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
Croma-Pharma Acquires Synocrom™ and Returns to Orthopaedics8.4.2026 08:00:00 EEST | Press release
Croma-Pharma is returning to the orthopaedics market with the reacquisition of Synocrom™, a hyaluronic acid product for the treatment of knee osteoarthritis. A strategic return built on proven heritage With the reacquisition of Synocrom™, Croma-Pharma is re-entering orthopaedics and further broadening its portfolio in a field with strong historical roots for the company. Until 2014, Croma was active in orthopaedics, with Synocrom™ serving as a key pillar of its offering. Synocrom™ is not a new name in the market. During the period in which Croma actively marketed the product, it became one of the leading hyaluronic acid brands in Europe and ranked among the top brands in its category. Its return therefore represents more than a portfolio expansion: it marks the continuation of a successful orthopaedic legacy and reconnects Croma with an important part of its history. The reintroduction of Synocrom™ also builds on Croma-Pharma’s long-standing expertise in the development and manufacturi
Murata Begins Mass Production of Seven Automotive MLCCs with World-leading Capacitance for Their Rated Voltage and Size, Supporting Stable Operation of In-vehicle Systems and Greater Design Flexibility8.4.2026 05:00:00 EEST | Press release
Murata Manufacturing Co., Ltd. (TOKYO: 6981) (ISIN: JP3914400001) has begun mass production of seven AEC-Q200-qualified multilayer ceramic capacitors (MLCCs) that achieve the world’s largest capacitance for a given rated voltage and size*, supporting stable operation of in-vehicle systems and greater design flexibility. Five parts in the GCM series are rated at 2.5-4 Vdc, targeting IC peripheral circuits in advanced driver assistance systems (ADAS) and autonomous driving (AD) applications. The remaining two MLCCs are rated at 25 Vdc for in-vehicle power line applications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260407486750/en/ [Murata Manufacturing Co., Ltd.] Seven automotive MLCCs In recent years, as ADAS and AD technologies advance, the number and performance level of systems installed in vehicles have continued to increase. As a result, demand for higher capacitance low-voltage MLCCs used around ICs has grown to e
Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)7.4.2026 23:30:00 EEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that Compass granted equity awards under the Compass Pathways plc 2026 Inducement Plan to seven newly hired non-executive employees. The equity awards were granted on April 1, 2026 and consisted of options to purchase an aggregate of 117,445 shares and restricted share units or, in the case of employees in the United Kingdom nominal cost options, covering an aggregate of 55,875 shares. The options have an exercise price per share equal to $5.62, the closing price of the Company’s American Depositary Shares on the Nasdaq Global Select Market on the grant date, and will vest over a four-year period with 25% vesting on the first anniversary of the date of the grant and the remaining 75% vesting in equal monthly installments over the three-year period thereafter, subject to each employee’s continued employment. The restricted s
SLB OneSubsea and Subsea7 Sign Collaboration Agreement with PETRONAS Suriname7.4.2026 23:05:00 EEST | Press release
Global energy technology company SLB (NYSE: SLB) today announced the signing of a strategic collaboration agreement between PETRONAS Suriname E&P B.V. (“PETRONAS Suriname”), a subsidiary of PETRONAS and Subsea Integration Alliance, comprising SLB OneSubsea and Subsea7. This partnership aims to unlock resources in Suriname’s emerging frontier basin through innovative and cost-effective subsea solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260331210557/en/ SLB OneSubsea has signed a strategic collaboration agreement between PETRONAS Suriname E&P B.V. (“PETRONAS Suriname”), a subsidiary of PETRONAS and Subsea Integration Alliance, comprising SLB OneSubsea and Subsea7. This partnership aims to unlock resources in Suriname’s emerging frontier basin through innovative and cost-effective subsea solutions. The agreement establishes a long-term framework for collaboration across the project lifecycle. This approach enables
Nadia Karkar Joins 500 Global as Managing Partner7.4.2026 20:43:00 EEST | Press release
500 Global today announced the appointment of Nadia Karkar as Managing Partner as the firm expands its global investment platform. Nadia’s appointment follows the recent announcement of the appointment of Atul Mehta — former Chief Investment Officer of the International Finance Corporation — to 500 Global's Board of Directors, and reflects the firm's continued build-out of the leadership and capabilities required to deliver on its next stage of global growth. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260407719214/en/ Nadia Karkar Joins 500 Global as Managing Partner Nadia joins from TPG Rise, the $31 billion impact investing platform of TPG Inc., where she most recently served as Head of Business Development, responsible for product innovation, strategic partnerships and corporate development. She played a central role in building TPG Rise Climate’s Global South Initiative, a blended finance vehicle designed to catalyze
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