• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » FDA approves Abiomed’s Impella ECP clinical trial

FDA approves Abiomed’s Impella ECP clinical trial

June 5, 2020 By Sean Whooley

AbiomedAbiomed (NSDQ:ABMD) announced today that it received FDA investigational device exemption approval to begin a clinical trial for the Impella ECP heart pump.

Impella ECP (expendable cardiac power) will be studied in the early feasibility, first-in-human trial for high-risk percutaneous coronary intervention (PCI) patients, according to a news release.

The prospective, multi-center, non-randomized trial will assess the safety and feasibility of the device with a primary endpoint of successful delivery, initiation and maintenance of adequate hemodynamic support. It will enroll and treat up to five U.S. patients who require revascularization and will expand to additional patients (pending FDA approval) if it is successful. Enrollment will begin later this year.

Danvers, Mass.-based Abiomed touts its Impella ECP as the world’s smallest heart pump with peak flows greater than 3.5 L per minute, delivered through a slender-profile sheath. Using a specially designed pigtail, the pump crosses the aortic valve without a wire and pumps from inside the ventricle.

The heart pump is designed to sit across the valve with a soft, atraumatic polyurethane cannula that only opens when the pump is flowing and relaxes when the pump stops to allow valve leaflets to close around it. It is intended for short-term mechanical support in patients undergoing high-risk PCI.

“We are excited about the benefits of this new breakthrough technology, which advances the field of heart recovery,” Abiomed chairman, president & CEO Michael Minogue said in the news release. “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.”

Filed Under: Cardiac Implants, Cardiovascular, Clinical Trials, Food & Drug Administration (FDA), Regulatory/Compliance, Structural Heart Tagged With: Abiomed, FDA

More recent news

  • A new way to monitor glucose: Glucotrack explains 3-year CBGM implant technology
  • Dexcom continues advances in AI for CGM, type 2 diabetes awareness
  • Tandem continues to deliver more options, benefits for those with diabetes
  • Breaking: Sequel to launch twiist automated insulin delivery system next month
  • Dexcom shares U.S. report on CGM benefits for type 2 diabetes

About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy