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
You may also be interested in...
St. Jude Photon ICD PMA Submission Expected By Mid-Year
St. Jude Medical says it expects to file a premarket approval application with FDA for the Photon DR dual-chamber implantable cardioverter defibrillator by mid-year.
Entries Begin To Roll In For 2024 Industry Awards
Entries have now begun rolling in for the Global Generics & Biosimilars Awards, which returns to Milan this October, Free to enter and attend, the ceremony recognizes the top achievements across the generics, biosimilars and value added medicines industries.
‘I Would Love To Have All The Biologic Assets’ – Formycon’s Glombitza Sets Out Portfolio Approach
In the second part of an exclusive interview, Formycon CEO Stefan Glombitza talks to Generics Bulletin about key regulatory developments in Europe and the US, the firm’s portfolio selection strategy, and upcoming milestones on the horizon.