Business Wire

FDA Approves RECOVER IV Randomized Controlled Trial with Exception from Informed Consent (EFIC)

Share

Abiomed (Nasdaq: ABMD) announces two approvals from the U.S. Food and Drug Administration (FDA) related to clinical research of Impella heart pumps in acute myocardial infarction (AMI) cardiogenic shock patients.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220916005094/en/

To view this piece of content from mms.businesswire.com, please give your consent at the top of this page.

RECOVER IV is an on-label, two-arm RCT that is designed to provide the clinical evidence needed to achieve a Class I guideline recommendation for Impella use in AMI cardiogenic shock. (Graphic: Business Wire)

The FDA has approved the on-label RECOVER IV randomized controlled trial (RCT) for AMI cardiogenic shock patients. RECOVER IV is a two-arm trial that will assess whether percutaneous coronary intervention (PCI), with Impella support initiated prior to the PCI, is superior to PCI without Impella support.

“This landmark trial will be the culmination of over 20 years of research in the interventional therapy of AMI and will apply all the clinical advancements we have made to improve survival and heart recovery for AMI patients with cardiogenic shock as demonstrated in multiple prospective studies,” said William O’Neill, MD, medical director of the Center for Structural Heart Disease at Henry Ford Health and a RECOVER IV national co-principal investigator.

The primary endpoint of RECOVER IV is all-cause mortality at 30 days. Secondary endpoints include major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days, days alive out of the hospital at six months, recovery of left ventricular (LV) function, need for durable ventricular assist device (VAD) or heart transplant, and health-related quality of life as measured by responses to the Kansas City Cardiomyopathy Questionnaire (KCCQ) at one year. Abiomed’s goal in conducting the trial is to achieve a global AMI cardiogenic shock Class I guideline recommendation for Impella and related best practice protocols, including Impella implantation pre-PCI (see figure 1).

“I am optimistic that RECOVER IV will further demonstrate the benefits of hemodynamic support and best practice protocols. These benefits include ventricular unloading using Impella pre-PCI, reduced LV wall stress, reduced pulmonary congestion, increased collateral coronary blood flow, and enhanced cardio protection so that more AMI cardiogenic shock patients can survive and achieve native heart recovery. The heart team and field have evolved and understand how important myocardial recovery is for both AMI and AMI cardiogenic shock to reduce the growing epidemic of heart failure,” said Navin K. Kapur, MD, executive director of the Cardiovascular Center for Research and Innovation (CVCRI) at Tufts Medical Center and a national co-principal investigator for RECOVER IV.

FDA Approves and Closes RECOVER III Post-Approval Study

Additionally, the FDA has approved and closed Impella’s prospective AMI cardiogenic shock post-approval study (PAS), RECOVER III. This study gathered real-world evidence on AMI cardiogenic shock patients treated with Impella between 2017–2019, collecting detailed data including stages of cardiogenic shock, cardiac output and timing of implantation. RECOVER III fulfills Abiomed’s PAS requirement and the FDA’s approval and closure of RECOVER III further validates Impella as a safe and effective therapy for AMI cardiogenic shock.

Impella remains the only mechanical circulatory support (MCS) device that has received the FDA’s highest level of pre-market approval (PMA) and PAS regulatory approval for AMI cardiogenic shock. Based on RECOVER III, Impella’s label for AMI cardiogenic shock will be updated to reflect data for up to one-year post-procedure.

AMI Cardiogenic Shock Clinical History

AMI cardiogenic shock has one of the highest mortality rates in the field of medicine. The survival rate has remained approximately 50% for cardiogenic shock patients in SCAI stages D and E without Impella support and associated best practices. Survival alone in cardiogenic shock is no longer the gold standard. Multiple Impella best practice studies demonstrate greater than 70% survival with greater than 90% native heart recovery (see figure 2). Impella best practices, such as pre-PCI implantation (see figure 3), have been developed by the recognized physician experts in the field of circulatory support and published over the last decade in multiple clinical studies from the U.S., Germany, Italy and Japan. Heart recovery after AMI cardiogenic shock improves patient quality of life and makes Impella one of the most cost-effective therapies in the CMS Medicare population and in private insurance. In the U.S. alone, more than 200,000 patients are admitted to the hospital every year in cardiogenic shock.

FDA Regulatory History of AMI Cardiogenic Shock

Impella is the most studied heart pump in the history of the FDA (see figures 4 & 5)and has exclusive FDA PMA as a safe and effective therapy for cardiogenic shock, high-risk PCI and right heart failure. Since 2004, more than 1,200 peer-reviewed studies, including real-world evidence analyses, prospective clinical studies and RCTs have published about the clinical benefits of Impella.

