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
1NCE and Netmore Combine Cellular and LoRaWAN Access to Deliver Global IoT Coverage11.3.2026 09:40:00 EET | Press release
1NCE, a company offering a plug-and-play platform for creating and managing the world’s best IoT products, today opened access for its customers to the LoRaWAN® services of Netmore, the world’s leading low power wide area network operator for massive IoT. With growing demand for low power long range connectivity, the Netmore LoRaWAN Network Server (LNS) Plugin provides 1NCE customers access to cellular and LoRaWAN IoT coverage options through one platform. The launch of the Netmore Plugin marks the beginning of strategic collaboration to expand the combined offering of the two biggest massive IoT network specialists — 1NCE, the biggest private IoT network in the cloud and Netmore, the largest LoRaWAN network and platform provider in the world. 1NCE’s software and connectivity platform has become a new industry standard. Working together to support their respective customer bases with both cellular and LoRaWAN technology delivers a powerful layer of redundancy to cover the hardest to re
1NCE and Netmore Combine Cellular and LoRaWAN Access to Deliver Global IoT Coverage11.3.2026 09:40:00 EET | Press release
1NCE, a company offering a plug-and-play platform for creating and managing the world’s best IoT products, today opened access for its customers to the LoRaWAN® services of Netmore, the world’s leading low power wide area network operator for massive IoT. With growing demand for low power long range connectivity, the Netmore LoRaWAN Network Server (LNS) Plugin provides 1NCE customers access to cellular and LoRaWAN IoT coverage options through one platform. The launch of the Netmore Plugin marks the beginning of strategic collaboration to expand the combined offering of the two biggest massive IoT network specialists — 1NCE, the biggest private IoT network in the cloud and Netmore, the largest LoRaWAN network and platform provider in the world. 1NCE’s software and connectivity platform has become a new industry standard. Working together to support their respective customer bases with both cellular and LoRaWAN technology delivers a powerful layer of redundancy to cover the hardest to re
Codethink Opens Early Access to IEC 61508 Mapping for the Eclipse Trustable Software Framework11.3.2026 09:07:00 EET | Press release
EMBEDDED WORLD--Codethink today opened early access to its mapping between the Eclipse Trustable Software Framework (TSF) and IEC 61508, the international standard governing the functional safety of electrical and electronic systems. The mapping establishes a transparent relationship between the engineering principles of the Trustable Software Framework and the objectives defined in IEC 61508. By making this work available as an early preview, Codethink is inviting organisations interested in applying open source approaches to functional safety to review and begin working with the mapping while the work continues to mature. IEC 61508 forms the foundation of many domain-specific safety standards, including ISO 26262 for automotive systems. The early access reflects Codethink’s long-standing commitment to open development of software engineering methods. “This preview release reflects our belief that trust in software must be engineered in the open," said Paul Sherwood, Codethink’s Chair
FERM FOOD Acquires Orkla’s Former Site and Scales Up: Up to 20,000 Tonnes of Fermented Ingredients Per Year11.3.2026 08:00:00 EET | Press release
Danish ingredient producer FERM FOOD is acquiring Orkla’s former manufacturing site in Skovlund, Denmark, effective 1 April 2026. The acquisition provides new production facilities to expand the output of fermented plant-based ingredients for the food industry — driven by export demand that has emerged faster than expected. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260310904877/en/ Jens Legarth (CEO), Rikke Matthiesen (CSO), and Torbjørn Tyndkjær-Thomsen (Food & Process Developer) at FERM FOOD’s new production facilities. “We have outgrown our current facilities. With the Skovlund site, we can supply many more food manufacturers in Denmark and abroad. Global interest has developed faster than we expected — and that is why we are scaling up now,” says Jens Legarth, CEO of FERM FOOD. Once fully ramped up, the new fermentation facility is expected to reach an annual capacity of up to 20,000 tonnes, depending on product mix
Galderma Buys Back Shares Worth CHF 232 Million in the Context of Accelerated Bookbuild Offering11.3.2026 08:00:00 EET | Press release
Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that it has agreed to repurchase 1.6 million shares at a price of CHF 143.75 per share for a total consideration of CHF 232 million in the context of the accelerated bookbuild offering (“ABO”) of Galderma shares by Sunshine SwissCo GmbH (“EQT”), Abu Dhabi Investment Authority (Private Equities Department) and Auba Investment Pte. Ltd. (all together the “Selling Shareholders”) launched yesterday evening. The repurchase was made at the same price per share determined by the bookbuilding offering. As a result of yesterday evening’s ABO, the Selling Shareholders have fully divested their remaining stake in Galderma. The repurchase, which is expected to settle on March 13 is being financed by Galderma’s existing liquidity on hand and will not affect the company’s ability to deliver on its strategic and financing priorities. The shares will be held in treasury for future use in connection with Galderma's employe
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