FDA approves first single-lead ICD with atrial sensing


The US Food and Drug Administration (FDA) has granted final approval to Biotronik for its Lumax 740 DX System. This novel device, according to a company release is a “first-in-class” implantable cardiac defibrillator (ICD) that utilises a single lead with atrial sensing capabilities.

“Until now, our only option to obtain important and useful atrial signal information from patients undergoing defibrillator implantation has been to implant a separate atrial lead. Implanting multiple leads in the heart has been shown to increase the risk of complications (Dewland et al; J Am Coll Cardiol..2011 Aug 30;58(10):1007-13), and the use of dual-chamber devices in patients without a clear indication for the additional atrial lead has received a great deal of attention in recent months. Until now, my approach for patients who do not require atrial pacing has been to implant single-chamber ICDs,” said Bradley P Knight, medical director, Center for Heart Rhythm Disorders at Northwestern Memorial Hospital’s Bluhm Cardiovascular Institute, Chicago, USA. “The DX System addresses a significant gap in ICD therapy.
Patients now have access to the benefits of both dual and single-chamber ICDs without the risk of additional hardware.”

Traditional standard single-chamber ICDs come with limitations. The devices are designed only to sense changes in ventricular rhythm and are unable to sense atrial arrhythmias, such as atrial fibrillation, correctly.
This can result in an increased risk of an inappropriate shock or a stroke if atrial fibrillation is not detected.

The DX System expands the diagnostic capabilities of a standard single-chamber ICD with a single lead, in addition to featuring sophisticated sensors that allow for atrial monitoring and enhanced arrhythmia diagnosis. The system utilises the LinoxsmartS DX lead. Based on proven technology, the Linoxsmart S DX utilises an innovative floating atrial dipole.

According to a company release, this allows physicians, for the first-time in an ICD, to capture atrial sensing capabilities with one lead. When combined with the Lumax 740 VR-T DX device-which has optimised circuitry-the system provides a reliable atrial signal. Additionally, its SMART Detectionalgorithms discriminate supraventricular tachycardias (SVTs), atrial fibrillation and atrial flutter to reduce the risk of inappropriate shocks.

“Electrophysiologists have long searched for effective diagnostics and disease management capability with a less invasive treatment. But the increased regulatory and financial obstacles associated with bringing innovative technology to market was a challenge,” said Thomas Ahern, director of Cardiac Electrophysiology Research at Scripps Clinic. “Biotronik’s commitment to nearly a decade of research for this system has provided electrophysiologists with technology that will allow for better management of cardiac rhythm care for our patients.”

“The DX System is designed with the patient in mind,” said Paul Woodstock, executive vice president of Sales and Marketing. Biotronik, USA. “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 atrial fibrillation. We believe the system has the potential to be appropriate for more than 50,000, or 71%, of US patients who receive an ICD.”

The DX System also integrates with Biotronik Home Monitoring, allowing physicians to remotely follow their DX patients’ clinical and device statuses daily-at anytime, anywhere in the world. The cellular-based system has demonstrated the ability to detect clinically relevant events, including silent, asymptomatic arrhythmias,and device related issues, allowing for earlier medical intervention.

The DX System is now approved and currently available in most international markets (e.g. EU, Japan). The company announced that it expects to begin US implants in late February/early March.