ABIOMED surged after announcing that it received a pre-market approval (PMA) for its Impella 2.5 heart pump device from the U.S. Food and Drug Administration (FDA).
The stock price of ABIOMED were trading more than 15% to $71.23 per share at the time of this writing, around 12:20 in the afternoon in New York.
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ABIOMED’s most significant milestone
Michael R. Minogue, Chairman and CEO of ABIOMED said the FDA approval for the Impella 2.5 heart pump device is one of the most significant milestones achieved by the company.
“As heart disease patients get sicker, more complex, and desire minimally invasive solutions, there are few options available to them to help improve their quality of life in a cost-effective manner. We are excited that Impella has been recognized as a device that can potentially become the new standard of care with a ‘first of its kind’ approval.”
The Impella 2.5 System
ABIOMED is a provider of breakthrough heart support technologies. The Impella 2.5 heart pump helps patients maintain a stable heart function and circulation during elective and urgent high-risk percutaneous coronary intervention (PCI) procedures.
According to the ABIOMED, the Impella 2.5 is the world’s smallest heart pump. It is also the first hemodynamic support device to receive a PMA approval for use during high-risk PCI procedures, which demonstrates its safety and efficacy.
The Impella 2.5 is a temporary (? 6 hours) ventricular support device for stable patients with severe coronary artery disease and depressed left ventricular ejection fraction during high-risk PCI procedures.
ABIOMED explained that using the heart pump may prevent hemodynamic instability that may happen to patients during planned temporary occlusions. It may also reduce pre and post-procedural adverse events.
William O’Neill, M.D. at Henry Ford Hospital in Detroit said, “The rigorous data from FDA clinical trials such as PROTECT I and PROTECT II demonstrate that complex, high-risk patients undergoing protected PCI with Impella 2.5 support experience reduced adverse events, improved quality of life and can return home faster with fewer repeat procedures.”