Medtech Winners of 2015: Abiomed

AbiomedAbiomed won PMA approval for its Impella 2.5 heart pump through FDA’s 515 initiative.

December 15, 2015

1 Min Read
Medtech Winners of 2015: Abiomed

The news has been nothing but positive this year for Abiomed, maker of a temporary ventricular assist device delivered percutaneously to the heart.

Early in the year, Abiomed won HDE approval for its Impella RP System for right heart support. That was soon followed by PMA approval for the Impella 2.5 heart pump for use during elective and urgent percutaneous coronary interventions. The pump has been commercially available for years under a 510(k) clearance but was submitted for PMA approval under FDA’s 515 initiative.

In June, the U.S. Department of Justice closed an investigation into Impella 2.5 marketing without taking any action. And at an annual investor meeting in August, management disclosed plans for future products, including an Impella Bridge to Recovery that could support patients for months to years after leaving the hospital. Meanwhile, the company’s management team has reported strong year-over-year growth in patient utilization of the Impella technology every quarter this year.

As a result of all the good news and strong adoption, the company’s stock price soared from $37 at the beginning of the year to around $80 in mid-November. 

[image courtesy of ABIOMED]

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