Johnson & Johnson (J&J) recently announced that a key trial for its Impella ECP heart pump has achieved its primary endpoint, bringing the company closer to obtaining approval from the Food and Drug Administration (FDA) for this medical device. The Impella ECP is engineered to be more straightforward in both insertion and implantation compared to other heart pumps, and it has emerged as an essential growth element for J&J following its acquisition of Abiomed for $16.6 billion towards the end of 2022.
In the trial, J&J reported a 6.3% occurrence of major adverse cardiac and cerebrovascular events (MACCE) after 30 days, which included incidents of death and stroke. This percentage was significantly lower than the predefined performance target, with the upper limit of the 95% confidence interval standing at 9.5%, thus enabling the trial to meet its primary goal.
Sales within J&J’s Abiomed division have seen an increase of 16.3% in the third quarter, attributed to growth across various regions and the continued adoption of devices like the surgically implanted Impella 5.5 and the minimally invasive right-sided heart pump, Impella RP. Another device in this line, the Impella CP, also minimally invasive, has been aiding patients undergoing high-risk percutaneous coronary intervention (PCI).
The Impella ECP device features a 9-French diameter introducer sheath (approximately 3 millimeters) and a 21-French sized pump that is compressed during insertion and removal. This compares to the 14-French sheath used by the Impella CP, illustrating the more streamlined design of the ECP which is expected to simplify procedures involving small bore access and closure techniques.
The device was evaluated in a pivotal, single-arm study that recruited 256 U.S. patients at 18 different sites. These patients were hemodynamically stable and eligible for high-risk PCI procedures aimed at eliminating blockages and restoring blood flow to the heart. With a MACCE rate of 6.3% after 30 days — well below the 24.4% performance target — the trial was deemed a success.
The trial’s principal investigator and FDA consultant, Dr. Amir Kaki, director of mechanical circulatory support and complex coronary intervention at Henry Ford-St. John Hospital and Medical Center, highlighted the device’s efficiency. Despite initial concerns on delivering the ECP across the aortic valve without a guiding wire, the device’s wireless delivery approach was highly successful. The average time taken to cross the aortic valve was just over a minute, achieving a 100% success rate across various centers and operators.
Regarding vascular closure techniques post-device application, physicians were given the choice of method. The preferred and most effective was found to be using an 8-French Angio-Seal, securing a 92% success rate. The success rates for other techniques ranged between 72% and 80%.
Furthermore, following the conclusion of the trial, physicians continued to use the device for an additional 243 patients under a continued access program, bringing the total number of patients to 560. This additional data further supports the device’s efficacy and safety profiles.
This trial and the subsequent preliminary adoption of the Impella ECP illustrate the potential of the device to become an integral component of J&J’s cardiology product portfolio. With further regulatory steps and continued successful outcomes, the Impella ECP might revolutionize approaches to cardiac surgery with its less invasive, yet highly effective, operational capabilities.
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