BioTrace Medical Inc.

3925 Bohannon Drive Suite 200

Menlo Park, CA  94025

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© 2019  by BioTrace Medical  Inc.

APM003-01 Rev N

Tempo  Lead Clinical Results

®

Safe and Reliable Temporary Pacing with Post-Procedure Ambulation Demonstrated in Multi-Center US Study

This multicenter retrospective study of the initial U.S. experience evaluated the safety and efficacy of temporary cardiac pacing with the Tempo® Temporary Pacing Lead.  The Tempo lead was successfully positioned in the right ventricle and achieved pacing in 264 of 269 patients (98.1%). Two patients (0.8%) experienced loss of pace capture. Procedural mean pace capture threshold (PCT) was 0.7 ± 0.8 mA. There were no perforations, pericardial effusions, or sustained device-related arrhythmias. The Tempo lead was left in place post-procedure in189 patients (71.6%) for mean duration of 43.3 ± 0.7 hr (range 2.5–221.3 hr) with final PCT of 0.84 ± 1.04 mA (n = 80). Of these patients, 84.1% mobilized out of bed, all with no lead dislodgment. 

 Tempo Lead J INVASIVE CARDIOL 2018 February 15 (Epub Ahead of Print)
Rapid Pacing for TAVR with Reliable Pace Capture and No Perforations 

Results from the first in human Tempo study clearly demonstrated the safety of the Tempo Lead, with no device related adverse events, dislodgments, sustained ventricular arrhythmia, or cardiac perforations. Pacing with the Tempo Lead was successful in all treated patients with no loss of pace capture or lead dislodgements. Average procedural pace capture threshold was 0.7±0.5mA. 

References:

1. Nazif TM, Chen S, Codner P, et al. The initial U.S. experience with the Tempo active fixation temporary pacing lead in structural heart nterventions. Catheter Cardiovasc Interv. 2019;1–6. https://doi.org/10.1002/ccd.28476

2. Webster M, Pasupati S, Lever N, Stiles M. Safety and Feasibility of a Novel Active Fixation Temporary Pacing Lead.

J Invasive Cardiol. 2018 May;30(5):163-167 Epub 2018 February 15.

Use Per FDA Cleared Labeling

The devices, systems and services described on this Website are subject to United States laws governing the use and sale of such devices, systems and services. Nothing in this Website is intended to constitute a claim or indication for clinical uses of BioTrace’s medical devices beyond those that have been cleared by the U.S. Food and Drug Administration or any foregoing equivalent, as applicable.