MA-ABIOMED
10.1.2022 14:04:04 CET | 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 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
Hightouch Partners with Independent Media to Activate Reader and Commercial Data27.10.2026 17:01:00 CET | Press release
The partnership will help Independent Media deliver more relevant reader engagement, build premium advertising audiences, and support affiliate and e-commerce growth. Hightouch, the leading agentic marketing platform, today announced a partnership with Independent Media, publisher of The Independent. Independent Media will use Hightouch to connect its customer data to marketing tools. With Hightouch, the company will send readers more relevant membership and subscription offers, build stronger audiences for its advertising partners, and grow its affiliate and e-commerce business. “Deepening customer relationships and delivering real value to our commercial partners requires moving seamlessly from insight to action,” said Krishan Gandhi, Director of Data Intelligence and Monetisation at Independent Media. “Partnering with Hightouch allows us to utilise our warehouse data directly into our engagement tools, powering real-time, omnichannel journey orchestration, while enabling us to build
IFF Identifies Ten Consumer Moments Reshaping Food and Beverage Innovation in the GLP-1 Era27.10.2026 16:00:00 CET | Press release
New research reveals how smaller, more intentional eating occasions are creating new opportunities for nutrition, flavor and renewed enjoyment. IFF (NYSE: IFF)—a global leader in flavors, fragrances and health and biosciences, today launched its latest report, “GLP-1 Consumer Moments of Opportunity.” The report uncovers ten emerging consumer moments that reflect the changing needs of consumers using GLP-1 medications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261026614988/en/ New report from IFF uncovers ten emerging consumer moments that reflect the changing needs of consumers using GLP-1 medications. “What GLP-1 users need from food and beverage products depends on the moment, and those needs can change many times throughout the day,” said Yuvraj Arora, president of IFF Taste. “The most successful innovations will be designed around the occasions that matter most to consumers, delivering the right balance of nutrition
Phison Receives Micron Global Supplier Awards27.10.2026 15:00:00 CET | Press release
Phison Electronics (8299TT), a global leader in NAND flash controllers and storage solutions, is honored to announce that it was presented with Outstanding Supplier Performance Awards in the Semiconductor category and the Best in Quality – Assembly and Test categoryat the Micron Supplier Day 2026. The event, held in Boise, Idaho, United States was attended by top-level management of Micron and its suppliers, including Phison. The awards highlight our commitment to excellence in quality, innovation and collaboration with Micron, a global leader in semiconductor memory and storage. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261027158504/en/ Phison wins Outstanding Supplier Performance Award in Semiconductor category and the Best in Quality – Assembly and Test category at the Micron Supplier Day 2026 “Receiving our third Micron Supplier Award in a row is a tremendous honor and a testament to the strength of our partnership
MUFG Investor Services Appoints McAllister Kirschner Chief Executive Officer27.10.2026 14:15:00 CET | Press release
MUFG Investor Services today announced the appointment of McAllister (Mac) Kirschner as Chief Executive Officer, effective immediately. John Sergides has stepped down as Chief Executive Officer of MUFG Investor Services for health-related reasons. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261027545977/en/ McAllister (Mac) Kirschner Appointed Chief Executive Officer of MUFG Investor Services Kirschner has served as Chief Operating Officer of MUFG Investor Services since 2018, overseeing business and banking operations across public and private markets. He joined MUFG Investor Services in 2016 and previously served as Global Head of Relationship Management, bringing extensive knowledge of the business, its clients, and operations. Before joining MUFG Investor Services, Kirschner was a Managing Director in BlackRock’s Global Fund Services business, where he led teams responsible for shareholder servicing, fund administrati
FEINDEF 27 Has Already Booked 94% of Its Exhibition Space Seven Months Ahead of the Event27.10.2026 14:03:00 CET | Press release
The International Defence and Security Exhibition of Spain (FEINDEF 27) has booked 94% of its exhibition space for 18 to 20 May 2027 at IFEMA Madrid, reflecting strong demand and interest among companies and institutions across the sector. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261027170443/en/ Ángel Olivares, President of the Feindef Foundation Fundación Feindef announced the figure on Monday at the official presentation of the exhibition's fifth edition, held at Madrid's Rafael del Pino Auditorium. The fair is expected to cover more than 89,000 square metres, 46% more than in 2025. More than 746 exhibitors have been confirmed, up 19% on the previous edition. Of these, 37% are first-time participants and over 250 are international exhibitors, accounting for 33% of the total. The event will feature 14 international pavilions, strengthening its international reach as the defence and security industry gains prominence
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