Temporary pacing technology firm BioTrace Medical has secured the European CE-Mark for the use of its Tempo Lead in cardiac procedures that require temporary intracardiac pacing.
The Tempo Temporary Pacing Lead has been designed to deliver safe and stable pacing to mitigate intraprocedural complications, including perforation and valve embolisation.
The lead enables patients to ambulate sooner following procedures such as TAVR and TMVR, facilitating faster recovery times, and enabling patient transfer directly to a telemetry unit rather than an ICU or CCU.
Comprising retractable stabiliser loops and a soft tip, the device reduces dislodgment risks and perforation, as well as ensures stability during rapid pacing.
The device received US Food and Drug Administration (FDA) clearance in October 2016. It is said to be only active fixation temporary pacing lead.
BioTrace Medical CEO Laura Dietch said: “Since receiving FDA clearance, the Tempo Lead has been used in more than 3,000 US procedures with a safety and performance profile superior to conventional temporary leads. The Tempo Lead is quickly becoming the standard of care for fast-growing procedures like TAVR.
“We credit the success of the Tempo Lead to its clinical benefits over traditional temporary pacing leads, improved patient outcomes due to decreased complications.”
The company noted that results from a 269-patient multi-centre study led by Columbia University Medical Center in the US have been presented at the American College of Cardiology’s Annual Scientific Session in 2018.
Findings revealed that the Tempo Lead was placed in 98.1% of the cases without any cardiac perforations, pericardial effusions or sustained device-related arrhythmias and only a 0.8% loss of pace capture.
Out of the 71.6% cases that had the lead left in place post-procedure, 84.1% mobilised out of bed and maintained stable pace capture without dislodgment.
In addition, the Tempo Lead was found to be safe and effective for temporary cardiac pacing.