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Medical Devices / Submissions and Approvals

BioTrace Medical’s Wins CE Mark for Temporary Pacing Lead

May 13, 2019

BioTrace Medical earned the CE Mark for its Tempo Lead in Europe for use in cardiac procedures requiring temporary intracardiac pacing.

The lead provides stable pacing to reduce complications such as perforation and valve embolization. It can also speed recovery times, enabling patients to transfer to a step-down or telemetry unit instead of an intensive care unit.

In a multi-center retrospective study of 269 patients, the Tempo Lead was successfully placed in 98.1 percent of the cases and was  left in place post-procedure in 71.6 percent of the cases.

The device was cleared by the FDA in October 2016. Since then, it has been used in more than 3,000 U.S. procedures “with a safety and performance profile superior to conventional temporary leads,” according to BioTrace CEO Laura Dietch.

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