MA-ABIOMED
The United States Food and Drug Administration (FDA) has granted breakthrough device designation to Abiomed ’s (NASDAQ: ABMD) Impella ECP expandable percutaneous heart pump. The designation means the FDA will prioritize Impella ECP’s regulatory review processes including design iterations, clinical study protocols and pre-market approval (PMA) application.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210818005373/en/
Impella ECP is the smallest heart pump in the world and the first to be compatible with small bore access and closure techniques. It measures 9 French (3 millimeters) in diameter upon insertion and removal from the body. While in the heart, it expands to support the heart’s pumping function, providing flow greater than 3.5 L/min.
The FDA granted breakthrough device designation in part based on positive clinical data from the first 21 Impella ECP patients treated as part of an FDA regulated early feasibility study. In granting the designation, the FDA determined Impella ECP meets the FDA’s stringent requirements for a breakthrough device .
“This is yet another validation from the FDA of the clinical benefits of Impella technology and an affirmation of the innovative nature of Impella ECP which, due to its smaller vascular access size, has the potential to provide even safer procedures and be available to more patients who need hemodynamic support for coronary revascularization,” said Chuck Simonton, MD, Abiomed’s chief medical officer.
In the United States, an estimated 440,000 patients are indicated and yet undertreated for high-risk PCI. Impella ECP’s size may enable more physicians to provide critical hemodynamic support to coronary artery disease patients who need it.
The first Impella ECP patient in the world is Robert Matthews, an 80-year-old retired auto worker from Detroit, a father of four, and grandfather of eleven. For more than 20 years, Robert lived with heart disease and endured multiple procedures. In 2020, he was referred to Amir Kaki, MD, an interventional cardiologist and director of mechanical circulatory support at Ascension St. John Hospital in Detroit. Dr. Kaki discovered multiple blockages and poor heart function and identified Robert as an appropriate candidate for a Protected PCI with Impella. Robert became the first patient in the world treated with Impella ECP when Dr. Kaki inserted the heart pump prior to opening blockages and placing stents.
Two days later, Robert returned home, and his family and friends immediately noticed his renewed energy. Today, Robert is grateful for the cutting-edge technology that restored his quality of life.
Caution: Impella ECP 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 U.S. 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.
The Impella 2.5, Impella CP, Impella CP with SmartAssist®, Impella 5.0®, Impella LD®, and Impella 5.5® with SmartAssist® are U.S. 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.
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/20210818005373/en/
Link:
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
Bridgepoint to Partner With ht.digital, the Leading Digital Asset Transparency Layer25.11.2025 09:00:00 CET | Press release
Bridgepoint to become majority shareholder in ht.digital, a London headquartered specialist provider of audit, accounting, assurance, operational and technology solutions to the digital asset ecosystem ht.digital has delivered organic revenue growth of c.100% over the last two years, scaling rapidly in a fast-growing market The partnership will accelerate ht.digital’s international expansion and continued investment in technology, talent and brand Bridgepoint, one of the world’s leading mid-market investors, today announced that it has agreed to acquire a majority stake in ht.digital, a leading, London-headquartered provider of digital asset assurance and technology solutions. The investment will be made by Bridgepoint Development Capital V – Bridgepoint’s lower middle-market fund focused on supporting fast-growing businesses across Europe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251125907148/en/ Digital assets – incl
Thredd Signs Landmark Agreement to Enable Visa Cloud Connect Globally25.11.2025 09:00:00 CET | Press release
Agreement sets stage for strengthened global reach, scalability, and resilience for fintechs and banks worldwide Thredd, a leading next-generation global payments processor, today announced that it has signed an agreement to enable Visa Cloud Connect on a global scale. This milestone reflects Thredd’s continued investment in cloud-first infrastructure and reinforces its role as a global technology leader in payments processing. Visa Cloud Connect allows organisations to access VisaNet, Visa’s secure and powerful global payments network, through their own cloud-based infrastructure. Purpose-built for cloud-native clients, Visa Cloud Connect can help deliver increased flexibility, faster time to market, and seamless scalability across borders. Under the agreement, Thredd will connect across three global Visa Cloud Connect endpoints, committing to a full global rollout. Once live, this will eliminate the need for multiple regional integrations, helping our clients gain new geographies and
Allvue Expands European Footprint, Names KPMG Luxembourg as Core Implementation Partner25.11.2025 08:56:00 CET | Press release
The partnership offers managers seamless access to specialized local expertise and regulatory knowledge, ensuring accelerated confidence in adopting world-class, API-first technology, including Allvue’s AI tool, Andi. Allvue Systems, LLC (“Allvue”), a leading software technology provider for the private capital markets, today announced an expansion of its current presence in EMEA, naming KPMG Luxembourg as its core implementation partner for all client deliverables for Europe. The strategic collaboration is designed to meet the growing demand from global asset managers leveraging Luxembourg as the premier European fund domicile. By aligning Allvue’s world-class, unified technology platform and solutions with KPMG’s renowned local expertise in private assets, deep regional relationships, and plurilingual delivery capabilities, the partnership offers clients a faster, more effective path to technology adoption. “Our mission is to make private markets more transparent, efficient, and conn
Datassential Expands Global Menu Intelligence with Debut of Global Launches25.11.2025 08:30:00 CET | Press release
Datassential, the leading global food and beverage intelligence platform, announced the debut of Global Launches, an expanded menu–tracking solution offering a unified view of new menu items and limited-time offers (LTOs) across major international markets. Global Launches now tracks menu innovation across hundreds of restaurant chains in the European, Latin American, and Asia-Pacific markets. Building on the robust menu tracking already available in the U.S. and Canada, this expansion gives foodservice businesses a comprehensive view of new menu items and LTOs around the globe, providing unmatched visibility into how trends and flavors appear across worldwide markets and evolve to fit local tastes. “Innovation doesn’t happen in one market at a time — it’s global, constant, and increasingly fast,” said Jim Emling, CEO of Datassential. “Global Launches now offers our customers a single, trusted source to see what’s launching across the world, how concepts are localized, and where the ne
Friendly Fraud Expected to Increase by 25% Between Thanksgiving and Cyber Monday, Warns ACI Worldwide25.11.2025 08:00:00 CET | Press release
ACI’s Payments Intelligence approach offers merchants complete journey protection—stopping friendly fraud and chargeback abuse in real timeACI expects industry leading fraud approval rate of 98% during holiday season - outperforming market averages 'Friendly fraud’ is expected to increase by 25% between Thanksgiving and Cyber Monday, according to an analysis of billions of transactions of global eCommerce businesses by ACI Worldwide (NASDAQ: ACIW), an original innovator in global payments technology. ‘Friendly fraud’ or ‘return fraud’ occurs when legitimate customers dispute transactions post-purchase. Often mistaken for true fraud, these disputes are a growing industry challenge and cost retailers $103 billion in 2024 alone, according to a recent industry report. The average transaction value for a ‘friendly fraud’ item during this year’s holiday season is expected to reach $291, $52 higher than during the same period last year, representing a 21% YoY increase. “These numbers are stag
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