12/21/2022, 5090 characters
Abiomed (NASDAQ: ABMD) announces U.S. Food and Drug Administration (FDA) approval of the Impella ECP. The approval relates to the version of the Impella ECP to be used in the pivotal Impella ECP study. The first two patients have now been registered for this study. Amir Kaki, MD, director of the Department of Mechanical Circulatory Support at Ascension St. John Hospital in Detroit, led the procedures. This single-arm, prospective, multi-center study will evaluate the incidence of major adverse cardiovascular and cerebrovascular events (MACCE) in adult patients assisted with Impella ECP during elective or urgent high-risk percutaneous coronary intervention (PCI).
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Impella ECP, the world’s smallest heart pump, is placed percutaneously into the heart’s left ventricle. (Graphic: Business Wire)
The Impella ECP is the world’s smallest heart pump and the only one to date that is compatible with small caliber access sites and closure techniques. When inserted and removed from the body, it is 9 charrière (charr) in diameter. In the heart, it expands and supports the heart’s pumping function at peak volume flows of more than 5 l/min.
Both patients enrolled in the study received Impella ECP support during a challenging left aorta coronary bifurcation stenting procedure with heavily calcified lesions. After removing the Impella ECP, the first patient was closed with an 8 Charr closure device.
“The research and clinical teams at Ascension St. John welcome the enrollment of the first patients in the Impella ECP-FDA pivotal study,” said Dr. Kaki, the lead investigator at the national level. “The Impella ECP enables physicians to provide critical hemodynamic support during high-risk PCI procedures by delivering similar or higher flow rates through a smaller introducer sheath compared to other options. This technology has the potential to improve patient safety and throughput in the cath lab by reducing the arteriotomy required for pump placement.”
“Impella ECP underscores Abiomed’s technological leadership and innovative strength. We broke the small caliber barrier with the development of the world’s smallest heart pump,” said Mike Minogue, Abiomed’s Chairman, President and Chief Executive Officer. “At Abiomed, we strive to create smaller, smarter and more connected technologies that improve patient outcomes for heart disease. I applaud the teams in the medical community and at Abiomed for helping us reach this milestone.”
In June 2020, the FDA approved the early feasibility study (EFS) for the Impella ECP. So far, 54 patients have been treated as part of the EFS. Some of these patients were treated according to the pivotal clinical study protocol. In August 2021, the FDA recognized the Impella ECP as a Breakthrough Device. This rating demonstrates that the Impella ECP meets the stringent FDA requirements for breakthrough devices. The pivotal Impella ECP clinical trial (Impella ECP Pivotal Clinical Trial) was approved by the FDA on March 2, 2022 and will enroll up to 217 patients in the United States. More information on the pivotal study can be found here here.
The Impella ECP is an investigational device, the use of which is restricted by US federal law to research applications only.
Headquartered in Danvers, Massachusetts (USA), Abiomed (Nasdaq: ABMD) is a leading provider of medical devices for circulatory support and oxygenation. Our products relieve the heart and support its recovery by improving blood flow and ensuring adequate oxygenation in patients with respiratory failure. Further information is available online at abiomed.com.
FORWARD LOOKING STATEMENTS
Forward-looking statements involve risks and uncertainties as described in Abiomed’s periodic reports filed with the Securities and Exchange Commission. Actual results could differ materially from expected results.
The source language in which the original text is published is the official and authorized version. Translations will be included for a better understanding. Only the language version that was originally published is legally valid. Therefore, compare translations with the original language version of the publication.
View original version on businesswire.com: https://www.businesswire.com/news/home/20221221005144/de/
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