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


St. Jude: CardioMEMS’ Heart Failure Data Reflects Major Opportunity

This article was originally published in The Gray Sheet

Executive Summary

With the publication of the CHAMPION clinical trial results, CardioMEMS and its suitor St. Jude Medical took another step toward leading the pack in what they say is a multi-billion dollar market opportunity in hemodynamic heart failure monitoring.

You may also be interested in...

CardioMEMS Has Better Luck With FDA Advisory Panel Second Time Around

FDA’s Circulatory System Devices panel wrestled with a new analysis of the CHAMPION trial of the Champion heart failure monitor Oct. 9. CardioMEMS was banking that the new analysis would eliminate the doubts about possible bias that undermined the company’s first effort to earn FDA approval in 2011.

CardioMEMS’ Heart Failure Monitor Foiled At Panel By FDA Inspection Findings Of Study Bias

The firm’s PMA hopes are in question after recommendations made by company nurses to investigators in the CHAMPION trial, uncovered during FDA clinical-site inspections, dominated last week’s advisory panel meeting. The panel voted 6-4 that the benefits of the device do not outweigh its risks.

FDA Approves St. Jude’s Quadripolar CRT-D Device Following Delay

The approval is significant as it marks the entry of the first quadripolar pacing system into the U.S. market. But St. Jude may not get as big of a positive gain from the product as previously expected, analysts suggest.

Related Content


Latest Headlines
See All



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