MA-ABIOMED
29.6.2021 14:05:04 CEST | 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 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
Lyft App Launches in Europe30.9.2026 14:00:00 CEST | Press release
North American riders can use their Lyft app when traveling in Europe Key takeaways: North American Lyft riders can now use one app in the U.S., Canada, and Europe. No need to download anything new. New technology allows the Lyft app to integrate any third-party marketplace, laying the groundwork for future international growth. Lyft has transformed from an everyday rideshare company into a global, multi-mobility platform. Starting today, Lyft (NASDAQ: LYFT) riders can use their Lyft app in cities across Europe. Early access to the Lyft app rolls out in Barcelona and Hamburg first; throughout October, the Lyft app will become available for riders to use in some of Europe’s largest cities including London, Rome, Paris, Berlin, Athens, and Warsaw. By the end of October riders visiting Spain, Italy, Greece, Poland, England, Scotland, Ireland, Austria, France, and Germany will have one go-to app when they cross the Atlantic, building on the foundations from this past summer beta testing th
A Workplace Worth Toasting: Bacardi Continues its Rise on Forbes World’s Best Employers List30.9.2026 13:45:00 CEST | Press release
Bacardi Takes Top Spot Among Spirits Companies with Jump to #69 Bacardi Limited is proving that a workplace worth toasting keeps getting better. The family-owned business has once again been named to the Forbes World's Best Employers list, taking the top spot among spirits companies. Climbing 17 places since last year, in 2026 Bacardi comes in at #69 globally. The jump in ranking reflects a commitment to creating a workplace where employees feel valued, empowered, and inspired to grow while helping shape the future of the company. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260930327935/en/ Bacardi Limited Leads Spirits Companies Forbes World's Best Employers 2026 Ranking. “At Bacardi, great moments start with great people. That's why we listen carefully to what they're telling us, learn from that feedback, and keep evolving. We want people to feel clear on how they can grow, confident they can make their mark, and suppor
Forrester’s 2027 European Predictions: Despite A Strong Desire To Regain Its Digital Sovereignty, Europe Will Selectively Reset, Not Sever, Key Technology Relationships30.9.2026 13:33:00 CEST | Press release
New AI sovereignty and platform governance rules will signal strategic intent but deliver limited near-term impact According to Forrester’s (Nasdaq: FORR) 2027 European predictions, unveiled today at Forrester’s Technology & Innovation Forum EMEA, Europe will enter 2027 determined to recover its digital autonomy, but the gap between its ambition and control will widen. More than half of European companies embracing AI will reduce their dependence on US hyperscalers due to sovereignty concerns, moving their critical data and applications to European providers. A lack of end-to-end sovereign alternatives, however, will require consumers, companies, and policymakers to pursue selective digital autonomy, which consequently will reshape consumer behaviours, cloud choices, mobility, resilience, and trade strategy with China. Forrester’s Predictions reports offer forward-looking insights into trends to help executives and their teams anticipate change, reduce uncertainty, and make confident d
Vasion® Named a Leader in the 2026 IDC MarketScape for Worldwide Print Management Solutions as Enterprise Print Becomes AI Ready30.9.2026 13:30:00 CEST | Press release
Vasion, the intelligent print automation company, today announced it has been named a Leader in the IDC MarketScape for Worldwide Print Management Solutions 2026 Vendor Assessment (doc # US54124826, September 2026). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260930788016/en/ According to the IDC MarketScape, "Organizations in sectors such as education, healthcare, government, manufacturing, financial services, and retail should consider Vasion when seeking support for business process automation revolving around print, output, and agentic or rules-based workflows. Vasion customers may derive considerable value from the vendor's solutions in support of unifying their organizations' digital transformation efforts, particularly where a single portal with functionality extending beyond print management is sought, and especially where FedRAMP® High Authorization, a SOC 2 Type II report, or ISO 27001/42001 certification is req
Pantheon Expands Middle East Presence With New Abu Dhabi Office and Senior Regional Appointment30.9.2026 12:56:00 CEST | Press release
Abu Dhabi office, based in ADGM, continues Pantheon’s global expansion to serve growing client demand in key markets such as the Middle EastFiras Mallah joins as Managing Director and Head of Middle East to lead capital formation with sovereign wealth funds, family offices, and financial institutions across the region Pantheon, a leading global private markets firm with approximately $84bn in assets under management, today announced the expansion of its presence in the Middle East with the opening of its first office in ADGM, the international financial center based in Abu Dhabi, alongside the appointment of Firas Mallah as Managing Director and Head of Middle East. Demand for access to private equity, infrastructure, and private credit strategies continues to build among sophisticated investors across the Middle East, who recognize Pantheon for its 40-year track record of innovation and expertise across primaries, secondaries and co-investment opportunities. Secondaries – pioneered by
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