Johnson & Johnson (J&J) is set to pursue FDA approval for its Impella ECP heart pump after a pivotal trial demonstrated the device met its primary endpoint. The trial focused on patients undergoing high-risk percutaneous coronary intervention (PCI). The Impella ECP is designed to be more easily inserted and implanted than existing heart pumps, potentially streamlining the procedure and improving patient outcomes.
The single-arm pivotal trial enrolled 256 hemodynamically stable patients at 18 sites across the U.S. These patients were eligible for high-risk PCI to address blockages and restore blood flow to the heart. The study's primary endpoint was the rate of major adverse cardiac and cerebrovascular events (MACCE) at 30 days.
Key Findings
The trial results showed a 6.3% rate of MACCE at 30 days, which included events such as death and stroke. This was below the pre-defined performance goal of 24.4%. The upper limit of the 95% confidence interval was 9.5%, also below the target, leading to the trial's success in meeting its primary endpoint.
J&J reported specific adverse events, including eight deaths, five strokes, four heart attacks, and two target vessel revascularizations. These events occurred in 15 individuals, resulting in the overall 6.3% rate. Major bleeding related to Impella ECP was observed in nearly 6% of patients, while major vascular complications potentially linked to the device occurred in 1.6% of patients. Notably, there were no reports of aortic valve injury or major hemolysis.
Device Details and Clinical Implementation
The Impella ECP features a 9-French introducer sheath (3 millimeters in diameter) and a 21-French pump that is compressed during insertion and removal. This smaller profile contrasts with the Impella CP, which uses a 14-French sheath. J&J anticipates that the reduced size of the Impella ECP will facilitate easier insertion and implantation, as well as enable the use of smaller bore access and closure techniques.
Amir Kaki, director of mechanical circulatory support and complex coronary intervention at Henry Ford-St. John Hospital and Medical Center, and the principal investigator of the study, highlighted the efficiency of the device's delivery. "Despite our concerns about this novel approach to deliver the ECP across the aortic valve without a wire, it's remarkable to note that the average time required for the operators to cross the aortic valve was just over one minute, with a 100% success rate across multiple centers and multiple operators," Kaki said.
The study also examined vascular closure techniques, with most physicians using an 8-French Angio-Seal, which demonstrated a 92% success rate. Other techniques ranged from 72% to 80% success rates.
Broader Data Set
Beyond the pivotal trial, physicians have treated an additional 243 patients through a continued access program. This brings the total data set for Impella ECP to 560 patients, further supporting the device's safety and efficacy profile.
