Pivotal Impella ECP Study Expands Enrollment to Three New Jersey Hospitals

DANVERS, Mass. – Abiomed, part of Johnson & Johnson MedTech¹, announces the first participants have been enrolled in the Impella ECP Pivotal Trial at three hospitals in New Jersey, expanding this study to a second state in the U.S. Patients received Impella ECP support during high-risk percutaneous coronary intervention (PCI) procedures and were enrolled in the trial at Hackensack Meridian Hackensack University Medical Center, Morristown Medical Center and The Valley Hospital.

Male and female patients between 47 and 80 years of age were enrolled in the Impella ECP Pivotal Trial at these hospitals. Up to 256 patients will be enrolled in the Impella ECP Pivotal Trial, which is a single-arm, prospective, multi-center trial that evaluates the rate of major adverse cardiovascular and cerebrovascular events (MACCE) in adult patients who receive Impella ECP support during an elective or urgent high-risk PCI procedures.

“Abiomed is thrilled to collaborate with these three sites on this landmark pivotal trial designed to demonstrate the safety and efficacy of the Impella ECP during high-risk PCI procedures,” said Seth Bilazarian, MD, senior vice president and medical director at Abiomed, Inc. “Impella ECP lowers the barrier to use for patients given its smaller size for insertion and removal, which will allow more physicians to provide hemodynamic support for their high-risk patients in the cath lab.”

Impella ECP is 9 Fr in diameter upon insertion and removal from the body. Once in the body, it expands and supports the heart’s pumping function, providing peak flows up to 5 L/min.

The Food and Drug Administration (FDA) approved the Impella ECP early feasibility study (EFS) in June 2020. Impella ECP received an FDA breakthrough device designation in August 2021, demonstrating that Impella ECP meets the FDA’s stringent requirements for a breakthrough device. Impella ECP is the first mechanical circulatory support device to use the EFS pathway as a steppingstone to a U.S. pivotal study. Additional details about the Impella ECP pivotal study are available here.

Impella ECP is an investigational device limited by federal law to investigational use only.

About Abiomed
Based in Danvers, Massachusetts, USA, Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical technology that provides circulatory support and oxygenation. Our products are designed to enable the heart to rest and recover by improving blood flow and/or provide sufficient oxygenation to those in respiratory failure. For additional information, please visit www.abiomed.com.

About Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized.

^[1] Johnson & Johnson MedTech comprises the surgery, orthopedics, vision and interventional solutions businesses within Johnson & Johnson's MedTech segment.