Abiomed cites positive Impella 2.5 study

September 22, 2009 by MassDevice staff

The cardiac assist device maker, citing the USpella trial, says its Impella 2.5 heart pump is safe and easy to use during high-risk coronary interventions and heart attack treatments.

Abiomed Inc., citing a study of its Impella 2.5 heart pump, said the device is safe and easy to use during high-risk percutaneous coronary intervention and treatment of heart attacks.

The Danvers, Mass.-based cardiac assist device maker said the USpella study involved 181 patients who underwent high-risk PCI and acute myocardial infarction treatments using the device, which is a small pump inserted into the heart via catheter during cardiac procedures.

Abiomed said the data indicate that high-risk PCI patients in the study, 64 percent of whom were deemed ineligible for coronary artery bypass graft surgery, showed improved levels of heart function (ejection fraction, a measure of how well the organ is pumping). Those patients also showed a low incidence (6 percent) of major adverse cardiac events and a 30-day survival rate of 97 percent.

The MCI patients were treated using the device after other, conventional treatments failed. The study showed that those patients also exhibited improved ejection fractions. In cases where the patients went into shock despite intervention, 69 percent survived until the next therapy or recovered; 58 percent of the shock patients were discharged. Eighty-nine percent of patients with no shock were discharged as well.

Abiomed rode sales of its Impella line, which made up more than 60 percent of its fiscal 2010 first-quarter sales, to reach $19.9 million in revenues for the quarter. That's a nearly 22 percent improvement over the same period during the prior year and helped create a nearly 15 percent reduction in quarterly losses ($7.8 million, compared with a net loss of $9.4 million during Q1 2009).