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

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

Versace Chooses Board to Transform Retail Planning29.9.2022 13:22:00 EEST | Press release

Board, the leading global provider of Intelligent Planning Solutions which help organizations plan smarter — enabling actionable insights and better outcomes, today announced that Versace, the Italian fashion house that symbolizes luxury worldwide, has chosen Board to transform its Retail Planning. The Versace Group distributes its products through a direct network of over 200 owned boutiques and 1,500 distributors worldwide, with a turnover of more than one billion euros. Due to evolving challenges of global sourcing and the change in consumer purchasing habits, Versace recently revamped its retail strategy by opening new stores, strengthening their multi-channel approach and increasing investments in the efficiency of crucial business planning processes. "Board’s Intelligent Planning platform, provides the flexible and easy to use solutions necessary to support the innovation and growth of our brand,” said Francesco Loporcaro, IT Manager at Versace “Our selection of Board was influen

Satellogic Signs Three-Year Agreement with Government of Albania to Access Dedicated Satellite Constellation29.9.2022 13:00:00 EEST | Press release

Satellogic Inc. (NASDAQ: SATL), a leader in sub-meter resolution Earth Observation (“EO”) data collection, announced today that it has reached a three-year agreement with the Government of Albania to develop a Dedicated Satellite Constellation. This unique program derives from Satellogic’s Constellation-as-a-Service model and will provide Albania with responsive satellite imagery capabilities across its sovereign territory. Satellogic’s unique offering enables municipal, state, and national governments to manage a fleet of satellites over a specific area of interest and develop an EO imaging program at unmatched frequency, resolution, and cost. Satellogic will enable ​​Albania to address pressing issues involving agriculture management, illegal crops, illegal construction activity, traffic management, wildfire monitoring, border security, and environmental monitoring through high-quality imagery with country-wide capacity at a cost-effective price point. Albania will have priority acce

Burjeel Holdings Lights Up Burj Khalifa With New Campaign Featuring Shah Rukh Khan29.9.2022 12:27:00 EEST | Press release

A month ahead of his birthday, Indian actor Shah Rukh Khan lit up the world’s tallest building, The Burj Khalifa, on Wednesday evening, in a brand campaign for the UAE-based conglomerate Burjeel Holdings. For the past few years, on Shah Rukh Khan’s birthday, the Burj Khalifa has lit up in honor of the superstar. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220929005378/en/ The brand campaign of Burjeel Holdings featuring Shah Rukh Khan premiering at Burj Khalifa on Wednesday evening (Photo: AETOSWire) Shah Rukh Khan is the face of the group that owns 39 hospitals and medical centers under the Burjeel, Medeor, LLH, Lifecare, and Tajmeel brands in the UAE and Oman. The campaign, ‘We Are Committed To Your Care’, which is set to appear region-wide on multiple platforms features the Abu Dhabi-headquartered healthcare powerhouse’s homegrown success story. It is based on the group’s vision of connecting care, scale & community in

Brigade-M3 European Acquisition Corp. 2022 Semi-Annual Report29.9.2022 09:00:00 EEST | Press release

Brigade-M3 European Acquisition Corp. (the “Company”), a special purpose acquisition company that was incorporated on 21 April 2021 under the laws of the Cayman Islands as an exempted company with limited liability and is listed on Euronext Amsterdam, today published its semi-annual report for the period 1 January 2022 to 30 June 2022. The semi-annual report can be downloaded from the Company’s website via the following link: https://www.brigadem3eac.com/documents IMPORTANT INFORMATION This press release contains information that qualifies as inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation. DISCLAIMER This announcement is not for distribution or release, directly or indirectly, and should not be distributed in or sent into, the United States, Australia, Canada, Japan, the Cayman Islands or South Africa or any other jurisdiction in which such distribution or release would be unlawful or would require registration or other measures. The Company’s s

The LYCRA Company Announces Collaboration With Qore® to Use QIRA® for Next Generation Bio-derived LYCRA® Fiber at Scale29.9.2022 03:00:00 EEST | Press release

The LYCRA Company, a global leader in developing innovative fiber and technology solutions for the textile and apparel industry, today announced it has entered into an agreement with Qore® to enable the world’s first large-scale commercial production of bio-derived spandex using QIRA®, the next generation 1,4-butanediol (BDO), as one of its main ingredients. This will result in 70% of the LYCRA® fiber content being derived from annually renewable feedstock. This change could potentially reduce the carbon footprint of LYCRA® fiber by up to 44%* versus equivalent product made from fossil-based resources, while maintaining the same high-quality performance parameters of traditional LYCRA® fiber. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220928005020/en/ The LYCRA Company signs an agreement with Qore® LLC to enable large-scale production of bio-derived spandex. Pictured – Julien Born, CEO of The LYCRA Company (left), and Jo

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