FDA Approves Impella ECP Pivotal Heart Pump and First Patients Enrolled in Pivotal Clinical Trial
22 December 2022 - 1:00AM
Business Wire
Abiomed (Nasdaq: ABMD) announces the United States Food and Drug
Administration (FDA) has approved the version of Impella ECP that
will be used in the Impella ECP Pivotal Trial, and the first two
patients have been enrolled in the trial. Amir Kaki, MD, director
of mechanical circulatory support at Ascension St. John Hospital in
Detroit, led the procedures. This single-arm, prospective,
multi-center trial will evaluate the rate of major adverse
cardiovascular and cerebrovascular events (MACCE) in adult patients
who receive Impella ECP support during an 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)
Impella ECP is the world’s smallest heart pump and the only
heart pump compatible with small bore access and closure
techniques. It is 9 Fr in diameter upon insertion and removal from
the body. Once in the body, it expands and supports the heart’s
pumping function, providing peak flows up to 5 L/min.
Both patients enrolled in the trial received Impella ECP support
during challenging left main coronary bifurcation stent procedures
involving heavily calcified lesions. After Impella ECP was removed,
the first patient was closed with an 8 Fr closure device.
“The research and clinical teams at Ascension St. John are
delighted about enrolling the first patients in the Impella ECP FDA
Pivotal Trial,” said Dr. Kaki, who is national principal
investigator of this study. ”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,” said Mike Minogue,
Abiomed’s Chairman, President and Chief Executive Officer. “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.”
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 using the pivotal clinical
trial protocol. Impella ECP received FDA breakthrough device
designation in August 2021. This designation demonstrates that
Impella ECP meets the FDA’s stringent requirements for 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 U.S. Additional details about the pivotal trial are
available here.
Impella ECP is an investigational device limited by federal law
to investigational use only.
ABOUT ABIOMED Based in Danvers, Massachusetts, USA,
Abiomed (Nasdaq: ABMD) is a leading provider of medical technology
that provides circulatory support and oxygenation. Our products are
designed to enable the heart to rest and recover by improving blood
flow and/or provide sufficient oxygenation to those in respiratory
failure. For additional information, please visit abiomed.com.
FORWARD-LOOKING STATEMENTS Any forward-looking statements
are subject to risks and uncertainties such as those described in
Abiomed's periodic reports on file with the Securities and Exchange
Commission. Actual results may differ materially from anticipated
results.
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version on businesswire.com: https://www.businesswire.com/news/home/20221221005143/en/
Media Contact: Jenny Leary Associate Director, U.S.
Communications +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
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