Abiomed (NSDQ:ABMD) announced today that it received FDA investigational device exemption approval to begin a clinical trial for the Impella ECP heart pump.
Impella ECP (expendable cardiac power) will be studied in the early feasibility, first-in-human trial for high-risk percutaneous coronary intervention (PCI) patients, according to a news release.
The prospective, multi-center, non-randomized trial will assess the safety and feasibility of the device with a primary endpoint of successful delivery, initiation and maintenance of adequate hemodynamic support. It will enroll and treat up to five U.S. patients who require revascularization and will expand to additional patients (pending FDA approval) if it is successful. Enrollment will begin later this year.
Danvers, Mass.-based Abiomed touts its Impella ECP as the world’s smallest heart pump with peak flows greater than 3.5 L per minute, delivered through a slender-profile sheath. Using a specially designed pigtail, the pump crosses the aortic valve without a wire and pumps from inside the ventricle.
The heart pump is designed to sit across the valve with a soft, atraumatic polyurethane cannula that only opens when the pump is flowing and relaxes when the pump stops to allow valve leaflets to close around it. It is intended for short-term mechanical support in patients undergoing high-risk PCI.
“We are excited about the benefits of this new breakthrough technology, which advances the field of heart recovery,” Abiomed chairman, president & CEO Michael Minogue said in the news release. “Abiomed is making significant investments to develop smaller, smarter, and more connected technology that forms the foundation of the company’s continued leadership in the field of mechanical circulatory support.”