|Biotronik picked up FDA approval for Lumax 740 DX--courtesy of Biotronik|
Biotronik got the FDA's final approval on Lumax 740 DX, a first-in-class single-lead ICD designed to treat atrial fibrillation that the company says could vastly improve care for many patients.
Here's why the German devicemaker is so optimistic: To date, most physicians treating patients with AF implant two-lead ICDs, with one to shock the heart and the other to sense atrial function. Implanting two leads contributes to higher rates of complications, Biotronik says, and the Lumax 740 DX is a one-lead option that offers the same sensing capabilities without the additional hardware.
The device is the first of its kind to capture atrial sensing capabilities with one lead, Biotronik Executive Vice President Paul Woodstock said, and the company figures it's an appropriate implant for about 71% of U.S. ICD patients--more than 50,000 people.
"The DX System is designed with the patient in mind," Woodstock said in a statement. "Expanding on the benefits of single-chamber ICDs, the DX System provides physicians with atrial sensing and home-monitoring capabilities to monitor for important atrial conditions such as AF."
Lumax 740 DX is already on the market in Europe and around the world, and Biotronik expects to start shipping units stateside in the next few months.
- read the announcement