Impella has been used to treat more than 235,000 patients globally and is included in 13 clinical society guidelines. In 2021, the European Society of Cardiology upgraded Impella to a Class IIa recommendation for the treatment of cardiogenic shock. The intra-aortic balloon (IAB) is currently Class III (harmful) for routine use in cardiogenic shock in Europe and Japan based on the IABP-SHOCK II RCT, which demonstrated IAB compared to inotropic therapy provided no benefit to survival or hemodynamic augmentation. In 2020, IAB became Class III (harmful) in the U.S. guideline recommendations for post-cardiotomy cardiogenic shock.

All MCS and ventricular assist devices (VADs) since 1992 were approved with single-arm studies compared to historical survival rates judged on objective performance criteria (OPC) due to the ethical and logistical challenges of randomizing critically ill patients requiring immediate hemodynamic augmentation. In 2008 and 2009, Abiomed attempted the FDA RECOVER II RCT, which compared Impella to IAB in AMI cardiogenic shock. RECOVER II enrolled only 1 patient in 15 months at more than 30 sites before being halted for logistical and ethical consent challenges and lack of enrollment.

The FDA granted Impella 510(k) clearance in 2008 and after multiple FDA and prospective physician-initiated studies, the FDA approved high-risk PCI in 2015, AMI cardiogenic shock in 2016 (see figure 6), and other forms of heart failure with cardiogenic shock in 2018. With the fulfillment of RECOVER III and approval of RECOVER IV RCT, Abiomed is pursuing an on-label study to strengthen the global guidelines and improve outcomes for patients.

Abiomed has sponsored and funded several AMI cardiogenic shock studies since 2006 (see figure 7), including the only FDA studies in this space. The difficulty randomizing AMI cardiogenic shock patients in execution has been demonstrated in multiple studies including IMPRESS in STEMI (n=18), IMPRESS in Cardiac Arrest (n=48), Seyfarth, et al. (n=26) and the Abiomed-sponsored FDA RECOVER II RCT (n=1). All these studies failed to randomize and were halted early for failure to enroll their designated numbers based on logistical and ethical consent challenges.

Recent FDA Regulatory Changes for Exception from Informed Consent (EFIC)

Randomizing patients in AMICS has been challenging because they require emergent care and are too sick to provide traditional informed consent to enroll in a trial. In 1996, the FDA created the exception from informed consent (EFIC) pathway for emergency clinical research. This pathway allows investigators to broadly educate a community about a trial, then enroll patients without consent from patients, their family or their legally authorized representatives.

In 2022, after engaging with the FDA on the RECOVER IV RCT study design, the FDA approved the RECOVER IV RCT study protocol, which includes the use of EFIC. This community awareness process is rare and only used when the patients being studied are experiencing a life-threatening medical condition causing serious deficiency of mental function. This is a significant milestone for the field and physician leaders. The next steps include local hospital Institutional Review Board (IRB) approvals and a commitment from physicians to randomize.

“This pivotal randomized trial is historic as the first to use EFIC community consent to enroll cardiogenic shock patients. I applaud the FDA for its partnership to help solve the consent challenges in cardiogenic shock RCTs and call on the physician community to enroll and randomize patients in RECOVER IV,” said Gregg W. Stone, MD, professor of medicine and director of academic affairs for the Mount Sinai Heart Health System in New York and study chair for RECOVER IV.

For more information on current best practices in treating AMI cardiogenic shock patients please click here.

For more information on the RECOVER IV RCT study please click here.

ABOUT IMPELLA HEART PUMPS

Impella 2.5® and Impella CP® with SmartAssist® 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.

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, U.S.A., Abiomed is a leading provider of medical technology that provides 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: http://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.

