Abiomed (NASDAQ:ABMD) surged in today’s trading after the provider of mechanical circulatory support devices said its miniature blood pump system that maintains heart function and circulation received approval from the U.S. Food and Drug Administration.
Shares soared 17 percent to $71.14 at 3:37 p.m. in Toronto. The stock has nearly tripled over the past six months.
The device, Impella 2.5 System, can be used during angioplasty and stenting, the regulator said.
Angioplasty and stenting are procedures used to re-open arteries in the heart that are blocked due to coronary artery disease, a condition that is the leading cause of death in the United States.
The FDA said data showed few later adverse events in patients using the pump during procedures, compared to those using the conventional intra-aortic balloon pump.
The Impella 2.5 System draws blood from the left lower chamber of the heart and pumps it to the main blood vessel to maintain stable heart function.
The device can be used in patients who have severe coronary artery disease but are not candidates for bypass treatment, the regulator said.
“The FDA approval of the Impella 2.5 device is one of our most significant milestones, representing a clinical advancement for physicians and patients,” the company’s chief executive officer Michael Minogue said in a statement. “The FDA's recognition of this elective and urgent patient population is an important acknowledgement of their growing need for treatment.”