Abiomed ($ABMD) has ended its PROTECT II study of its Impella cardiac assist device based on a recommendation of a data safety monitoring board. The company's shares dipped 14 percent at $10.50 after hours, the Wall Street Journal notes.
PROTECT II was designed to measure major adverse events at 30 days in high risk percutaneous coronary intervention patients randomized to receive hemodynamic support during the procedure with the Impella versus intra-aortic balloon. However, some of the patients in the study had differences in the application of rotational atherectomy that introduced unanticipated variables, as the WSJ notes.
"Atherectomy was an unanticipated variable which resulted from the operators' decision to 'do more with Impella.' Our investigators had unblinded knowledge of the treatment arm after randomization," said William O'Neill, University of Miami and Principal Investigator of the PROTECT II study. "It is interesting that operators felt that they could do more complex interventions once randomized to Impella and this in and of itself is an important finding."
The company did share positive news from the study. For the entire study population, Impella significantly reduced out of hospital major adverse events by 52 percent compared with IAB for the duration of the 90-day monitoring, the company says in a statement.
"With PROTECT II interim results, we now have both the clinical and cost effectiveness data to pave the way to change the standard of care for PCI requiring prophylactic hemodynamic support," Michael Minogue, company chairman, president and CEO, says in a statement. "These data will augment our increasing commercial momentum as we now focus on execution to capture this market opportunity."