St. Jude Photon DR
This article was originally published in The Gray Sheet
Executive Summary
Dual-chamber, rate responsive, implantable cardioverter defibrillator premarket approval application is submitted to FDA, the firm reports June 14. The 46 cc tachycardia device offers 37 J of stored energy and incorporates Affinity pacemaker technology for treatment of bradycardia as well (1"The Gray Sheet" Feb. 14, p. 12). Approval of the device, "the world's thinnest dual-chamber ICD" at 12.7 mm, is anticipated later this year. St. Jude is counting on the Photon to wrest ICD market share from market leaders Medtronic and Guidant