Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Abbott's MitraClip Class I Recall Results From Delivery Snafus

This article was originally published in The Gray Sheet

Executive Summary

Abbott plans to require additional training for physicians implanting the mitral valve repair device and to add a new warning to the device’s labeling after nine instances in which users could not properly deploy the system.

You may also be interested in...



MitraClip Medicare Gains: National Coverage Follows Bonus Payment Decision

CMS finalized a national coverage determination for transcatheter mitral valve repair, conditioned on a registry and on minimum facility and experience requirements for hospitals. The policy follows close behind a new-technology add-on payment granted to Abbott’s MitraClip device.

Simplified Clinical Trial Transparency Rules To Go Live In The EU In June

A new version of the EU Clinical Trials Information System’s public portal will integrate the functionalities of the streamlined transparency rules. 

Top-Selling Drugs 2023: Pharma’s $60bn COVID-19 Cliff

Pfizer/BioNTech’s COVID-19 vaccine Comirnaty toppled after recording the highest ever annual sales for a pharmaceutical in 2022, while Novo Nordisk’s Ozempic climbed rapidly. But Merck & Co’s immuno-oncology blockbuster Keytruda was secure in the number one spot in 2023 as COVID-19 receded.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

MT034571

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