FDA approves single-lead ICD with atrial sensing

Biotronik announced FDA approval of the Lumax 740 DX System, an implantable cardioverter defibrillator that utilizes a single lead with atrial sensing capabilities, according to a press release.

The DX System features new sensors that allow for atrial monitoring and enhanced arrhythmia diagnosis. The system utilizes the LinoxsmartS DX lead, which uses an innovative floating atrial dipole to allow physicians to capture atrial sensing capabilities with one lead. Additionally, the technology uses SMART Detection algorithms to discriminate supraventricular tachycardias, AF and atrial flutter to reduce risk for inappropriate shocks. The DX System integrates with Biotronik Home Monitoring so physicians can remotely follow their patients’ clinical and device statuses daily, according to the release.

“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, 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,” Bradley P. Knight, MD, medical director, Center for Heart Rhythm Disorders at Northwestern Memorial Hospital’s Bluhm Cardiovascular Institute, stated in the release.

“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,” Knight stated.

The company expects to begin US implants in late February or early March, according to the release.