FDA Approves Impella ECP Pivotal Heart Pump and First Patients Enrolled in Pivotal Clinical Trial

Rhea-AI Summary

Abiomed has received FDA approval for the Impella ECP device, which will be used in the Impella ECP Pivotal Trial. The trial, led by Dr. Amir Kaki, will assess major adverse events in patients undergoing high-risk coronary interventions. Two patients have already been enrolled, demonstrating the device's ability to support complex procedures. Impella ECP is the smallest heart pump, enhancing patient safety and efficiency. The trial aims to enroll up to 217 patients and builds on prior FDA designations for the technology.

Positive

• FDA approval for Impella ECP device enhances company's technological leadership.
• First two patients enrolled in the pivotal trial, showing immediate progress.
• Potential to improve patient outcomes and healthcare efficiency.

Negative

• None.

DANVERS, Mass.--(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).

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.

View source 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

Source: Abiomed, Inc.

FAQ

What is the purpose of the Impella ECP Pivotal Trial?

The trial aims to evaluate the rate of major adverse cardiovascular and cerebrovascular events in patients receiving Impella ECP support during high-risk percutaneous coronary interventions.

How many patients will be enrolled in the Impella ECP Pivotal Trial?

The trial plans to enroll up to 217 patients in the U.S.

What significant milestone has Abiomed achieved with the Impella ECP?

Abiomed received FDA approval for the Impella ECP device and successfully enrolled the first two patients in its pivotal trial.

What distinguishes the Impella ECP from other heart pumps?

Impella ECP is the smallest heart pump, allowing for smaller vascular access and potentially better patient safety during procedures.