Two Large Studies Demonstrate Complete Revascularization with Impella Heart Pumps Improves Ejection Fraction and Long-Term Patient Outcomes
The final results of the PROTECT III and Restore EF prospective studies demonstrate improved outcomes for high-risk PCI patients with the use of Impella heart pumps. The study results were reviewed this morning at Transcatheter Cardiovascular Therapeutics (TCT) 2021, the annual scientific symposium of the Cardiovascular Research Foundation, by Gregg Stone, MD, director of academic affairs for the Mount Sinai Health System in New York City. The presentation is available to watch on-demand at www.heartrecovery.com/tct-2021.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211104005652/en/
Gregg Stone, MD, reviews the final results of the PROTECT III study in the Clinical Science Theater at TCT 2021 (Photo: Business Wire)
“The contemporary data from these two prospective studies provide evidence that the adoption of Impella best practices is improving safety and reducing MACCE in the high-risk PCI patient population,” said Dr. Stone. “These best practices are being examined in a broader patient population as part of the ongoing PROTECT IV Randomized Controlled Trial of Impella in high-risk PCI, which hypothesizes that by providing hemodynamic stability during high-risk PCI, Impella will facilitate more optimal stent implantation and complete revascularization, and that will translate into improved early and late patient outcomes.”
PROTECT III Final Results
The PROTECT III prospective study demonstrates improvement in 90-day clinical outcomes, completeness of revascularization, and safety, when compared to the PROTECT II Randomized Controlled Trial (RCT). The PROTECT II RCT found, when compared to intra-aortic balloon pump (IABP), Impella use led to a 29% relative risk reduction in MACCE at 90 days.
Study authors analyzed patients in PROTECT III who would have qualified for PROTECT II, known as “PII-like” patients, and compared them to PROTECT II patients. PROTECT III patients had improved 90-day MACCE rates, compared to PROTECT II patients (15.1% vs. 21.9%, p=0.037). This is a relative risk reduction of 31%. (see figure 1)
The study authors also note that PROTECT III patients, when compared to patients in PROTECT II:
- Were more complex, with more severe calcification, more rotational atherectomy and more vessels treated.
- Had more complete revascularization, with 78% less hypotension during support (2.2% vs. 10.2%, p=0.0004).
- Had improved in-hospital safety, with significantly fewer bleeding complications requiring transfusion (1.2% vs. 9.4%, p<0.001).
Restore EF Final Results
The Restore EF prospective study demonstrates the use of contemporary best practices with Impella in high-risk PCI significantly improves left ventricular ejection fraction (LVEF), heart failure symptoms, and anginal symptoms at 90-day follow-up in a wide variety of hospital settings including rural, urban, community and academic centers.
The study of 251 patients at 26 hospitals showed:
- Significant improvement in LVEF from baseline to 90-day follow-up (35% to 45% p<0.0001). LVEF improvement at 90 days is the study’s primary endpoint. Restore EF is the latest study in a growing body of evidence demonstrating LVEF improvement with Impella-supported high-risk PCI. (see figure 2)
- Significant reduction of heart failure symptoms with 76% reduction in New York Heart Association (NYHA) classification III/IV at follow-up (62% to 15% p<0.001). (see figure 3)
- Significant reduction of anginal symptoms with 97% reduction in Canadian Cardiovascular Society (CCS) classification III/IV at follow-up (72% to 2% p<0.0001). (see figure 3)
Advancement in Technology and Best Practices
Since PROTECT II, Impella-supported high-risk PCI has evolved to include the more powerful Impella CP with SmartAssist heart pump, which was used in about two-thirds of the patients in the Restore EF and PROTECT III studies.
“Advancement in technology, along with best practice learnings and operator experience has led to improvements in patient outcomes in contemporary practice,” said Jeff Moses, MD, the lead investigator of the PROTECT III study, director of interventional cardiovascular therapeutics and professor of medicine at Columbia University Medical Center in New York City, and director of advanced cardiac interventions at St. Francis Hospital and Heart Center in Roslyn, NY. “These two studies expand upon prior research and demonstrate a clinical benefit in today’s broader patient population.”
The PROTECT series of studies and the Restore EF study are sponsored by Abiomed (NASDAQ: ABMD) as part of its commitment to improving clinical outcomes.
