Abiomed receives FDA approval for heart pump clinical trial
pharmafile | December 22, 2022 | News story | Research and Development |
Abiomed, a leading provider of medical technology focusing on the circulatory system and oxygenation, has announced that the FDA has approved its Impella ECP for clinical trials, and that the first two patients have been enrolled.
Impella ECP is the world’s smallest heart pump, and the only one compatible with small bore access and closure techniques. It is only 9Fr in diameter upon insertion and extraction, but when inside the body, it expands and supports the heart’s function, providing peak flows of 5L/min.
Dr. Kaki, who is national principal investigator of this study, stated, “The research and clinical teams at Ascension St. John are delighted about enrolling the first patients in the Impella ECP FDA Pivotal Trial. Impella ECP advances the opportunity for physicians to provide critical hemodynamic support during high-risk PCI procedures by delivering similar or higher flow compared to other options through a smaller vascular sheath for access. This technology has the potential to improve patient safety and cath lab throughput because of the smaller arteriotomy required for pump placement.”
“Impella ECP demonstrates Abiomed’s leadership in technology and innovation as we have broken the small-bore barrier through the development of the world’s smallest heart pump. At Abiomed, we remain committed to developing smaller, smarter and more connected technologies that will improve outcomes for patients with heart disease. I applaud the teams within the medical community and at Abiomed who helped us achieve this milestone,” furthered Mike Minogue, Abiomed’s chairman, president and chief executive officer.
James Spargo
