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, involving 256 patients undergoing high-risk percutaneous coronary intervention (PCI), showed a significantly lower rate of major adverse cardiac and cerebrovascular events (MACCE) than the pre-defined performance goal.
The Impella ECP is designed to be more easily inserted and implanted than existing heart pumps. This device has become a key growth driver for J&J following its $16.6 billion acquisition of Abiomed in late 2022. The company aims to expand its Impella product line with this new device.
Pivotal Trial Results
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 primary endpoint was the rate of major adverse cardiac and cerebrovascular events (MACCE) at 30 days.
The trial results showed a MACCE rate of 6.3%, with the upper limit of the 95% confidence interval at 9.5%. This was below the pre-defined performance goal of 24.4%, which was established in conjunction with the FDA using historical data from high-risk PCI cases. The adverse events included eight deaths, five strokes, four heart attacks, and two target vessel revascularizations, affecting a total of 15 patients.
Device Features and Benefits
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, compared to the 14-French sheath used by Impella CP, is expected to facilitate easier insertion and implantation, as well as enable the use of smaller bore access and closure techniques.
Expert Commentary
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 success of the wireless delivery approach across the aortic valve. "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.
Adverse Events and Vascular Closure
Nearly 6% of patients experienced major bleeding related to the Impella ECP, while 1.6% had major vascular complications. There were no reports of aortic valve injury or major hemolysis. The study also examined different vascular closure techniques, with the 8-French Angio-Seal demonstrating the highest success rate at 92%.
Continued Access Program
Following the trial, physicians treated an additional 243 patients through a continued access program. J&J now has data on a total of 560 patients treated with the Impella ECP.
