of Parkinson’s disease, the fastest growing neurological condition in the world according to the World Health Organization1. Despite availab
MTG-I2 Safely in Orbit, Unlocking Faster and Sharper Weather Monitoring Across Europe28.8.2026 11:16:00 EEST | Press release
The Meteosat Third Generation Imager 2 satellite (MTG-I2) has successfully passed its first critical post-launch milestones, completing the first full Meteosat Third Generation constellation in orbit. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260828243790/en/ Credit: Arianespace livestream The imager satellite MTG-I2 is safely in orbit and operating as expected following its successful launch yesterday at 22:11 CEST on board an Ariane 6 rocket from Europe’s Spaceport in French Guiana. Our teams have established communication with the spacecraft, which has also deployed its solar panels to ensure its autonomous production of energy. MTG-I2 is in perfect shape to start its Launch and Early Operations Phase that will bring it to a higher orbit, 36 000km above Earth over the following two weeks, where a longer period of calibration and validation of its instruments will begin. This summer’s extreme weather and wildfires hav
New Daiichi Sankyo Data Underscore the Effect of Bempedoic Acid in the Real-World Management of Dyslipidemia and Cardiovascular risk28.8.2026 11:00:00 EEST | Press release
Daiichi Sankyo (TSE:4568) today announced new results from the MILOS study that demonstrate the real-world impact of bempedoic acid administered either alone or as a fixed-dose combination with ezetimibe, in the management of dyslipidaemia. Presented at the European Society of Cardiology Congress 2026 in Munich, the findings show that the clinically relevant reductions in low-density lipoprotein cholesterol (LDL-C) achieved within the first year of treatment are estimated to translate into clinically meaningful reductions in 10-year cardiovascular (CV) risk.1 The data further reinforce the clinical value of bempedoic acid, and its fixed-dose combination with ezetimibe, across a diverse range of patient subtypes, regardless of gender and glycaemic profile (diabetes, pre-diabetes, or normoglycemia).2,3 Key findings from the new analyses of the MILOS study include: 10-year CV risk estimate reduction: An analysis of 960 at-risk patients estimated that one year of bempedoic acid-add-on ther
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