FDA Grants Highest Level of Approval to the Next Generation of Impella RP to Treat Right Heart Failure
29.6.2021 15:03:00 EEST | Business Wire | Press release
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 Receives FDA Pre-Market Approval (Photo: Business Wire)
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.
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/20210629005367/en/
Contact information
Sarah Lima
Communications Manager
978-882-8211
slima@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
Klarna Launches on Google Pay in the UK16.2.2026 10:00:00 EET | Press release
Klarna, the global digital bank and flexible payments provider, is now available on Google Pay in the UK. Google Pay users in the U.K. can choose Klarna’s interest-free payment options at checkout. Raji Behal, Head of Western and Southern Europe, UK & Ireland at Klarna, said, “We’re really excited to bring Klarna’s fair, flexible and interest-free payment options to Google Pay users. This is a big moment for us and a major step towards our goal of being available at every checkout, everywhere. Together with Google, we’re making it easier than ever for millions of shoppers to choose Klarna and pay in a smarter, more transparent way — all from their phone.” Lisa Yokoyama, Director of Product Management at Google Paysaid: "Expanding our collaboration with Klarna to the U.K. underscores our goal to empower more people with the flexibility to pay how they choose. With people shopping on Google over a billion times a day, this broader footprint provides even more checkout options to help bus
Italy Sees Economic Boost From the Opening Weekend of the Olympic Winter Games Milano Cortina 202616.2.2026 10:00:00 EET | Press release
Visa, the Official Payment Technology Partner of the Olympic and Paralympic Winter Games, today released new data revealing consumer spending patterns in the Winter Games host locations1 during the opening weekend of the Olympic Winter Games Milano Cortina 2026. VisaNet data analysed by Visa Consulting & Analytics (VCA) shows the positive impact that Milano Cortina 2026 is having on commerce: Overseas Visa cardholders visits rose by more than 60%, with the largest share of visitors coming from the U.S. (+160% year-on-year), followed by China, Brazil, Canada and Japan. In Europe, Visa cardholders from Germany represent the largest share of visitors (31% year-on-year increase), followed by Switzerland, France and the UK. International Visa cardholders spent more than in the previous year, with the U.S. leading the year-on-year growth with a 125% increase in their spending, followed by Canada and Switzerland. Visitors from Germany, China and the U.S. ranked as the top spenders, with an av
New ECCO data show subcutaneous (SC) infliximab (Remsima ™ SC) effectively recaptures and maintains disease control after drug holiday16.2.2026 09:00:00 EET | Press release
Celltrion, Inc. today announced new data from a post-hoc analysis of the pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC), showing that subcutaneous (SC) infliximab restored and maintained response in most Crohn’s disease (CD) and ulcerative colitis (UC) patients with sustained efficacy, safety, and persistence through to Week 102.1 The data will be presented as a poster presentation at the 21st Congress of the European Crohn’s and Colitis Organisation (ECCO), to be held from February 18-21 in Stockholm, Sweden. “As immunogenicity is the most significant concern when restarting treatment with infliximab after an interruption, these results suggest that treatment persistence was maintained even in patients with immunogenicity,” said Dr. Marla Dubinsky, Professor of Pediatrics and Director of the IBD Center at the Icahn School of Medicine at Mount Sinai. “It's reassuring to see that not only can we effectively recapture disease control with a convenient subcutaneous option, but that t
Galderma Announces Appointment of New Chief Financial Officer16.2.2026 08:00:00 EET | Press release
Galderma Group AG (SIX:GALD), the pure-play dermatology category leader, today announced the appointment of Luigi La Corte as Chief Financial Officer (CFO), effective May 1, 2026. Luigi La Corte will join Galderma on April 1 to begin a smooth and orderly transition with Thomas Dittrich, who has served as CFO of Galderma since October 2019. As previously announced, Thomas will remain with the company through Q2 2026 to ensure a seamless transition before pursuing another senior executive opportunity outside the organization. “Luigi La Corte is an accomplished financial leader with deep experience across global healthcare and consumer organizations. I am delighted to welcome him to the Executive Committee and look forward to working with him closely as we continue to execute our Integrated Dermatology Strategy and extend our category leadership in dermatology. I would also like to thank Thomas for his commitment to ensuring a seamless transition and his many contributions to Galderma dur
REJO brings CUBE modular device to Japan in its global premiere16.2.2026 04:00:00 EET | Press release
REJO, a pioneering global provider of heat-not-burn (HNB) solutions, today announced the global debut of REJO CUBE, its latest modular HNB device, in Japan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260215596376/en/ REJO CUBE DEVICE-Product Infographic Breaking away from conventional HNB design norms, REJO CUBE introduces a bold new device option featuring a trendy design and dual-mode inhalation experience, launching on Japan’s major e-commerce retail channels from February 16. This launch marks the brand’s latest move following REJO Mate Air’s introduction in Japan in July 2025, when the device’s compact design, smooth mouthfeel, and Puff Twice feature won widespread acclaim among local adult users. REJO CUBE speak for REJO’s ongoing commitment to placing user experience at the core of its research and development effort, bringing kit flexibility with modular design, deep user engagement with interactive features, and
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