First Patient Enrolled in PROTECT IV Randomized Controlled Trial of Impella
15.4.2021 15:03:00 EEST | Business Wire | Press release
Abiomed (NASDAQ:ABMD) announced today that the first patient has been enrolled in PROTECT IV, a large, prospective, multi-center randomized controlled trial (RCT) that is designed to provide the level of clinical evidence needed to achieve a Class I guideline recommendation for Impella in high-risk percutaneous coronary intervention (HRPCI). The first patient was enrolled at Ascension St. John Hospital in Detroit by Dr. Ted Schreiber, chief of cardiology at Ascension St. John Macomb-Oakland Hospital and Dr. Amir Kaki, interventional cardiologist and director of mechanical circulatory support at Ascension St. John Hospital.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210415005234/en/
Impella Clinical Pathway to Class I Guideline (Graphic: Business Wire)
The two-arm trial will compare the benefits of HRPCI with Impella versus HRPCI without Impella support. The primary endpoint of the study is the composite of all-cause death, stroke, myocardial infarction (MI) or hospitalization for cardiovascular (CV) causes at a minimum of one year. The trial has an adaptive design. It aims to enroll 1,252 consecutive qualified patients at more than 100 hospital sites across the U.S. and Europe.
The PROTECT IV RCT will leverage advancements in technology and best practices learned since the completion of the PROTECT II RCT and the FDA pre-market approval (PMA) for Impella 2.5 for HRPCI. Data from PROTECT II found, when compared to intra-aortic balloon pump (IABP), Impella 2.5 led to a 29% reduction in MACCE, defined as composite of death, stroke, myocardial infarction and repeat procedures, at 90 days.
PROTECT IV also builds on PROTECT III, a contemporary, prospective, single-arm FDA post-approval study of Impella 2.5 and Impella CP for HRPCI. Interim results presented at TCT 2020 found a statistically significant improvement in 90-day MACCE rates versus PROTECT II (15.0% vs. 21.9%, p=.035) with lower in-hospital bleeding complications (1.8% vs. 12.5%, p<0.001) despite substantially sicker and more complex patients. Impella-supported PCI has shown higher rates of optimal and complete revascularization, which leads to improved long-term survival and quality of life.
“This trial aims to generate the highest level of scientific clinical evidence to definitively demonstrate that Impella-supported PCI improves outcomes for high-risk patients, and we are excited to enroll the first patient in the trial,” said Dr. Schreiber. “Dr. Kaki and I are proud of the entire team at Ascension St. John Hospital for being at the forefront of cardiovascular research in this landmark RCT.”
The trial’s principal investigators are Gregg W. Stone, MD, professor of medicine, professor of population health sciences and policy and director of academic affairs for the Mount Sinai Heart Health System, and co-director of medical research and education at The Cardiovascular Research Foundation and Stephan Windecker, MD, director and chief physician in the department of cardiology at the Swiss Cardiovascular Center in Bern, Switzerland.
“PROTECT IV is a landmark trial with the potential to revolutionize the interventional treatment of patients with complex coronary artery disease and left ventricular dysfunction,” said Dr. Stone. “This academically led study is designed to provide the highest level of robust evidence to guide management and improve global clinical outcomes for these high-risk patients.”
“This study is important for the field of interventional cardiology in that it will demonstrate whether forward flow unloading will protect the heart during a high-risk PCI, allowing for more complete revascularization and improved long-term outcomes,” said Dr. Windecker.
The PROTECT series of studies are sponsored by Abiomed as part of its commitment to improving clinical outcomes. To learn more about PROTECT IV, please visit HeartRecovery.com.
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.
In Europe, the Impella 2.5, Impella CP and Impella CP with SmartAssist are CE marked for treatment of high-risk PCI and AMI cardiogenic shock patients for up to 5 days. Impella 5.0 and Impella LD are CE marked to treat heart attack or cardiomyopathy patients in cardiogenic shock for up to 10 days. The Impella 5.5 with SmartAssist is CE marked to treat heart attack or cardiomyopathy patients in cardiogenic shock for up to 30 days. The Impella RP is CE marked to treat right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, open-heart surgery, or refractory ventricular arrhythmia.
To learn more about the Impella platform of heart pumps, including their approved indications and important safety and risk information associated with the use of the devices, please visit www.abiomed.com.
