Abiomed announces European approval for Impella 5.5; treatment of first patient
Abiomed (ABMD) 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 further enhances Abiomed’s product portfolio and provides physicians a 30-day, ambulatory, wean-able, forward flow heart pump.
Under the leadership of Professor Hermann Reichenspurner, MD, PhD, Alexander Bernhardt, MD treated the first patient, who presented with ischemic cardiomyopathy, severe mitral regurgitation and an ejection fraction of 18%.
The patient currently remains stable on Impella 5.5 support.
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 is approved in Europe for up to 30 days of support and can be adjusted to nine power levels that regulate flow to optimize weaning protocols.
The Impella 5.5 device includes the new SmartAssist technology with optical sensor, which will enable the integration of clinical data informatics including Left Ventricular Pressure, End-Diastolic Pressure and Cardiac Power Output on the Impella console as well as real-time, exact positioning of the Impella device.
Over the next fiscal 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 our German hospitals submitting clinical data in the global cVAD Registry study.
ABMD closed at $278.07.
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