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

Dueling Commentaries In JAMA Revisit US FDA Approval Of Abiomed’s Impella

This article was originally published in Clinica

Executive Summary

Is the US FDA’s 515 Program Initiative for so-called “pre-amendment” technologies, leading to approvals of high-risk devices, based on flawed evidence? This question is addressed by two expert commentaries, posted online by JAMA Cardiology on March 9, that review the US FDA’s 2015 approval of Abiomed’s Impella 2.5 percutaneous ventricular assist device under the 515 Program Initiative.

You may also be interested in...



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.

Inspira Goes Public To Develop Its Alternative To Mechanical Ventilation

The Israeli company raised $16m to support its Augmented Respiration Technology, a novel approach for delivering oxygen directly into the venous system. The company expects to earn FDA clearance for first product by 2023.

Abbott’s Q2 Medical Device And Diagnostic Sales Surpass 2019 Levels

Abbott expects the ongoing recovery of medical procedure volumes to continue even as new virus variants are causing COVID-19 cases to increase in some geographies.

Topics

UsernamePublicRestriction

Register

MT103276

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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