FDA indication expanded for Impella CP heart pump during percutaneous coronary interventions- Abiomed

Abiomed has expanded its FDA pre-market approval (PMA) for Impella heart pump use in high-risk percutaneous coronary interventions (PCI) to include the Impella CP heart pump. The Impella 2.5 and Impella CP now offer temporary (less than 6 hours) ventricular support systems indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, 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 Impella CP in these patients may prevent hemodynamic 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.

Data submitted from an FDA IDE approved, randomized multicenter trial (Protect II) demonstrated that Protected PCI with Impella heart pumps reduced major adverse events (MACCE) by 29 percent, increased patient quality of life by 58 percent, and showed superior hemodynamics and improved cardiac power over the control arm (IABP). Additionally, multiple independent analyses reveal Impella usage is cost effective (ICER) or dominant (lowers absolute costs) in emergency patients. Benefits from Impella-supported procedures may also include a reduction in symptoms and class of heart failure, reduction of days in the hospital, and a reduction in readmissions due to fewer repeat procedures. In addition to the data submitted for the Impella 2.5 approval, including the FDA safety study PROTECT I and the Randomized Controlled Trial PROTECT II, the results from a retrospective data review of 72 patients supported with Impella CP and 637 patients treated with Impella 2.5 were submitted. Post-market surveillance will be conducted through the cVAD Registry.