The FDA approved new pacemaker technology that may offer a safer option for more than 50,000 patients. Biotronik was granted final approval for the Lumax 740 DX System, the first single-lead implantable cardiac defibrillator (ICD) that uses a single, rather than double, lead with atrial sensing capabilities.
Single-chamber ICDs use one lead, a thin flexible wire, to send an electrical shock to the heart when the heart rate becomes too fast. Of the 70,000 patients in the U.S. who receive an ICD each year, those who have or are at risk for atrial fibrillation benefit the least from single-chamber ICDs, which cannot sense changes in atrial rhythm.
Those patients are sometimes given a dual-chamber ICD, a riskier device that uses two leads. Studies have found that the risk of complication or even death is 40 percent higher with a dual lead than with a single lead.
The new system uses a floating atrial dipole to allow physicians to capture atrial sensing capabilities with one lead. It also contains features that reduce the risk of inappropriate shocks.
"The DX System addresses a significant gap in ICD therapy," said Dr. Bradley Knight, Medical director for the Center for Heart Rhythm Disorders at Northwestern Memorial Hospital's Bluhm Cardiovascular Institute, in a press release. "Patients now have access to the benefits of both dual and single-chamber ICDs without the risk of additional hardware."
It also integrates the Biotronik Home Monitoring, which allows physicians to follow both clinical and device statuses.
The company believes the new device will be appropriate for 71 percent of U.S. patients who receive an ICD. Implants are slated to begin at the end of this month or in early March.