BioTrace Medical, a small company headquartered in Menlo Park, California, announced that its Tempo Lead temporary intracardiac pacing lead has been cleared in Europe under the CE Mark. The device is intended for cardiac procedures that require external pacing, such as during transcatheter valve replacements, and it is the only active fixation temporary lead anywhere in the world to do that.
BioTrace claims that patients treated using the Tempo Lead will allow patients to begin moving around sooner and to begin their recovery in a conventional telemetry room rather than an ICU. Thanks to retractable stabilizer loops and its soft tip, the Tempo Lead avoids causing tears or emboli to form, reducing fewer potential complications. Moreover, the lead can be used to watch over patient hearts for a number of days after a procedure, to see if post treatment arrhythmias naturally go away. This can help avoid implantations of unnecessary pacemakers, a big additional plus for the device.
The device is already cleared in the United States, where it has been used in more than 3,000 procedures.
Here’s some study data on the Tempo Lead, according to BioTrace:
In a U.S. multi-center retrospective study of 269 patients led by Columbia University Medical Center and presented at the American College of Cardiology’s Annual Scientific Session in 2018, the Tempo Lead was successfully placed in 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. The Tempo lead was left in place post-procedure in 71.6% of the cases, of which 84.1% mobilized out of bed while maintaining stable pace capture with no dislodgment. The study confirmed the 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.
Product page: Tempo Lead …