Impella 5.5 heart pump receives CE marking approval in Europe for heart failure.- Abiomed.

Abiomed has announced that the Impella 5.5 heart pump received CE marking approval in Europe and the first patient was treated at University Heart Center in Hamburg, Germany. The Impella 5.5 heart pump provides physicians a 30-day, ambulatory, wean-able, forward flow heart pump.

The data submitted for the CE marking approval included pre-clinical data on the Impella 5.5 and incorporates the clinical experience from over 3,000 patients, most all with axillary implants treated with the Impella 5.0 device. The submission also included an analysis of 68 patients from Abiomed's FDA reviewed cVAD Registry study treated with Impella 5.0 or Impella LD heart pumps and a literature review of eight papers identifying patients treated with the Impella 5.0. Additionally, Abiomed submitted an analysis of 17 patients enrolled in the RECOVER I prospective, multicenter FDA IDE study.

The Impella 5.5 heart pump has the ability to provide peak flows of greater than 6.0 liters per minute. It is designed to be implanted in the axillary artery, avoiding the need for a sternotomy and allowing for patient ambulation. The Impella 5.5 can be adjusted to nine power levels that regulate flow to optimize weaning protocols and includes SmartAssist technology with optical sensor, which will enable the integration of clinical data informatics including Left Ventricular Pressure (LVP), End-Diastolic Pressure (EDP) and Cardiac Power Output (CPO) on the Impella console as well as real-time, exact positioning of the Impella device. Over the next year, Abiomed plans to launch the Impella 5.5 heart pump through a controlled roll-out at German hospitals with established heart recovery protocols. Abiomed will continue to collect data on Impella 5.5 user experience and patient outcomes through German hospitals submitting clinical data in the global cVAD Registry study.