MA-ABIOMED
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/
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210415005234/en/
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
Deciphera Announces Oral Presentation of Positive Topline Results from Phase 2a Study of Sapablursen in Polycythemia Vera at the 67th American Society of Hematology (ASH) Annual Meeting6.12.2025 15:30:00 CET | Press release
Results from Phase 2a IMPRSSION study demonstrate sapablursen significantly reduced phlebotomy rate, controlled hematocrit and increased serum hepcidin Sapablursen was generally safe and well tolerated Results support further development of sapablursen in a Phase 3 study Deciphera Pharmaceuticals, a member of Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “Ono”), today announced the oral presentation of positive results from the Phase 2a IMPRSSION study of sapablursen in patients with polycythemia vera (PV) at the 67th American Society of Hematology (ASH) Annual Meeting, taking place December 6-9, 2025, in Orlando, FL. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251206361611/en/ The results were presented by Ionis Pharmaceuticals, who discovered and developed sapablursen and conducted the IMPRSSION study. In March 2025, Ionis and Ono entered into a license agreement in which On
Protagonist and Takeda Present Longer-Term Data at ASH 2025 Showing Rusfertide Delivers Durable Response and Hematocrit Control in Polycythemia Vera6.12.2025 15:30:00 CET | Press release
52-Week Results from the Phase 3 VERIFY Study of Rusfertide Demonstrated Sustained Hematocrit Control and Response, Defined by Absence of Phlebotomy Eligibility, with No New Safety SignalsThese Data Build on Positive 32-Week Primary Analysis from VERIFY, Which Met its Primary Efficacy Endpoint and All Four Key Secondary EndpointsPatients Crossing Over from Placebo to Rusfertide at 32 Weeks Achieved a Similar Response Rate to Those Initially Randomized to Rusfertide, with 77.9% Achieving Absence of Phlebotomy Eligibility Between Weeks 40-52Four-Year Results from the Combined REVIVE and Long-Term Extension THRIVE Study Demonstrated a 13-Fold Reduction in Annual Rate of Phlebotomies from Baseline Protagonist Therapeutics, Inc. (“Protagonist”) (NASDAQ:PTGX) and Takeda (TSE:4502/NYSE:TAK) announce that new 52-week results from the pivotal Phase 3 VERIFY study evaluating rusfertide in patients with polycythemia vera (PV) will be presented in an oral presentation at the 67th American Society
Vertex Presents New Data on CASGEVY®, Including First-Ever Data in Children Ages 5-11 Years, at the American Society of Hematology Annual Meeting and Announces Plan for Global Regulatory Submissions6.12.2025 13:01:00 CET | Press release
- Data from pivotal studies of CASGEVY in children ages 5-11 years with severe sickle cell disease or transfusion-dependent beta thalassemia demonstrates the transformative potential of the therapy in younger patients -- Efficacy and safety data in children 5-11 years are consistent with the durable and positive benefit/risk profile established from clinical studies in patients 12 years of age and older -- Vertex expects to initiate global regulatory submissions for CASGEVY in children 5-11 years in 1H 2026 - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced data from multiple studies demonstrating the clinical benefits of CASGEVY® (exagamglogene autotemcel) in people ages 5 years and older living with severe sickle cell disease (SCD) or transfusion-dependent beta thalassemia (TDT). The results, including the first presentation of clinical data from pivotal studies in children ages 5-11 years, and longer-term data from the pivotal studies of people with severe SCD and
Leading Global Scientists Gather at Tengchong Scientists Forum to Explore Innovative Pathways in Frontier Technologies6.12.2025 12:31:00 CET | Press release
The 2025 Tengchong Scientists Forum opened on Saturday in southwest China’s Yunnan Province, convening leading scientists and academic figures to examine innovation across frontier fields including artificial intelligence, biodiversity and quantum technology. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251205499197/en/ Opening ceremony of Tengchong Scientists Forum on 6th December, 2025 Notable participants include Nobel Physics laureate Konstantin Novoselov, Fields Medalist Efim Zelmanov and Turing Award winner Andrew Chi-Chih Yao, who join 127 academicians, 77 university presidents from China and abroad, over 400 scholars and more than 600 entrepreneurs and financiers. The gathering aims to deepen collaboration between cutting-edge research and industrial development. Under the theme “Science · AI changing the World,” the forum features ten sub-forums, academic sessions and thematic events supporting major cooperation p
Lattice Wins 2025 Global Semiconductor Alliance Award6.12.2025 00:49:00 CET | Press release
‒ Named Most Respected Public Semiconductor Company Achieving $100 Million to $500 Million in Annual Sales ‒ Lattice Semiconductor (NASDAQ: LSCC), the low power programmable leader, today announced that it was selected as ‘Most Respected Public Semiconductor Company’ at the 2025 Global Semiconductor Alliance (GSA) Awards. The GSA awards recognize companies that have demonstrated excellence through their success, vision, strategy, and future opportunities in the industry as determined by votes from GSA members. “We are honored to be recognized by the Global Semiconductor Alliance and our peers as one of 2025’s most respected public semiconductor companies. This recognition reflects the dedication of the Lattice team and the trust of our customers, partners, suppliers, and investors. Looking ahead, we remain laser-focused on driving innovation and strengthening our role as the trusted low power programmable leader for semiconductor and system solutions,” said Ford Tamer, Chief Executive
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