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
Ant International Secures Payment Institution Licence from the Central Bank of Brazil4.9.2026 16:41:00 CEST | Press release
Expanding the company’s capability to support local partners with FinAI solutions Ant International, the leading global digital payment, digitisation, and FinAI solutions provider, today announced that it has received a Payment Institution (PI) licence from the Central Bank of Brazil. “With the Central Bank's invaluable support, we are ready to step up more reliable and comprehensive global payment and account services to enterprises, platforms and SMEs in the country's dynamic digital economy, in ever deeper collaboration with its highly developed payments ecosystem and financial services industry,” said Rodrigo Reif, General Manager, Ant International Brazil. Ant International provides cross-border payments and account services, embedded credit and treasury services, and other finAI and blockchain solutions to clients across Asia, Europe and the Americas. The company processes over 20 million transactions daily, connecting 2 billion consumer accounts to 150 million global merchants v
Bending Spoons completes the acquisition of Airtable4.9.2026 14:30:00 CEST | Press release
Bending Spoons S.p.A. (NASDAQ: BSP) has completed the previously announced acquisition of Airtable, the platform used by more than 500,000 organizations to reshape how teams organize data and manage critical workflows. “Airtable continues to grow because customers value its best-in-class flexibility,” said Luca Ferrari, Bending Spoons CEO and co-founder. “Teams can bring all their data, context, and AI agents together in one place, shape their workflows around their specific needs, and progressively expand their use of the platform over time. As we take the reins, our focus will be on sustaining that growth by investing heavily in Airtable’s product, customer support, and go-to-market capabilities.” “I’m proud of what the Airtable team has built and excited to see the business enter this next chapter,” said Howie Liu, co-founder of Airtable. “I’m confident Bending Spoons has the resources and long-term perspective to help Airtable continue delivering exceptional value to its customers
EQT to acquire McGill and Partners, a leading specialty (re)insurance broker for USD 2.0 billion, from Warburg Pincus4.9.2026 13:48:00 CEST | Press release
Warburg Pincus and McGill and Partners have reached an agreement with EQT that will see Warburg Pincus sell its majority stake to EQT McGill and Partners founders, management team and colleagues will re-invest alongside EQT, retaining a meaningful ownership stake in the firm going forward as they continue to serve clients globally Maintains commitment to firm’s independent model and culture of ownership, developed organically since its founding in 2019 EQT will partner with Steve McGill and the management team to accelerate organic growth, including via talent recruitment, further development of technology and data capabilities, and expansion of innovative digital solutions EQT and McGill and Partners are pleased to announce that EQT X ("EQT") has entered into a definitive agreement to acquire a majority stake in McGill and Partners from Warburg Pincus for USD 2.0bn. Founder and Chief Executive Officer Steve McGill will continue to lead the firm, while Chairman John Lloyd will remain a
A Race Is Never Won Alone: With La Tavolata, Barilla Brings the Paddock Family Together on the Monza Grid4.9.2026 12:18:00 CEST | Press release
A nearly 100-meter-long dinner table hosted more than 200 guests for an evening celebrating collaboration, trust and the bonds built beyond competition. On Thursday evening ahead of the Formula 1® Italian Grand Prix, Barilla transformed one of the sport’s fastest and most competitive environments into a place where the Paddock Family took center stage. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260902463001/en/ La Tavolata by Barilla on the starting grid of the Monza circuit. More than two hundred people gathered around a single table: drivers, Team Principals, mechanics, engineers, strategists, safety and medical car drivers, personal trainers, tire technicians. The individuals whose collaboration, precision and trust shape every race, every decision and every performance. A nearly 100-meter table set with plates and pasta. With the first-ever Tavolata organized by Barilla and F1, people from across the Formula 1® ecosy
Aqara Showcases The New Smart Lighting Series and Immersive Smart Home Experience at IFA 20264.9.2026 11:30:00 CEST | Press release
Aqara, a global leader in IoT, today announced a new lineup of smart lighting products and a global community platform for smart space creators, at IFA 2026 in Berlin. The announcements reflect Aqara's ongoing vision for AI-driven spatial intelligence — spaces that understand their users and adapt to how people actually live in them. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260904365343/en/ Aqara Showcases The New Smart Lighting Series and Immersive Smart Home Experience at IFA 2026 The new lighting series — spanning indoor and outdoor use — integrates seamlessly with Aqara's existing ecosystem of sensors, switches, and hubs, bringing complete whole-space lighting scenarios and automated controls to life. The new Aqara products showcased include the Floor Lamp T1, LED Downlight T2, LED Strip T2, Outdoor String Lights H1, and Permanent Outdoor Lights H1. In addition, the company will present Aqara Builder, a platform fo
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