The federal safety watchdog’s decision affects the Impella 5.0 and Impella LD devices used to treat cardiogenic shock, Danvers, Mass.-based Abiomed said. The company won the original PMA for Impella back in April 2016. Earlier this month the FDA approved a trial of the Impella CP in patients undergoing treatment for a STEMI heart attack.
Abiomed cited the case of 33-year-old Erin Hanussak, who went into cardiogenic shock due to myocarditis, posting an ejection fraction of just 15%. After 12 days of treatment, first with the Impella CP pump and later with the Impella 5.0 (plus physical therapy and walking), her kidney function improved and she was discharged home.
“Early recognition, escalation and a heart team approach are crucial for patients in cardiogenic shock,” Dr. Jacob Abraham, of the Providence St. Vincent Medical Center, said in prepared remarks. “The Impella 5.0 and Impella LD’s ability to provide greater hemodynamic support and unload the left ventricle make them ideal tools for patients like Erin who need longer duration support and will benefit from ambulation.”
ABMD shares, mirroring a market-wide selloff based on fears of an ongoing trade war, were off -3.4% to $250.17 apiece today in early afternoon trading.