ABIOMED, Inc. (NASDAQ:ABMD) Awarded CE Mark Approval For Impella 5.5 Heart Pump In Europe


ABIOMED, Inc. (NASDAQ:ABMD) has announced that its Impella 5.5 heart pump has been given a CE Mark Approval in Europe following its first successful use in treating a patient.

The Impella 5.5 heart pump was put to the test at the University Heart Center located in Hamburg, Germany where it was successfully used to treat a patient. The heart pump was used under the supervision of Professor Hermann Reichenspurner and the patient involved had been diagnosed with severe mitral regurgitation as well as ischemic cardiomyopathy. The patient has reportedly been stable with the aid of Impella 5.5.

The Impella 5.5 pump can facilitate peak flows of more than 6 liters per minute which is quite impressive. The device is designed such that it can be fitted in the axillary artery, thus making room for patient ambulation eliminating the need for a sternotomy. The device has received approval in Europe for up to 30 days of support. Additionally, the pump offers flexibility through nine levels of power adjustments, thus making it easy to regulate flow.

The Impella 5.5 device also features SmartAssist technology which includes an optical sensor that can be used to facilitate the integration of clinical data such as Cardiac Power Output (CPO), End-Diastolic Pressure (EDP), and Left Ventricular Pressure (LVP). The information is accessible in real time through the Impella console. It also allows the user to determine the exact positioning of the pump.

“The Impella 5.5 device is an easy to implant, minimally-invasive device that provides full cardiac flow and stabilizes the patient by increasing cardiac power output, unloading the left ventricle and perfusing the coronaries and end organs,” stated Professor Hermann Reichenspurner, the head of Cardiovascular Surgery at the University Heart Center in Hamburg.

Abiomed has plans to carry out a controlled rollout of the heart pump over the next one year in German hospitals especially those that have already established heart recovery procedures. The roll-outs will also allow the company to collect more data about the user experience for the patients as well as the outcomes. The hospitals will submit clinical data as part of the global cVAD Registry study and the submitted data will be used to support applications for approval in other markets.

Abiomed stock closed the latest trading session on Thursday at $292.13.


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