Biotronik today touted results confirming that its two-lead CRT-DX system provides equivalent therapy compared to conventional three-lead systems.
The CRT-DX systems include a CRT-DX pulse generator and a DX implantable cardioverter-defibrillator (ICD) lead to provide atrial sensing and help reduce complications associated with an additional atrial lead for patients who do not need atrial pacing.
Results published in the Journal of Cardiovascular Electrophysiology showcased the outcomes from 240 patients across 50 centers in the U.S. The patients were selected to identify 120 matched pairs with similar demographic characteristics and had a minimum of six months of follow-up. The primary endpoint was the complication-free rate, with patients recording a mean follow-up time of approximately 1.4 years.
Lake Oswego, Ore.-based Biotronik observed that its CRT-DX system provided similar CRT (cardiac resynchronization therapy) responses and significantly fewer complications compared to a conventional three-lead system.
The findings included complication-free survival favoring the CRT-DX group (92.5% vs. 85%) and lower rates of inappropriate shock in the CRT-DX cohort compared to the CRT-D cohort (0.8% vs. 5.8%).
“The DX technology is unique to Biotronik and it embodies our dedication to developing innovations where technology meets function,” Biotronik CMO Dr. David Hayes said in a news release. “The choice of not using an atrial lead but still maintaining AV synchrony when possible makes sense: it simplifies procedures and helps reduce risk – it is good for patients and physicians alike.”