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)...