Abiomed Receives FDA PMA Approval for Impella RP® for Right Heart Failure - Seite 2

"The Impella RP has opened up a new era in cardiovascular medicine. With its percutaneous, single vascular access, the Impella RP offers physicians a minimally-invasive procedure for patients who have previously had limited options for treatment of right heart failure," said Mark B. Anderson, M.D., FASC, co-principle investigator for the RECOVER RIGHT trial and vice chair of cardiac surgery services and cardiothoracic surgeon to the Hackensack University Medical Group. "The cumulative data from the FDA studies demonstrate that Impella RP potentially offers survival benefits for these critically ill patients in need of hemodynamic support."

"This latest PMA approval for Impella RP enables physicians for the first time to percutaneously treat a broader population of patients with right heart failure," said Michael R. Minogue, President, Chairman and CEO of Abiomed. "Abiomed would like to recognize the FDA as well as our physicians, scientists and employees for the extensive clinical research and review that allowed this FDA PMA approval. Abiomed now offers a platform of minimally-invasive devices that support both sides of the heart to enable heart recovery and we are committed to education and training for the entire heart team as we move to full commercial availability."

1. Anderson MB, Goldstein J, Milano C, et al. Benefits of a novel percutaneous ventricular assist device for right heart failure: The prospective RECOVER RIGHT study of the Impella RP device. J Heart Lung Transplant. 2015; 34(12):1549-1560.
2. Anderson, MB, et al. Impella RP Post Approval Study: First Multi-Center, Prospective Post Market Approval Results for the Impella RP in Patients with Right Ventricular Failure. J Heart Lung Transplant. 2017; 36(4):S64-S65.

ABOUT IMPELLA HEART PUMPS

Abiomed's right-side heart pump, the Impella RP^® device, is FDA approved to treat patients experiencing acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. The Impella 2.5^®, Impella CP^® and Impella 5.0^® are FDA-approved heart pumps used to treat heart attack patients in cardiogenic shock, and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart. The Impella 2.5 and Impella CP devices are also approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI) such as stenting or balloon angioplasty, to re-open blocked coronary arteries. To learn more about the Impella platform of heart pumps, including their approved indications and important safety and risk information associated with the use of the devices, please visit: www.protectedpci.com.