Abiomed Wins 2 FDA Nods for Clinical Trials

With the Transcatheter Cardiovascular Therapeutics (TCT) symposium firmly at the forefront, news relating to FDA nods for cardiovascular companies seems to be pouring in.

Abiomed announced two approvals from FDA related to clinical research of the Impella heart pumps in acute myocardial infarction (AMI) cardiogenic shock patients.

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.

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 a 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 said its 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.

FDA also 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.

On Thursday, Edwards Lifesciences announced winning a nod from FDA for the Pascal Precision valve repair system for transcatheter edge-to-edge repair (TEER). The device is designed to be used in the treatment of patients with degenerative mitral regurgitation (DMR).