Abiomed reported that physicians have implanted more than 20,000 Impella pumps in U.S. patients requiring hemodynamic support. To date, the higher flow Impella CP has been implanted in over 3,000 U.S. patients, the company noted. The Impella RP recently received CE Marking approval in the European Union and also completed patient enrollment in its Investigational Device Exemption trial, RECOVER RIGHT, with an extended Continuous Access Protocol to allow the company to continue enrolling an additional 22 patients into the trial for further evaluation. FDA approval for the Impella RP is expected by early 2015, Abiomed said.
- Health Care Industry