Abiomed (NSDQ:ABMD) said today it won expanded FDA premarket approval for its Impella 2.5, Impella CP, Impella 5.0 and Impella LD heart pumps, now cleared to provide treatment for heart failure associated with cardiomyopathy leading to cardiogenic shock, including peripartum and postpartum cardiomyopathy.
The approval follows a previous FDA indication the Danvers, Mass.-based company won in April 2016 that cleared the device for treating acute myocardial infarction cardiogenic shock and post-cardiotomy cardiogenic shock.
Abiomed touts its Impella heart pumps as the only percutaneous temporary ventricular support devices with FDA approval for cardiogenic shock in the setting of cardiomyopathy, according to a press release.
The company also announced a new Women’s Initiative, which will focus on heart recovery education and awareness and comes in conjunction with the new approval covering permpartum and postpartum cardiomyopathy.
“The Impella platform provides a new treatment option for women suffering from cardiogenic shock caused by cardiomyopathy. Additionally, unloading the heart so it can rest has the potential to improve outcomes specifically around heart recovery, for this young postpartum population. Education and patient awareness are also critical to properly diagnose and treat these patients,” Dr. Cindy Grines of Hofstra/Northwell Health said in a prepared statement.
“With our expanded indication, we can invest in education and awareness as we launch our Women’s Initiative for heart recovery. Abiomed will establish a new physician and patient advisory board to make heart recovery the standard of care for women suffering from cardiogenic shock. We are so motivated and inspired to be part of the team that allows these young and otherwise healthy new mothers, like Laura, Kristie and Lauri, to return home to their families with their native heart and live the lives they were meant to have,” prez & CEO Michael Minogue said in a press release.
Earlier this month, Abiomed topped the consensus forecast on Wall Street for its fiscal third-quarter results despite taking a nearly $19 million hit due to the tax reforms enacted last year.
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