Tue, 28-Jun-2022
Monday 08 Jun 2020 , 10:20 am

FDA Approves Abiomed’s First-in-Human Trial of Impella ECP

Impella ECP allows the pump to be inserted at 9 Fr, expand to approximately 18 Fr while pumping blood and recoil back to 9 Fr for removal.
By SIN Bureau
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Abiomed announced the United States Food and Drug Administration (FDA) has approved the company's investigational device exemption application to start an early feasibility study with a first-in-human trial of the 9 French (Fr) Impella ECP heart pump. Impella ECP, which stands for expandable cardiac power, will be studied in high-risk percutaneous coronary intervention (PCI) patients.

The company claims that Impella ECP is the world’s smallest heart pump. It achieves peak flows greater than 3.5 L/min and is delivered through a slender-profile sheath. It is un-sheathed in the descending aorta and expands to approximately 18 Fr. Using a specially designed pigtail, it crosses the aortic valve without a wire, and pumps from inside the ventricle. When the procedure is complete, the pump is re-sheathed back down to 9 Fr and removed with that same profile.

Impella ECP sits across the valve with a soft atraumatic polyurethane cannula that opens only when the pump is flowing. If the pump stops for any reason, this cannula relaxes allowing the valve leaflets to close around it, maintaining valve competency. Impella ECP is intended for short-term mechanical support in patients undergoing a high-risk PCI, to provide both circulatory support and left ventricular unloading.

For interventional cardiologists, vascular access and closure are critical to the success of PCI procedures with mechanical circulatory support. Typically, these procedures require placement of sheaths or cannulas ranging from 13-24 Fr to perform the intervention. Impella ECP allows for a smaller access site, which may increase adoption.

“We are excited about the benefits of this new breakthrough technology, which advances the field of heart recovery,” said Michael R. Minogue, Abiomed’s Chairman, President, and Chief Executive Officer. “Abiomed is making significant investments to develop smaller, smarter, and more connected technology that forms the foundation of the company’s continued leadership in the field of mechanical circulatory support.”

Neha Mule

Neha writes articles on sectors including medicine, food, materials, and science & technology. A qualified statistician, she has the ability to observe and analyze the trends in global markets and write compelling articles that help CXOs in decision making. She is a bookworm and loves to read fiction, lifestyle, science and technology. Neha comes with 6 years of experience in content writing and editing that involves blog writing, preparation of study materials and OERs.

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