ABIOMED Inc.’s Impella 5.5 heart pump received CE Mark approval in Europe. Notably, the first patient at University Heart Center in Hamburg, Germany, was successfully treated with the Impella, under the surveillance of Professor Hermann Reichenspurner. The patient was diagnosed with ischemic cardiomyopathy and severe mitral regurgitation.
Over 3000 patients with axillary implants treated with the Impella 5.0 were studied and the clinical data was submitted for the CE marking. It included an analysis of 68 patients from Abiomed's FDA reviewed cVAD Registry study, who were treated with Impella 5.0 or Impella LD heart pumps.
Notably, ABIOMED’s coveted Impella line, used to treat heart attack, has previously received a series of regulatory approvals and contributed significantly to the company’s earnings in and outside the United States.
The approval is likely to fortify ABIOMED’s foothold in the field of heart recovery, in Europe.
Why Impella 5.5?
Impella 5.5 is an intracardiac heart pump, used for supporting the left ventricle. It is used for treating patients with reduced left ventricular function or with limited preoperative ejection fraction.
Per management, the device addresses the clinical needs of patients and physicians. The minimally-invasive device is easy to implant and is capable of stabilizing the patient by increasing the cardiac power output.
Per University Heart Center, Impella 5.5 is an introduction in the cardiovascular community for effectively treating severely ill patients.
Cardiovascular Disease Trends in Europe
Per a study by European Heart Network, cardiovascular disease causes 3.9 million deaths each year in Europe, accounting for 45% of total annual deaths.
Smoking and increasing cases of obesity continue to be the major causes for such deaths.
Price Performance
In the past year, shares of ABIOMED have gained a whopping 129.9%, compared with the
industry’s rally of 23.2%.
Zacks Ranks & Other Key Picks
ABIOMED carries a Zacks Rank #2 (Buy).
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ABIOMED's (ABMD) Impella 5.5 Receives CE Mark in Europe