Abiomed announces that the U.S. Food and Drug Administration has approved the version of the Impella ECP that will be used in the pivotal trial of the Impella ECP device, as well as the recruitment of the first two patients in this trial. Amir Kaki, MD, director of mechanical circulatory support at Ascension St. John Hospital in Detroit, conducted the procedures. This multicenter, prospective, single-group trial will assess the rate of major adverse cardiovascular and cerebrovascular events in adult patients who receive Impella ECP support during elective or high-risk emergency percutaneous coronary intervention (PCI).

The Impella ECP is the world's smallest heart pump and the only one compatible with small orifice access and closure techniques. It has a diameter of 9 Fr when inserted and removed from the body. Once inserted into the body, it expands and supports the pumping function of the heart, providing peak flow rates up to 5 L/min.

Both patients enrolled in the trial received Impella ECP assistance during challenging left main coronary stent insertions involving heavily calcified bifurcation lesions. After removal of the Impella ECP, the first patient's device was closed with an 8 Fr closure.

" The research and clinical team at Ascension St. John are very pleased to have enrolled the first patients in the pivotal FDA-approved trial of the Impella ECP," said Dr. Kaki, national principal investigator of the study. “ The Impella ECP offers physicians the ability to provide critical hemodynamic support during high-risk PCI by delivering similar or greater flow than other options using a smaller sheath. vascular access. This technology has the potential to improve patient safety and catheter lab throughput due to a smaller arteriotomy required for pump placement.”

" The Impella ECP is a testament to Abiomed's leadership in technology and innovation, as we have overcome the pitfall of small orifices by developing the world's smallest heart pump," said Mike Minogue, Chairman, President and CEO of Abiomed. “ At Abiomed, we remain committed to developing smaller, smarter and more connected technologies that will improve outcomes for heart disease patients. I congratulate the teams in the medical community and Abiomed who made it possible for us to achieve this”.

In June 2020, the FDA approved the Impella ECP Early Feasibility Study (EFS). Fifty-four patients have been treated to date in the EFS, including some patients treated according to the protocol of the pivotal clinical trial. The Impella ECP received Breakthrough Device Designation from the FDA in August 2021. This designation demonstrates that the Impella ECP meets the FDA's strict requirements as a Breakthrough Device. The Impella ECP pivotal clinical trial received FDA approval on March 2, 2022 and will enroll up to 217 patients in the United States. Additional information about the pivotal trial is available here .

The Impella ECP is an investigational device restricted by federal law to experimental use only.

ABOUT ABIOMED
Based in Danvers, Massachusetts, USA, Abiomed (Nasdaq: ABMD) is a leading provider of circulatory support and oxygenation medical technologies. Our products are designed to allow the heart to rest and recover by improving blood flow and/or to provide sufficient oxygenation for people with respiratory failure. For more information, please visit abiomed.com .

FORWARD- LOOKING STATEMENTS
All forward-looking statements are subject to risks and uncertainties as described in Abiomed's periodic reports filed with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

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contacts
Media Contact:
Jenny Leary
Associate Director, Communications, US
+1 (978) 882-8491
jleary@abiomed.com

Investor Contact:
Todd Trapp
Executive Vice President and Chief Financial Officer
+1 (978) 646-1680
ttrapp@abiomed.com

 

Source:businesswire.com

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