FDA OK’s Biotronik's single-lead ICD system

The FDA has approved Biotronik's Lumax 740 DX System, an implantable cardioverter-defibrillator (ICD) that uses a single lead with atrial sensing capabilities.

The DX System expands the diagnostic capabilities of a standard single-chamber ICD with a single lead, in addition to featuring sensors that allow for atrial monitoring and arrhythmia diagnosis. The system utilizes the LinoxsmartS DX lead, a floating atrial dipole that allows physicians, for the first-time in an ICD, to capture atrial sensing capabilities with one lead.

The system combined with the Lumax 740 VR-T DX device provides a reliable atrial signal, according to Berlin-based Biotronik. Additionally, the company said that its SMART Detection algorithms discriminate supraventricular tachycardias, AF and atrial flutter to reduce the risk of inappropriate shocks. The DX System also integrates with Biotronik Home Monitoring, which allows physicians to remotely follow patients’ clinical and device statuses daily.

Biotronik estimated that it will begin U.S. implants in late February or early March.