“Impella ECP is part of Abiomed’s commitment to continually innovate, patent new breakthroughs, and improve patient outcomes by developing smaller, smarter, and more connected technology,” said Michael R. Minogue, Abiomed’s Chairman, President and Chief Executive Officer.
The primary endpoint of the FDA early feasibility study is successful delivery, initiation and maintenance of adequate hemodynamic support and a composite rate of major device-related adverse events during high-risk PCI. The study protocol will enroll and treat up to five U.S. patients who require revascularization. If successful, enrollment will be expanded to additional patients, pending FDA approval.
Impella ECP is an investigational device, limited by federal law to investigational use only.
ABOUT ABIOMED
Based in Danvers, Massachusetts, USA, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart.
Abiomed, Impella, Impella 2.5, Impella 5.0, Impella LD, Impella CP, Impella RP, Impella 5.5, Impella Connect, and SmartAssist are registered trademarks of Abiomed, Inc., and are registered in the U.S. and certain foreign countries. Impella ECP, Impella XR Sheath, Impella BTR, CVAD Study, STEMI DTU and Automated Impella Controller are pending trademarks of Abiomed, Inc.
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