Biotronik, a global medical device manufacturer based in Berlin, Germany, announced that it received approval from the United States Food and Drug Administration for its Lumax 740 DX System. The Lumax 740 DX System is a cardioverter defibrillator that features a single lead with specialized sensing technologies. The device is designed for implantation in a patient.
According to a press release by the company, the Lumax 740 DX system includes specialized sensors to detect arrhythmia and other cardiac events. With a floating atrial dipole, the LinoxsmartsS DX lead includes atrial sensing capabilities in a unified package.
The system also includes SMART Detection algorithms to quickly and accurately detect supraventricular tachycardias and atrial flutter. By differentiating between different types of cardiac events, the system reduces inappropriate and unnecessary shocks. With the Biotronik Home Monitoring system, patients with the DX System can share biometric information with their physicians and healthcare providers.
The company expects to implant the first device in the United States later this month or in March.