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
This press release contains forward-looking statements. 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/20210415005234/en/
Contact information
Media:
Sarah Lima
Communications Manager
978-882-8211
slima@abiomed.com
Investors:
Todd Trapp
Vice President and Chief Financial Officer
(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
Arini Announces Final Close of Inaugural Direct Lending Fund, Targeting Over $4 Billion of Deployment21.10.2026 10:00:00 EEST | Press release
Arini, an alternative asset manager with $22 billion in assets under management as of 31 August 2026, today announces the final close of Arini Direct Lending Fund I. The Fund and related vehicles are targeting deployment of over $4 billion, including anticipated leverage, making it among the largest debut European direct lending funds ever raised. Arini has built a sizeable initial portfolio throughout the fundraise, focusing on senior secured loans to borrowers demonstrating recurring and underwritable cash flow profiles and operating in industries with limited risk of disruption. Total deployment for the strategy is now approaching $2 billion across a range of sectors and geographies, alongside founder-led, family-owned and sponsor-backed businesses. This scale of deployment, in conjunction with Arini’s highly selective underwriting standards, demonstrates the depth of the European middle market opportunity set. Unlike in the US, banks in Europe have a dominant market share in corpor
Skechers Wins Major Victory Against Kizik in Patent Infringement Suit21.10.2026 10:00:00 EEST | Press release
Skechers U.S.A., Inc. (“Skechers”), the third largest footwear company in the world and leader in hands-free footwear technology, announced today that it won a major legal and commercial victory in a patent infringement lawsuit filed by Fast IP, LLC (“Kizik”) against Skechers before the Unified Patent Court (“UPC”) in Munich. Skechers, the market leader in hands-free footwear, sells thousands of styles of hands-free shoes worldwide under its Slip-ins and Swift Fit trademarks. In 2025, Kizik sued Skechers at the UPC for alleged patent infringement involving four of its thousands of hands-free styles. Skechers won on three of the four styles, with the fourth being a minor and commercially insignificant style for Skechers. In its ruling, the Munich Court stated that Kizik’s infringement claims are “largely unfounded.” Skechers’ leading hands-free footwear position globally is the result of its product innovation, transforming the century-old idea of hands-free footwear into a true modern
LemFi Launches Its Biggest Product Expansion Yet Alongside a New Global Brand, ‘Ambition has no passport’21.10.2026 10:00:00 EEST | Press release
LemFi, the financial platform for people building lives across borders, today announced the launch of its new global brand platform, “Ambition has no passport”, alongside a completely rebuilt app, launching the largest product expansion in its history. More than two million customers use LemFi to move money to more than 30 countries, with over $2 billion in monthly transaction volume, and the company plans to add more countries next year. The expanded platform now includes savings and credit in the UK, eSIMs in more than 100 destinations, alongside LemFi’s existing international payments service. People who move countries arrive with a career, a qualification and a savings record, only to find that almost none of it counts. A credit history rarely survives a border crossing. Around 304 million people now live outside the country where they were born, sending some $905 billion home each year. Yet many financial services remain designed around individual products or customers living thei
AI and Multichannel Communication Come to Italian Municipalities21.10.2026 10:00:00 EEST | Press release
ANCIcomunicare and Audiencerate are partnering to provide Italian municipalities and local authorities with a new platform dedicated to data management and multichannel communication. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261019549522/en/ ANCIcomunicare and Audiencerate launch a partnership to bring Italian municipalities a platform that simplifies data management and digital communication with citizens across all channels. The solution enables municipalities to manage, through a single digital system, communication campaigns aimed at citizens and businesses across multiple channels, including WhatsApp, SMS and e-mail. The platform also integrates Artificial Intelligence and Microsoft Copilot capabilities, designed to simplify content creation, campaign management and the personalization of communications. A solution designed for municipalities. The project aims to make advanced digital tools available to local auth
Okomera Announces a Commercial Agreement With Servier to Use Its Tumor Miniaturization Technology for Cancer Research21.10.2026 09:00:00 EEST | Press release
Okomera, a TechBio company pioneering personalized cancer care through a proprietary technology platform combining tumor mini-avatars, microfluidics, and AI-powered imaging, today announced the signing of a commercial agreement with Servier, an independent international pharmaceutical group, to use its technology in the development of new cancer treatments. With more than 90% of oncology drug candidates never reaching the market, identifying early on the therapeutic approaches most likely to succeed is a critical challenge for the pharmaceutical industry. Okomera’s technology helps precisely reduce this attrition, by steering development toward candidates that demonstrated real, measurable activity against tumors. This collaboration marks an important milestone for Okomera, which is signing its first commercial agreement with an international pharmaceutical group. Under the terms of the agreement, Servier will operate Okomera’s platform fully independently. Its teams will be able to ge
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