MA-ABIOMED
Abiomed’s (NASDAQ: ABMD) newest right heart pump, the Impella RP with SmartAssist, has received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) as safe and effective to treat acute right heart failure for up to 14 days.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210629005367/en/
Impella RP with SmartAssist is the first single-access temporary percutaneous ventricular support device with dual-sensor technology. Impella RP with SmartAssist is an innovative advancement of Impella RP, which was granted a PMA by the FDA in 2017 and has treated thousands of patients globally with right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. Additionally in June 2020, the FDA issued an emergency use authorization (EUA) for Impella RP as a treatment for patients suffering from COVID-19-related right heart failure or decompensation, including pulmonary embolism (PE).
“Impella RP with SmartAssist further improves an incredibly valuable tool to treat right heart dysfunction,” said Robert Salazar, MD, interventional cardiologist, Memorial Hermann Health System Northeast Hospital and Kingwood Medical Center. “The addition of SmartAssist technology to Impella RP is an important advancement to help physicians achieve even better patient outcomes with an improved design and intuitive metrics.”
Impella RP with SmartAssist is:
- The first dual-sensor technology heart pump, providing real-time guidance and trends to help with pump management and weaning
- Designed for a simplified setup and insertion
- Enhanced with Impella Connect to enable remote monitoring from any internet-connected device through a secure, HIPAA-compliant website
SmartAssist technology is also available on Impella CP and Impella 5.5 for management of left heart failure and early identification of right heart failure.
Early identification and treatment of patients requiring right heart support is critical because, as demonstrated in Lala et al. , 37% of acute myocardial infarction cardiogenic shock (AMICS) patients exhibit right heart dysfunction, which results in a significantly increased risk of mortality. When right heart failure is present, the use of Impella RP within 48 hours of cardiogenic shock onset leads to 73% survival, compared to 14% survival when implanted after 48 hours, according to a FDA PMA post-approval study presented at TCT Connect 2020.
“Early detection of right heart failure and early action is key to improving patient survival rates,” said Nishant Patel, MD, cardiothoracic surgeon at Palm Beach Gardens Medical Center. “Data demonstrates that Impella RP dramatically improves survival rates for critically ill patients in need of right heart hemodynamic support. I look forward to improving outcomes further with this new generation of Impella RP.”
One patient who benefited from treatment with the first generation of Impella RP is Nancy Wilkins, an active 69-year-old Cincinnati native. In December 2016, Nancy had gone to a routine dentist appointment when she suddenly blacked out at the checkout desk. At the hospital, the medical team discovered she was experiencing a heart attack and rushed her into surgery. When complications arose during surgery, cardiologists recognized Nancy was going into right heart failure and quickly implanted Impella RP to allow her heart to rest and recover. Click here to learn more about Nancy’s story.
The FDA indication for use of Impella RP with SmartAssist is as follows:
The Impella RP with SmartAssist System is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m2 , who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.
Impella RP with SmartAssist will be introduced in the United States through a controlled rollout at hospitals that follow cardiogenic shock best practice protocols .
ABOUT IMPELLA HEART PUMPS
The Impella RP® and the Impella RP® with SmartAssist® System are U.S. FDA approved to provide temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m², who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.
