Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA Appears Ready To Approve Abiomed's Impella Pumps For Cardiogenic Shock By Mid-Year

This article was originally published in Clinica

Executive Summary

The US FDA will not ask its Circulatory System Devices Panel to review Abiomed’s PMA supplement for a cardiogenic shock indication for its Impella line of ventricular assist devices, according to the company.

You may also be interested in...



Medtronic Adds UK-Based Digital Surgery To Support Robotic Surgery

Digital Surgery, a London-based developer of surgical artificial intelligence, analytics, digital education and training solutions, will join Medtronic’s surgical robotics business within its minimally invasive therapies group.

Device Week, 12 February 2020 – A Close-Up On AbioMed's Plan To Counter Unfavorable Impella Data

In this edition of Device Week, Medtech Insight's managing editor Marion Webb talks with deputy editor Reed Miller about his recent story on Abiomed's plan to counter unfavorable studies of its Impella heart pump.

[Editor's note: This article was updated on 14 February 2020 to clarify that Abiomed has invested more than $100m over the past five years in clinical research on the Impella heart pump platform. Abiomed has not committed to spend another $100m on new physician education and communication programs.]

Abiomed Launches Plan To Counter Unfavorable Impella Data

Abiomed is trying to counter the negative publicity created by the recent publication of retrospective studies showing higher costs and worse outcomes in coronary intervention cases with Impella than in comparable procedures with intra-aortic balloon pumps. The company insists this analysis is deeply flawed.

Topics

UsernamePublicRestriction

Register

MT103297

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel