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
Global EV Alliance Releases EV Driver Survey Results: Myths Are Slowing EV Market17.11.2025 19:19:00 CET | Press release
In a groundbreaking survey of more than 26,000 EV drivers across 30 countries, an overwhelming 77% say persistent myths about electric cars are the single biggest obstacle to EV adoption in their nations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251118388193/en/ There are still significant differences in the EV market across countries, and not everyone has a wide range of car brands to choose from. Photo: Markus Rotevatn/Norwegian EV Association. 83% say they believe policy measures are needed to increase EV sales in their country. “Misinformation about EVs is a serious challenge. It can make policymakers less confident that electric vehicles are a viable solution to climate change and local air pollution,” says Joel Levin, chair of GEVA and Director of Plug in America. One common myth in many countries is that electric cars are a fire hazard. 88% of the EV drivers in the survey say they aren’t worried about their EV b
Dilawer Farazi Returns to Loomis Sayles as Co-Head and Portfolio Manager on the Emerging Markets Debt Team17.11.2025 16:59:00 CET | Press release
Loomis, Sayles & Company is pleased to announce that Dilawer Farazi, ACA, has rejoined the firm as Co-Head and Portfolio Manager of the Emerging Markets Debt (EMD) Team. Dilawer becomes the firm’s first London-based portfolio manager. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251117681347/en/ Dilawer Farazi, ACA, has rejoined Loomis Sayles as Co-Head and Portfolio Manager of the Emerging Markets Debt Team Dilawer brings over two decades of experience in emerging markets credit, having previously served as a Senior Credit Research Analyst at Loomis Sayles from 2018 to 2020. He rejoins the firm from Royal London Asset Management (RLAM), where he led the Emerging Markets Credit team and managed approximately USD $1 billion in assets across EM credit. At RLAM, he launched the firm’s first dedicated emerging markets funds, including an emerging markets corporate bond fund and an emerging markets short duration credit fund. I
Duravant Announces Retirement of CEO Mike Kachmer, Names Jill Evanko Successor17.11.2025 16:13:00 CET | Press release
Mike Kachmer to retire following a distinguished 43-year career, including nearly 12 years as Chairman & CEO of Duravant Jill Evanko to succeed Mr. Kachmer as Duravant’s Chief Executive Officer Duravant LLC (“Duravant”), a global leader in advanced automation solutions, announced today that Mike Kachmer will retire from his role as Chief Executive Officer after a highly successful tenure with the company. Duravant’s Board of Directors has named Jill Evanko as CEO, joining the company on January 5, 2026. To ensure a seamless transition, Mr. Kachmer will continue to serve as Chairman of Duravant. Mr. Kachmer will also continue to serve on the Board of Directors for Northwestern Memorial Healthcare and The London Clinic. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251117036720/en/ Mike Kachmer “It has been a true honor and a humbling experience to lead this incredible company,” said Mr. Kachmer. “I am profoundly grateful to
Wolters Kluwer Enablon Control of Work Solution Now Available as Private Offer in AWS Marketplace17.11.2025 15:00:00 CET | Press release
Wolters Kluwer today announced that its Enablon Control of Work solution is now available in AWS Marketplace as a private offer. This purchasing model empowers customers to negotiate and receive tailored pricing, terms, and licensing agreements, while streamlining procurement and leveraging existing Amazon Web Services (AWS) billing workflows to accelerate deployment and optimize cloud budgets. Wolters Kluwer’s Enablon Control of Work solution consolidates permit-to-work, isolation management and risk assessments into an integrated system. Trusted by frontline workers and contractors in high-risk environments including oil & gas, pharmaceuticals, data center and manufacturing industries, the software helps streamline operations, minimize unplanned downtime and prevent serious injuries and fatalities. Richard Pulliam, SVP & General Manager of EHS & ESG for Wolters Kluwer, said: “Making Enablon's Control of Work solution available in AWS Marketplace is another step in our mission to help
Morningstar's 2026 Outlook Report Delivers Global and Regional Insights for Durable Portfolios17.11.2025 15:00:00 CET | Press release
Morningstar, Inc. (Nasdaq: MORN), a leading provider of independent investment insights, today published its 2026 Outlook, offering an overview of key challenges and opportunities for the year ahead. In a market defined by uncertainty, this year’s report emphasizes the value of preparation over prediction, equipping investors with strategies to focus on fundamentals and help build resilient portfolios that withstand both booms and busts. Drawing on insights from Equity, Manager, and Behavioral research analysts worldwide, this Outlook distills Morningstar’s thinking on how to navigate opportunity and risk across every major asset class in 2026. "Markets are unpredictable, and the geopolitical and tariff uncertainty of 2025 showed just how quickly forecasts can shift. That’s why Morningstar is redefining the Outlook, focusing on durable portfolios rather than short-term predictions,” said Dan Kemp, chief research and investment officer. “No matter what market conditions the year ahead m
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