The Impella RP is also authorized for emergency use by healthcare providers (HCPs) in the hospital setting for providing temporary right ventricular support for up to 14 days in critical care patients with a body surface area ≥1.5 m², for the treatment of acute right heart failure or decompensation caused by complications related to coronavirus disease 2019 (COVID‐19), including pulmonary embolism (PE). The Impella RP has not been cleared or approved for the treatment of acute right heart failure or decompensation caused by complications related to COVID-19. The Impella RP has been authorized for the above emergency use by FDA under an EUA and has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
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/20210629005367/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
Zayed Sustainability Prize Honours Global Pioneers Advancing Progress14.1.2026 02:35:00 CET | Press release
US$5.9M awarded to 11 organisations and high schools from the UAE, Brazil, Canada, Nepal, Switzerland, Uganda and across six sustainability categories From AI-enabled diagnostics to Cooling-as-a-Service, this year’s winners deliver locally adapted innovations that empower millions In 18 years, the Prize has scaled solutions reaching more than 411 million people globally The Zayed Sustainability Prize, the UAE’s pioneering award for innovative solutions to global challenges, today announced the cohort of 2026 winners, celebrating 18 years of empowering communities and driving inclusive, sustainable progress around the world. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260113958706/en/ The 2026 winners of the Zayed Sustainability Prize were recognised by the President of the UAE in Abu Dhabi on 13 January 2026 (Photo: AETOSWire) In a ceremony held during Abu Dhabi Sustainability Week (ADSW) and attended by Heads of State, M
Alta Semper Secures USD 57.5 Million from EIB Group and IFC for Growth Fund II to Expand Healthcare Access Across Africa13.1.2026 19:30:00 CET | Press release
Alta Semper Capital LLP (“Alta Semper”), a London-based private equity firm focused on healthcare and consumer investments in high-growth markets, today announced that it has secured USD 57.5 million in commitments to Alta Semper Growth Fund II. These commitments come from a consortium of investors including the European Investment Bank (EIB) Group and the International Finance Corporation (IFC). This landmark partnership was signified earlier today with a momentous signing ceremony held at a Government Ministry in Cairo. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260113837616/en/ Andrew McDowell (EIB), Cheick Oumar Sylla (IFC), Gelsomina Vigliotti (EIB), Rania Al-Mashat (Minister of Planning, Economic Development and International Cooperation of Egypt), Bassel Rahmy (MSMEDA), Afsane Jetha (CEO, Alta Semper) and Mark Bryson-Richardson MBE (British Ambassador to Egypt) at the signing ceremony in Cairo. (Photo: AETOSWire)
500 Global and Creators HQ Support Creators and Founders Building Startups Collectively Valued at US$130M+13.1.2026 17:00:00 CET | Press release
500 Global, one of the world’s most active Silicon Valley-based venture capital firms1, and Creators HQ, the first content creator hub in the UAE and the Middle East enabling the creator ecosystem globally, announced the Creators Ventures Accelerator program is building and supporting creator-led startups collectively valued at over US$130 million.2 The Creators Ventures Accelerator received over 1,100 applications from content creators and technology startup founders across more than 70 countries. Following a competitive selection process, 21 creators and founders were chosen for the program. This cohort serves a community of 20M+ followers, subscribers, and users across platforms. “Creators represent a growing class of bona fide entrepreneurs, with 50 million creators globally, projected to grow at 10-20% annually over the next 5 years. The first iteration of this industry was built on visibility and virality to monetize. With consumers getting savvier and more discerning, we believe
Nexo Becomes First-Ever Title Partner of the U.S. ATP 500 Dallas Open in Multi-Year Deal13.1.2026 16:30:00 CET | Press release
The agreement builds on Nexo’s long-term approach to partnerships with established global sports institutions. Nexo, the digital assets wealth platform, has been named the U.S. ATP 500 Dallas Open’s first-ever Title Partner under a multi-year agreement beginning in 2026, as the company advances its long-term brand strategy through leading global sports properties. The partnership was unveiled in Dallas alongside the debut of the Nexo Dallas Open brand and the resurfacing of two public tennis courts in North Texas. As one of only two ATP 500 tournaments in the U.S. and the country’s sole indoor ATP Tour championship, the Dallas Open places Nexo among a limited group of ATP 500 title partners. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260113901822/en/ The Nexo Dallas Open “This partnership with Nexo represents a transformative milestone for the Dallas Open,” said Tournament Director Peter Lebedevs. “Securing a title spons
Blue Matter Establishes New Capabilities in Biopharma Research & Development Led by Partner, Tara Austraat-Churik13.1.2026 15:01:00 CET | Press release
Blue Matter is pleased to announce that it has established a practice area dedicated to serving clients in biopharmaceutical Research & Development (R&D). The practice is led by Tara Austraat-Churik, a Partner who joined the firm in September 2025. Tara Austraat-Churik has been serving life science clients for more than 20 years. Her areas of expertise include strategy development and implementation, operating model and organizational design, and process optimization in R&D and Medical Affairs. Prior to joining Blue Matter, she served as Managing Director in R&D, Health, Science, and Wellness at EY. She has a robust background in consulting, which also includes roles at Booz Allen Hamilton, Navitas, WPP, and IBM. She holds a BA and MA from the University of Notre Dame and an MSc in Translational Medicine from the University of Edinburgh. The R&D practice, according to Austraat-Churik, exists to help biopharma companies simplify and accelerate the pathway to market. She adds, “R&D organ
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