Abiomed has received an expanded US FDA premarket approval for the Impella 2.5 and Impella CP heart pumps during elective and urgent high-risk percutaneous coronary intervention (PCI) procedures. A press release reports that this expanded indication confirms Impella support as appropriate in patients with severe coronary artery disease, complex anatomy and extensive comorbidities, with or without depressed ejection fraction.
Impella’s initial approval for high-risk PCI was based on two FDA studies (PROTECT I and PROTECT II) that treated the sickest and most severe patients in the catheterisation lab with the majority being denied open heart surgery. According to the press release, the expanded indication broadens the appropriate use of Impella support and eliminates the requirement for depressed ejection fraction in the presence of severe coronary artery disease or complex anatomy (e.g., left main, multivessel, or requiring rotational atherectomy).
With this expanded approval, the FDA has further validated this “first-of-its-kind” indication for high-risk PCI and the benefit of percutaneous haemodynamic support in treating severely complex patients with mild, moderate and severely depressed ejection fraction. Clinical society guidelines from the ACC/HFSA/SCAI/STS consensus publication support the use of Impella in patients with reduced or normal left ventricular function and severe coronary artery disease for treatment of anticipated technically challenging or prolonged PCI patients.
The Impella 2.5 and Impella CP heart pumps are the only percutaneous temporary ventricular support devices FDA-approved as safe and effective for high-risk PCI, with the new indication stated below:
The Impella 2.5 and Impella CP are indicated for providing temporary (<6 hours) ventricular support during elective or urgent high-risk PCI performed in haemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 and the Impella CP in these patients may prevent haemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.
Ehtisham Mahmud (Sulpizio Cardiovascular Center, UC San Diego, San Diego, USA) says: “This expanded FDA approval with moderately reduced ejection fraction validates our real-world experience using haemodynamic support in patients turned down for surgery with severe coronary artery disease. These patients who have often been managed medically in the past may have a new option for treatment.”