The trail has showed that unloading the left ventricle with Impella CP for 30 minutes prior to reperfusion in patients presenting with anterior ST-segment elevation myocardial infarction (STEMI) without cardiogenic shock is safe and feasible, compared against Impella patients reperfused immediately.
The prospective, 50-patient, randomized and multi-center trial showed that unloading first and delaying reperfusion by 30 minutes did not increase 30-day major adverse cardiovascular and cerebrovascular events (MACCE) or infarct size compared against the reperfusion arm of the trial.
Abiomed’s study has also demonstrated that it is feasible to delay reperfusion in a heart attack patient by maximum adherence to the 30 minute unloading protocol and 100% Impella CP insertion success in both study arms.
In addition, the unloading of left ventricle for 30 minutes prior to reperfusion allowed to reduce infarct size due to percentage of area at risk among patients with a ST sum greater than 6.
As part of the agreement with the FDA, Abiomed will also carry out a pivotal, multi-center, prospective and randomized controlled trial comparing unloading with delayed reperfusion to the current standard of care.
The company is planning to start the pivotal trial in the following year.
The FDA has approved the safety and feasibility study design, while an independent steering committee will oversee the data and safety of the trial and blinded clinical events blinded clinical events committee independently determines the study endpoints.
Abiomed chairman, president and CEO Michael Minogue said: “We would like to thank the FDA, our dedicated employees, the patients who consented and all the investigators for their efforts to successfully complete this milestone.”
The Impella heart pumps have not yet secured approval for use in STEMI patients without cardiogenic shock.
The Impella 2.5 and Impella CP devices secure FDA approval to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI) such as stenting or balloon angioplasty, to re-open blocked coronary arteries.
The Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0 and Impella LD secured FDA approval to treat heart attack or cardiomyopathy patients in cardiogenic shock.
