BioTrace Medical, an innovative temporary pacing technology provider, has obtained CE Mark certification in Europe for its Tempo Lead, used in cardiac procedures requiring temporary intracardiac pacing.
BioTrace said that it has designed Tempo Temporary Pacing Lead to deliver safer, more secure and stable pacing to reduce intraprocedural complications, including perforation and valve embolization.
In addition, it enables patients to ambulate sooner after procedures such as TAVR and TMVR, accelerating recovery times, and enabling patient transfer directly to a step-down or telemetry unit instead of an ICU or CCU.
The company’s Tempo Lead was cleared by the US FDA in October 2016, and marks the only active fixation temporary pacing lead available in the world.
BioTrace said that its unique design featuring novel retractable stabilizer loops and a soft tip mitigates the risks of dislodgment and perforation and ensures stability during rapid pacing.
BioTrace Medical CEO Laura Dietch said: “Obtaining CE Mark for the Tempo Lead is another significant milestone for the BioTrace Medical team. Since receiving FDA clearance, the Tempo Lead has been used in more than 3,000 U.S. 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. We are pleased the Tempo Lead’s advantages are also helping improve economic outcomes for hospitals and allows them to efficiently utilize scarce resources especially in the ICU.”
The company said that the Columbia University Medical Center has conducted a multi-center retrospective study in the US involving 269 patients and presented the study results at the American College of Cardiology’s Annual Scientific Session.
The study results showed that in 2018, the Tempo Lead has placed 98.1% of the cases with no cardiac perforations, pericardial effusions, or sustained device-related arrhythmias and only a 0.8% loss of pace capture.
In addition, the study confirmed that Tempo Lead is safe and effective for temporary cardiac pacing, provides stable peri- and post-procedural pacing support, and facilitates post-procedure ambulation, which can safely allow direct transfer to step-down or telemetry units with no ICU time required, reducing length of stay.