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/20211104005652/en/
Contact information
For further information:
Media Contact:
Tom Langford
Director of Communications
+1 (978) 882-8408
tlangford@abiomed.com
Investor:
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
SCENTMATIC's AI "KAORIUM" Debuts at THAMEEN Fragrance Launch in London's Selfridges4.7.2025 12:13:00 EEST | Press release
SCENTMATIC Inc., a leader in scent digitalization, introduced its AI-powered scent-to-language system, KAORIUM, at the THAMEEN Fragrance new product launch event. This pivotal event took place from June 5 to 11, 2025, at Selfridges department store in London, UK. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250703662207/en/ State of exhibition Global Expansion: KAORIUM Establishes UK Presence Europe leads the global fragrance market, with the UK projected to reach US$2.82 billion by 2033. Recognizing this, SCENTMATIC is rapidly expanding its international footprint. In May 2024, SCENTMATIC established its overseas subsidiary, KAORIUM, in London, appointing industry expert Ben Yanoushek as CEO. Official UK operations commenced on February 1, 2025, with the launch of its dedicated website: www.kaorium.com. KAORIUM Trialed at "Florentine Diamond" Launch Event The "Florentine Diamond" launch event for luxury brand THAMEEN Frag
Global Tourism Surging Ahead of Economic Growth, With Visits to Hit 30 Billion by 20344.7.2025 02:00:00 EEST | Press release
The World Economic Forum has today published a new report forecasting that the travel and tourism industry is projected to serve 30 billion tourist trips by 2034. Travel and Tourism at a Turning Point: Principles for Transformative Growth, produced in collaboration with Kearney and the Ministry of Tourism Saudi Arabia, reveals a projected $16 trillion contribution to global GDP by the same year—representing more than 11% of the total world economy, according to World Travel & Tourism Council estimates. The report also found that the sector is expanding 1.5 times faster than the global economy, generating significant commercial opportunities as long as the mounting challenges of climate change, labour shortages and infrastructure gaps are addressed. Inbound and outbound trips increasing fast Asia is on track to become the world’s fastest-growing tourism economy, with the direct travel and tourism GDP contribution expected to exceed 7% across the region by 2034. Notably, India and China
The 2025-2026 World Branding Awards Animalis Edition Honouring Leading Pet and Animal Brands Globally3.7.2025 22:00:00 EEST | Press release
The 2025-2026 World Branding Awards Animalis Edition marked its fifth instalment, bringing together leading pet and animal brands from all around the world. These brands were celebrated for their outstanding achievements, earning recognition as National, Regional, and Global Winners. The awards ceremony, held at Vienna's prestigious Hofburg Palace, welcomed winners across diverse categories, including pet food, retail, wellness, pet exhibitions, and aquatic products. Mounia Berrada-Gouzi expertly hosted the evening, which culminated in a grand celebration of brand excellence. “The Animalis Edition of the World Branding Awards recognises brands that have achieved the highest distinction—genuine recognition in the hearts and minds of consumers. Tonight, we honour those whose names resonate globally, whose values inspire loyalty, and whose presence defines excellence in the pet and animal industry,” said Richard Rowles, Chairman of the World Branding Forum. Out of over 950 brands nominate
Venture Global Announces 20-Year Sales and Purchase Agreement with PETRONAS3.7.2025 15:59:00 EEST | Press release
Today, Venture Global, Inc. (NYSE: VG) announced the execution of a new 20-year Sales and Purchase Agreement (SPA) with PETRONAS LNG Ltd. (PLL), a subsidiary of the Malaysian state-owned oil and gas company, PETRONAS. Under the terms of the SPA, PETRONAS will purchase 1 million tonnes per annum (MTPA) of liquefied natural gas (LNG) from Venture Global’s third facility, CP2 LNG, for 20 years. This builds upon Venture Global’s existing agreement with PETRONAS for 1 MTPA of LNG supply from Plaquemines LNG. PETRONAS, a world-class partner in the LNG industry, joins other CP2 LNG customers in Europe, Asia and the rest of the world in a strategically important project to global energy supply and security. To date, approximately 10.75 MTPA of the 14.4 MTPA nameplate capacity for CP2 Phase One has been sold. About Venture Global Venture Global is a long-term, low-cost provider of U.S. LNG sourced from resource rich North American natural gas basins. Venture Global’s business includes assets ac
Frost & Sullivan Recognizes Novotech as 2025 Global Biotech CRO Company of the Year3.7.2025 15:05:00 EEST | Press release
In recognition of its innovation, client-focused delivery, and global impact, Novotech has been awarded the 2025 Global Biotechnology Contract Research Organization (CRO) Company of the Year by Frost & Sullivan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250703950144/en/ Novotech Wins Global CRO Award Novotech is a globally recognized full-service clinical CRO and scientific advisory firm, trusted by biotech and small- to mid-sized pharmaceutical companies to advance their drug development programs at every phase. With a global footprint spanning Asia-Pacific, North America, and Europe, Novotech supports over 5,000 clinical trial sites and a distributed team of experts delivering seamless, end-to-end solutions across geographies. “Novotech is redefining biotech-focused clinical research through AI-driven innovation, global expansion, and a client-embedded partnership model. With a clear vision to be the CRO of choice for
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