Research & Development
FDA Approves RECOVER IV Randomized Controlled Trial with Exception from Informed Consent
16 September 2022 - - US-based medical technology company Abiomed (NASDAQ: ABMD) has received two approvals from the US Food and Drug Administration related to clinical research of Impella heart pumps in acute myocardial infarction cardiogenic shock patients, the company said.

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

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 function, need for durable ventricular assist device or heart transplant, and health-related quality of life as measured by responses to the Kansas City Cardiomyopathy Questionnaire 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.

Additionally, the FDA has approved and closed Impella's prospective AMI cardiogenic shock post-approval study, 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 device that has received the FDA's highest level of pre-market approval 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 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.

Impella best practices, such as pre-PCI implantation, 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 US, 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 US alone, more than 200,000 patients are admitted to the hospital every year in cardiogenic shock.

Impella is the most studied heart pump in the history of the FDA 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 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 US guideline recommendations for post-cardiotomy cardiogenic shock.

All MCS and ventricular assist devices since 1992 were approved with single-arm studies compared to historical survival rates judged on objective performance criteria 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, 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, including the only FDA studies in this space.


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