Contact information

Media Contact:
Jenny Leary
Associate Director, U.S. Communications
+1 (978) 882-8491
jleary@abiomed.com

Investor Contact:
Todd Trapp
Executive Vice President and Chief Financial Officer
+1 (978) 646-1680
ttrapp@abiomed.com

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

Blue Yonder Announces Binding Agreement To Acquire One Network Enterprises for Approximately $839 Million To Create Multi-Enterprise Supply Chain Ecosystem29.3.2024 13:13:00 CET | Press release

Blue Yonder, a leader in digital supply chain transformations, continues its forward momentum to revolutionize the supply chain and has today announced the signing of an agreement to acquire One Network Enterprises (One Network) for approximately $839 million, subject to adjustments. One Network, provider of the Digital Supply Chain Network™, is known for its autonomous and resilience services and is a leading global provider of intelligent control towers. Upon completion, Blue Yonder will be well positioned to serve customers’ needs across planning, execution, commerce, and networks. “Supply chains have become more complex, and as more and more companies reduce risk by diversifying sourcing of products globally, there is an increased demand for the sharing of information and resources across the whole value chain. This, along with increased disruptions and geopolitical risks, have put the pressure on organizations to build more resilient and robust supply chains,” said Duncan Angove,

Dubai Electricity and Water Authority PJSC Shareholders Approve Payment of AED 3.1 Billion in Dividends29.3.2024 13:12:00 CET | Press release

Dubai Electricity and Water Authority PJSC (ISIN: AED001801011) (Symbol: DEWA), the Emirate of Dubai’s exclusive electricity and water services provider and majority owner of the largest cooling services provider, which is listed on the Dubai Financial Market (DFM), reported that its shareholders have, in the general assembly held on March 28th, 2024, approved the payment of total dividend of AED 3.1 billion with a record date of April 8th, 2024. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240329162756/en/ Dubai Electricity and Water Authority PJSC shareholders approve payment of AED 3.1 billion in dividends (Photo: AETOSWire) General Assembly Details The meeting, chaired by HE Matar Humaid Al Tayer, Chairman of the Board of Directors of DEWA, was attended by HE Saeed Mohammed Al Tayer, MD & CEO of DEWA and Members of the Board of Directors of DEWA as well as 85.9% of the shareholders. The assembly was held on Thursday (2

PAN Finance Names Libertex ‘Global CFD Broker of the Year’29.3.2024 06:25:00 CET | Press release

As the first quarter of 2024 draws to a close, Libertex is thrilled to announce its first accolade of the new year! The established global financial publication PAN Finance has determined Libertex to be the ‘CFD Broker of the Year – Global 2024’ following a rigorous evaluation process conducted by the publication's highly experienced editorial and research teams. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240328235325/en/ (Graphic: Libertex) PAN Finance is a trusted source of global financial intelligence with an impressively wide readership across 150 countries. Its ecosystem includes a quarterly magazine, special reports, a news website, and various social media channels. As an organisation, PAN Finance is committed to providing concise, intelligent, and up-to-date news for a worldwide readership of specialists spanning the entire finance industry. The company's awards programme aims to serve as a true indicator of exc

Midea Group releases its first-ever ESG brand story with an unexpected VIP visit highlighting its commitment to sustainability.29.3.2024 02:39:00 CET | Press release

Midea Group: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240328526418/en/ Background: Midea Group, a leading global technology group, recently released its 2023 Environmental, Social, and Governance (ESG) Report with ambitious sustainable development goals set for 2030. They include achieving over 500 megawatts of photovoltaic power generation, reducing greenhouse gas emission intensity (scopes 1 and 2) by 0.040, secure Energy Management System Certification for 50 factories, and achieve 100% carbon footprint accounting for major categories of smart home appliances. This is aligned with the Sustainable Development Report Standards of the Global Report Standards of the Global Reporting Initiative (GRI). The new report and campaign focuses on four dimensions: Protect the Blue Planet, Build a Harmonious Community, Practice 'Bring Great Innovations to Life', and Jointly Create the Prosperous Ecology. The campaign: Midea’s ESG

DC Secretary Announces Annual Determinations Committees Outcome28.3.2024 21:14:00 CET | Press release

DC Administration Services, Inc. has today announced the composition of five regional Determinations Committees (DCs), effective from April 27, 2024. Voting Dealers (for all regions): Voting Non-Dealers (for all regions): Bank of America N.A. Citadel LLC Barclays Bank plc Elliott Management Corporation BNP Paribas Pacific Investment Management Company LLC Citibank, N.A. Deutsche Bank AG Goldman Sachs International JPMorgan Chase Bank, N.A. Voting Dealer for the Americas, EMEA, AEJ, and Japan Determination Committees: Mizuho Securities Co., Ltd. The process for selecting DC members is specified in the DC rules. The DC rules, along with more information about the Determinations Committees and what they do can be found at the Determinations Committees website: https://www.cdsdeterminationscommittees.org/. View source version on businesswire.com: https://www.businesswire.com/news/home/20240328441002/en/Contact information Press Inquiries: Orlando Figueroa orlando.figueroa@citadelspv.com

HiddenA line styled icon from Orion Icon Library.Eye