07.29.15
The U.S. Department of Justice (DOJ) has closed an investigation into Abiomed Inc.’s marketing of the Impella 2.5 device. The DOJ will not be taking any enforcement action.
“We are pleased that the Department of Justice has chosen to close its investigation without pursuing any further action and that this matter is now behind us. We have always remained steadfast in our integrity and our commitment to putting our patients first,” said Michael R. Minogue, chairman, president and CEO of Danvers, Mass.-based Abiomed.
On Oct. 26, 2012, Abiomed was informed that the United States Attorney’s Office for the District of Columbia had initiated an investigation and was seeking documents from the company related to its marketing and labeling of the Impella 2.5.
Abiomed has cooperated fully with the government inquiry since its inception.
The company has been riding a wave of good news in recent months. A June news item in the Boston Business Journal said Abiomed is planning a massive expansion thanks to recent U.S. Food and Drug Administration (FDA) approvals, adding employees and space to increase its manufacturing.
In March, the company received FDA premarket approval for Impella 2.5 heart pump for elective and urgent high-risk percutaneous coronary intervention procedures. Impella 2.5, which the company claims is the world’s smallest heart pump, is the first hemodynamic support device to receive such a nod from the agency. About 100,000 patients suffering from cardiac problems in the United States are declared unfit for heart surgery due to extreme risks associated with the procedures. The Impella 2.5 pump changes care options for those patients.
Delivered through a catheter requiring only a small hole in the leg, the Impella RP is FDA indicated for providing circulatory assistance for up to 14 days in pediatric or adult patients who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. These patients lack blood flow from the right side of their hearts. The Impella RP is designed to provide the flow and pressure needed to compensate for right heart failure. The device does not require a surgical procedure for insertion, and it provides up to four liters per minute of hemodynamic support.
“We are pleased that the Department of Justice has chosen to close its investigation without pursuing any further action and that this matter is now behind us. We have always remained steadfast in our integrity and our commitment to putting our patients first,” said Michael R. Minogue, chairman, president and CEO of Danvers, Mass.-based Abiomed.
On Oct. 26, 2012, Abiomed was informed that the United States Attorney’s Office for the District of Columbia had initiated an investigation and was seeking documents from the company related to its marketing and labeling of the Impella 2.5.
Abiomed has cooperated fully with the government inquiry since its inception.
The company has been riding a wave of good news in recent months. A June news item in the Boston Business Journal said Abiomed is planning a massive expansion thanks to recent U.S. Food and Drug Administration (FDA) approvals, adding employees and space to increase its manufacturing.
In March, the company received FDA premarket approval for Impella 2.5 heart pump for elective and urgent high-risk percutaneous coronary intervention procedures. Impella 2.5, which the company claims is the world’s smallest heart pump, is the first hemodynamic support device to receive such a nod from the agency. About 100,000 patients suffering from cardiac problems in the United States are declared unfit for heart surgery due to extreme risks associated with the procedures. The Impella 2.5 pump changes care options for those patients.
Delivered through a catheter requiring only a small hole in the leg, the Impella RP is FDA indicated for providing circulatory assistance for up to 14 days in pediatric or adult patients who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. These patients lack blood flow from the right side of their hearts. The Impella RP is designed to provide the flow and pressure needed to compensate for right heart failure. The device does not require a surgical procedure for insertion, and it provides up to four liters per minute of hemodynamic support.