The FDA’s concern about the safety profile Medtronic’s (NYSE:MDT) cardiac ablation catheter sent MDT shares down nearly 3 percent yesterday as investors worried about the device’s prospects for approval.
Medtronic Inc. (NYSE:MDT) has a date with the FDA.
The Fridley, Minn.-based medical device maker is slated o go before the watchdog agency’s circulatory systems advisory panel Oct. 27 for a review of its pre-market approval application for the Ablation Frontiers cardiac ablation system.
The device, designed to treat atrial fibrillation, won a nod from Health Canada in August 2010, meaning it’s cleared for market north of the border.
MEDTRONIC COMPLETES ACQUISITION OF ABLATION FRONTIERS MINNEAPOLIS AND CARLSBAD, CALIF.
– Feb. 6, 2009 – Medtronic, Inc. (NYSE: MDT), today announced it has through an affiliated entity, completed the acquisition of privately held Ablation Frontiers, Inc. Under the terms of the agreement announced Jan. 12, 2009, the transaction includes an initial payment of $225 million plus potential additional payments contingent upon achievement of certain clinical milestones.