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
Quaise Energy Raises $134 Million in Initial Close of Series B to Build World’s First Superhot Geothermal Power Plant7.7.2026 15:01:00 EEST | Press release
Quaise Energy, a leading developer of utility-scale superhot geothermal energy, today announced the first close of its Series B financing, raising $134 million with additional equity and debt capital expected to close imminently. The round was led by Prelude Ventures, with strategic investments from JERA and Idemitsu, two of Japan's largest energy companies. Nearly all existing investors, including Safar Partners, participated in the round. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707844187/en/ The proceeds from Series B will fund Project Obsidian, the world’s first commercial superhot geothermal power plant, and the continued development and commercialization of Quaise's millimeter wave drilling system towards depths in excess of 5 km. Project-level equity and debt financing is concurrently being raised as the company advances toward first revenues secured by yet-undisclosed commercial off-take partners. The Series
Biocytogen and Whitehawk Therapeutics Enter Global Collaboration for Bispecific Antibody ADC Development7.7.2026 15:00:00 EEST | Press release
Biocytogen (SSE: 688796; HKEX: 02315) and Whitehawk Therapeutics, Inc. (“Whitehawk,” Nasdaq: WHWK) today announced a global collaboration to develop bispecific antibody-drug conjugates (BsADC). Biocytogen will provide access to up to five bispecific antibodies using its proprietary RenLite® platform, and Whitehawk will evaluate these in combination with its ADC linker-payload platform technologies. Whitehawk then has the option to advance any resulting BsADC candidates as part of its pipeline. Based on a common light-chain design, RenLite® supports the discovery, screening, and optimization of fully human bispecific antibodies across diverse target combinations, while reducing the risk of light-chain mispairing and providing a robust molecular foundation for subsequent BsADC development. By bringing together the complementary capabilities of Biocytogen and Whitehawk, the collaboration aims to identify BsADC candidates with differentiated targeting profiles and therapeutic potential. “W
UMA Unveils Its Vision for the Next Generation of Humanoid Robots7.7.2026 15:00:00 EEST | Press release
At Machina Summit, UMA, a Physical AI company, unveiled the design of its first humanoid robot and introduced Real-Time Learning, a learning architecture that enables robots to acquire new skills through demonstration instead of manual programming. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707215927/en/ The announcement comes as aging populations, industrial reshoring, and the energy transition place increasing pressure on labor markets across advanced economies. According to Korn Ferry, the global economy could face a shortage of 85 million workers by 2030, representing as much as $8.5 trillion in unrealized economic output. Against this backdrop, UMA is developing a new generation of intelligent robots built to assist people by taking on physically demanding, repetitive, or hazardous work. "Demographic, industrial, and environmental challenges all point to the same reality: societies need greater productive capacit
Bregal Milestone III Closes at its Increased Hard Cap of €915 Million7.7.2026 14:00:00 EEST | Press release
Bregal Milestone (“Milestone” or the “Firm”), a leading European software private equity firm, today announced the final close of its third fund, Bregal Milestone III (“Fund III” or the “Fund”), at its increased hard cap of €915 million. The Fund was oversubscribed and marks a significant broadening of the Firm’s global investor base. Completed in eight months from first close and achieved against a challenging fundraising environment, the result reflects the strength of Milestone’s AI-centric approach and demonstrable track record. Jan Bruennler, Philippe Lautenberg and Cyrus Shey, Co-Founders and Managing Partners at Bregal Milestone, commented: “Bregal Milestone III reflects strong conviction in our approach to investing in mission-critical European software, AI and cybersecurity businesses and helping them scale. We are thankful for the support and confidence shown by our limited partners, both longstanding and new, and remain focused on executing the strategy that has defined Mile
HTEC and Embotech Partner to Scale Deployment of Autonomous Driving Solutions for Industrial Logistics7.7.2026 13:39:00 EEST | Press release
HTEC, a global technology and AI engineering company headquartered in Silicon Valley, and Embotech, a global leader in safety-certified Level 4 autonomous driving solutions for industrial logistics, today announced a strategic partnership to scale deployment of Embotech's autonomous driving solutions across vehicle platforms, customer programmes and industrial sites. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707870943/en/ HTEC, a global technology and AI engineering company headquartered in Silicon Valley, and Embotech, a global leader in safety-certified Level 4 autonomous driving solutions for industrial logistics, today announced a strategic partnership to scale deployment of Embotech's autonomous driving solutions across vehicle platforms, customer programmes and industrial sites. The partnership comes as Embotech’s proven autonomous driving solutions are being adopted across a growing number of vehicle platforms
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