Biotronik’s Lumax 740 DX receives US approval

Biotronik has announced that its Lumax 740 DX innovative implantable cardiac defibrillator has been granted US regulatory approval.

The Food and Drug Administration has given final approval to the first-in-class device, which utilises a single lead with atrial sensing capabilities, making it safer and posing a lower risk of complications than devices with multiple leads.

Offering integration with the Biotronik Home Monitoring system, the device could offer a potential new option for the 50,000 US patients who may benefit from atrial sensing without a pacing indication.

The Lumax 740 DX System is now approved and available in most international markets, including the EU, with US implants to begin later this month or early in March.

Paul Woodstock, executive vice-president for sales and marketing at Biotronik in the US, said: "The DX System provides physicians with atrial sensing and home monitoring capabilities to monitor for important atrial conditions such as atrial fibrillation."

This comes after the firm received European CE Mark approval for its Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronisation therapy defibrillator earlier this month.