Abiomed has started the ST-elevation myocardial infarction door-to-unloading (STEMI DTU) pivotal randomised controlled trial (RCT) to further demonstrate the safety and effectiveness of Impella heart pump.
The study will evaluate whether unloading the heart’s left ventricle for 30 minutes with an Impella heart pump prior to opening blocked arteries will decrease infarct size after a heart attack and lead to a reduction in future heart failure rates.
Interventional cardiologist Dr Kevin Wolschleger has recruited the first patient in the multi-centre trial at Spectrum Health in Grand Rapids, Michigan.
Wolschleger said: “We are honored to be the first to enroll in this important study which builds on earlier research that shows promise for slowing the growing epidemic of heart failure and improving outcomes for heart attack patients around the world.”
The STEMI DTU RCT is the fourth completed or ongoing randomised controlled trial of Impella heart pump
Abiomed intends to recruit 668 patients undergoing treatment for a STEMI heart attack at up to 60 sites in the STEMI DTU RCT.
The trial will include two arms, of which half the patients will be randomised to secure 30 minutes of left ventricular unloading with the Impella CP heart pump prior to reperfusion. The other half will secure immediate reperfusion.
According to the company, the primary endpoint is infarct size as a percent of left ventricular mass, measured at 3-5 days using cardiac MRI.
The STEMI DTU RCT is the fourth completed or ongoing randomised control study of Impella following PROTECT II RCT, STEM DTU pilot RCT and the ongoing DanGer Shock RCT of AMI cardiogenic shock patients.
Impella secured the highest level of regulatory approval from the FDA based on the PROTECT II randomised controlled trial and multiple other FDA audited prospective studies, which showed Impella’s safety and efficacy compared to the intra-aortic balloon pump (IABP).
The Impella 2.5 and Impella CP devices secured FDA PMA approval for the treatment of 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, Impella LD and Impella 5.5 with Smart Assist are the US FDA approved heart pumps for the treatment of heart attack or cardiomyopathy patients in cardiogenic shock.
In addition, the Impella RP secured FDA approval to treat right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.
In May this year, Abiomed announced the commercial availability of its Impella CP along with SmartAssist, designed to improve patient outcomes with advanced algorithms and simplified patient management.
