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Dive Brief:
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Johnson & Johnson said Monday that a pivotal trial for the Impella ECP heart pump met its primary endpoint, positioning the company to seek Food and Drug Administration approval for the device.
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Impella ECP is designed to be easier to insert and implant than other heart pumps. The devices have become a key growth driver for J&J since it acquired Abiomed for $16.6 billion in late 2022.
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J&J reported a 6.3% rate of major adverse cardiac and cerebrovascular events after 30 days, which included death and stroke. The upper limit of the 95% confidence interval was below the predefined target, causing the trial to meet its primary endpoint.
Dive Insight:
Sales at J&J’s Abiomed business grew 16.3% in the third quarter. The company attributed the increase to growth across all regions and continued adoption of the surgically implanted Impella 5.5 and minimally invasive, right-sided heart pump Impella RP. The product line also features Impella CP, another minimally invasive pump, that provides support to patients undergoing high-risk percutaneous coronary intervention (PCI).
J&J is working to add Impella ECP to the portfolio. The device consists of an introducer sheath sized at 9-French in diameter, or 3 millimeters, and a pump sized at 21-French that is compressed for insertion and removal. Impella CP uses a 14-French sheath. J&J has predicted the narrower Impella ECP will be easier to insert and implant and enable the use of small bore access and closure techniques.
The company tested the device in a single-arm pivotal trial that enrolled 256 patients at 18 sites in the U.S. Patients were hemodynamically stable and eligible for high-risk PCI to open up blockages and restore blood flow to the heart.
After 30 days, the rate of major adverse cardiac and cerebrovascular events was 6.3%, below the 24.4% performance goal.
Amir Kaki, director of mechanical circulatory support and complex coronary intervention at Henry Ford-St. John Hospital and Medical Center, discussed the goal in his presentation of the data. The target was developed in conjunction with the FDA using prior data sets of high-risk PCI, said Kaki, who is the principal investigator of the study and a paid consultant for Abiomed.
J&J reported eight deaths, five strokes, four heart attacks and two target vessel revascularizations. The adverse events happened in 15 people, resulting in a rate of 6.3%. The upper limit of the 95% confidence interval, which needed to be below the performance goal for the trial to succeed, was 9.5%.