TCT 2021 to Highlight Improved Patient Outcomes with Impella’s Small, Smart and Connected Technology
1.11.2021 14:58:00 EET | Business Wire | Press release
The robust, high-quality data and clinical studies supporting the use of Abiomed's (NASDAQ:ABMD) Impella heart pumps in high-risk PCI, cardiogenic shock and right heart failure patients will be showcased at Transcatheter Cardiovascular Therapeutics (TCT) 2021, the annual scientific symposium of the Cardiovascular Research Foundation. The conference will meet virtually and in-person in Orlando, Florida, on November 4 – 6.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211101005297/en/
Impella CP with SmartAssist, shown placed in the heart’s left ventricle. (Photo: Business Wire)
Impella heart pumps are the world’s smallest heart pumps. They unload the heart while providing coronary and end organ perfusion. Impella SmartAssist technology enables improved patient outcomes via real-time intelligence. Abiomed augments limited hospital resources by providing 24x7 support on-site, on-call and online.
Throughout TCT, and at a pre-conference workshop on November 3, leading physician-researchers will present data demonstrating:
- Complete revascularization with Impella improves ejection fraction and long-term patient outcomes.
- Cardiogenic shock best practices, including early unloading with Impella pre-PCI and timely escalation to Impella RP and Impella 5.5 with SmartAssist, are associated with improved survival and native heart recovery.
During TCT 2021, physicians will detail final results from two large studies of Impella -- the PROTECT III post approval study and the RESTORE EF study. Interim results from both studies were presented at TCT 2020 and demonstrated the benefits of using contemporary practices to achieve complete revascularization with Impella.
The high-quality clinical evidence being generated from the PROTECT series of studies includes the PROTECT II randomized controlled trial (RCT) and the ongoing PROTECT IV RCT of Impella use in high-risk PCI patients. Based on PROTECT II RCT data, and data from additional robust prospective clinical studies, the United States Food and Drug Administration (FDA) granted Impella premarket approvals (PMA) as safe and effective for high-risk PCI, cardiogenic shock and right heart failure.
TCT presenters will also review the real-world evidence (RWE) and best practices gathered since Impella’s FDA approvals. This evidence will inform the RECOVER IV RCT of Impella use in cardiogenic shock patients. The RWE includes prospective data from the National Cardiogenic Shock Initiative (NCSI) Study, J-PVAD Study and INOVA Study. These datasets demonstrate cardiogenic shock best practices, including early use of Impella, are associated with improved survival rates of 71%, 77% and 82% (respectively), compared to the historical cardiogenic shock survival rate of about 50%.
In-person attendees of TCT 2021 are invited to visit Abiomed at the TCT Industry Hub, which will be open from 8:00 am – 5:30 pm EDT. At the Hub, attendees will be able to participate in hands-on Impella demonstrations, view the newest technologies, talk with members of the Abiomed product development team, and learn the latest information about Abiomed’s ongoing and planned randomized controlled trials.
Virtual attendees of TCT 2021 are invited to participate in three ways:
- Visit www.HeartRecovery.com 24x7 to experience Abiomed’s virtual cath lab and view live and on-demand TCT-related video content.
- Follow the @HeartRecovery and @ProtectedPCI Twitter handles for the latest TCT news and events.
- Tune in for the live TCT recap program, livestreamed on www.HeartRecovery.com at 6:00 pm EDT on Thursday, November 4, and Friday, November 5. Chuck Simonton, MD, and Seth Bilazarian, MD, from the Abiomed medical office will present the top TCT news of the day. After the live broadcast, the program will be available for on-demand viewing.
In-person and virtual participants of TCT are invited to attend a breakfast symposium on Thursday, November 4. The principal investigators of the PROTECT IV RCT, the RECOVER IV RCT and the STEMI Door-to-Unloading RCT will update the physician community on the progress of those trials. The symposium will also review the clinical experience with the new 9 French Impella ECP heart pump. The schedule of presentations and instructions for in-person and virtual viewing are below:
Clinical Science to Landmark Trials of Left Ventricular Unloading in High-Risk PCI and Cardiogenic Shock
Date: Thursday, November 4, 2021
Time: 6:30 – 7:30 am EDT
In-Person Location: Orange County Convention Center, Clinical Science Theater, Level 1, Halls A & B
Virtual Location: Watch via the official TCT 2021 conference livestream
Presenters:
- PROTECT Series Leading to PROTECT IV, Gregg Stone, MD, Mount Sinai Health System, New York City
- Real World Evidence Leading to RECOVER IV, William O’Neill, MD, Henry Ford Hospital, Detroit
- Door to Unload: Implications for STEMI, High-Risk PCI and Cardiogenic Shock, Navin Kapur, MD, Tufts Medical Center, Boston
- Breaking the Small-Bore Barrier: Impella ECP 9 Fr Heart Pump Clinical Experience, Amir Kaki, MD, Ascension St. John Hospital, Detroit
In conjunction with TCT, Abiomed is also hosting a pre-meeting workshop on November 3 for members of CAMP PCI. CAMP PCI (Coronary Artery & Myocardial Protected PCI) is the leading online and in-person physician education platform dedicated to improving patient outcomes and quality of life with supported high-risk PCI by utilizing best practices, techniques and technologies to enable safer, more effective and complete revascularization.
