Biotronik said last week that the FDA approved 2 of its implantable cardioverter defibrillators designed to deliver an ultra-high-energy initial shock.
Lake Oswego, Ore.-based Biotronik said the approval for its Inventra DX also covers its Itrevia DX defibrillators designed for patients with complex heart rhythm conditions.
Biotronik said the DX line is the 1st defibrillator system to use a single lead to provide dual-chamber diagnostic data.
"Physician experts in the field of electrophysiology have indicated that meaningful therapeutic innovations available in Itrevia and Inventra ICDs – like high-energy options, DX systems and CLS – make it easier for physicians to tailor therapy and improve the quality of life for their patients," president Marlou Janssen said in prepared remarks.
Last month Biotronik won FDA approval for another cardiac rhythm management device, the ProMRI Eluna MRI-safe pacemaker. Earlier this month the company said it launched its Pantera Pro balloon catheter for peripheral artery disease in Europe.