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


Cardima in Europe

This article was originally published in The Gray Sheet

Executive Summary

Revelation Helix STX, the "large loop" version of Revelation Helix, features 16 3 mm electrodes for better tissue contact in treating atrial fibrillation in patients with larger pulmonary veins, according to the Fremont, Calif. company. Helix STX is the fifth product in the Revelation line to receive European CE mark authorization, the company announces July 10. Cardima is in discussions with FDA on how to revive a PMA for the Revelation Tx, following a negative advisory panel review in May (1"The Gray Sheet" June 23, 2003, In Brief)...

You may also be interested in...

Cardima PMA revisited

Maker of the Revelation Tx atrial fibrillation catheter plans to meet with FDA to discuss steps the company should take to earn PMA approval. On May 29, FDA's Circulatory System Devices panel voted that Cardima's study of 83 patients with drug-refractory, paroxysmal AF was inadequate to support PMA approval of the device (1"The Gray Sheet" June 2, 2003, p. 3). Cardima said it is reviewing a transcript of the meeting...

Keeping Track: Submissions Galore Start The New Year; US FDA Clears New Indications For Enhertu, Xalkori

The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker

Vaccination Health Next Stop For Dentovations’ Self+ Immunity Supplement Line

Vacci Prep is first “supplement to establish a standard of care for consumers when preparing their immune system for vaccinations,” Dentovations says.




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