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.
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/20211101005297/en/
Contact information
Media Contact:
Tom Langford
Director of Communications
+1 (978) 882-8408
tlangford@abiomed.com
Investor Contact:
Todd Trapp
Vice President and Chief Financial Officer
+1 (978) 646-1680
ttrapp@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
M1X Global Announces Public Launch and Oversubscribed $3 Million Angel Round to Scale On-Chain Sovereign Finance26.3.2026 14:13:00 EET | Press release
M1X Global, a sovereign financial infrastructure and technology company, today announced its public launch alongside the close of an oversubscribed $3 million angel round. The funding, spanning strategic investments and grants, will support platform development and accelerate regulated institutional adoption of USDM1, the first USD-denominated, treasury collateralized sovereign debt instrument issued natively by a sovereign on public blockchain infrastructure. The $3 million in funding drew participation from leading figures across global capital markets and digital asset infrastructure, including Balaji Srinivasan, former CTO of Coinbase; Tama Churchouse, CEO of Cumberland Labs; Richard Gorelick, former Head of Market Structure at DRW; and Dan Robichaud, former CIO at Intel. Institutional participation from FJ Labs and grant funding from Stellar Development Foundation reflect strong alignment between private capital and mission-driven partners advancing blockchain-based market develop
500 Global Taps Former IFC CIO As Firm Expands Global Investment Platform26.3.2026 14:00:00 EET | Press release
500 Global today announced the appointment of Atul Mehta to its Board of Directors, marking an important step in the firm’s continued evolution as a global venture platform and institutional asset manager. Mehta brings more than three decades of global investment and institutional leadership experience at a time when 500 Global has observed governments, multilateral institutions, and long-term capital providers rethinking how technology-led growth is financed and scaled. He has held senior roles across private capital and development finance, including at the International Finance Corporation (IFC), where he managed multi-billion-dollar portfolios spanning technology, venture funds, infrastructure, agribusiness, healthcare, education, and financial services across emerging markets. Over his career, he has helped design and govern investment platforms—including blended finance structures and cross-border funds—that translate national development priorities into market-oriented investmen
AI Ambitions at Risk as Only 14% of Enterprises Fully Realize Cloud Value, NTT DATA Study Finds26.3.2026 14:00:00 EET | Press release
NTT DATA, a global leader in AI, digital business and technology services, today released its new report, Cloud-led innovation in the era of AI: The new rules for driving value with cloud, revealing that just 14% of organizations have reached the highest level of cloud maturity despite nearly two decades of cloud adoption. Based on a global survey of more than 2,300 senior decision-makers across 33 countries, the findings highlight a paradox as cloud takes on a new and critical role as the execution layer of the AI operating model. While 99% of organizations say AI is increasing demand for cloud investment, 88% say current cloud investment levels are putting AI, cloud-native and modernization initiatives at risk. Additionally, while cloud is seen as essential for innovation, fewer than half of organizations are satisfied with its impact or with their modernization progress, signaling a disconnect between ambition and reality as expectations rise. Cloud leaders, or organizations that in
Visa Launches Enhanced Subscription Manager, Giving Consumers Greater Control Over Recurring Payments26.3.2026 13:00:00 EET | Press release
Visa (NYSE: V), a global leader in digital payments, today unveiled an Enhanced Subscription Manager solution, a new value‑added service within its Digital Issuer Solutions business. As the number of subscriptions worldwide is projected to reach 12 billion by 2030, consumers are seeking simple, transparent ways to track and manage recurring charges. In support of this, Visa is collaborating with Pinwheel, a leading provider of in‑app bill management capabilities. Enhanced Subscription Manager helps issuers respond to consumer demand by offering a consolidated, easy-to-integrate solution that elevates the user experience. Issuers can give cardholders greater subscription visibility, easy payment switching methods and cancellation capabilities, all without leaving their banking app. This helps reduce unwanted charges by giving consumers greater confidence and control over recurring subscription payments. Issuers can help strengthen engagement, improve retention, and reduce disputes and c
Smartstream Smart Agents Delivers 70% Reduction in Back-Office Investigation Time, Proving the Case for Autonomous Operations26.3.2026 11:30:00 EET | Press release
Smartstream, the trusted data solutions provider for leading global financial institutions and enterprises, today announces that Smart Agents - its agentic AI solution for bank back-office operations is delivering measurable, transformational impact, with pilot results showing a 70% reduction in investigation time per user, per break. As the industry accelerates toward a service as software (SaS) operating model, and allowing more work to get done from software solutions, Smartstream is embracing this approach with agentic AI. The results validate a fundamental shift in how financial institutions approach exception management. In one benchmark scenario, the manual processing of 500 exceptions, typically requiring 116 hours of team effort, was reduced to just a few hours under fully autonomous operations. This eliminates swivel-chair workflows and frees up teams to focus on risk oversight, decision making, and higher-value activities. Institutions continue to struggle with back-office w
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