BioTrace Medical Inc.

3925 Bohannon Drive Suite 200

Menlo Park, CA  94025

  • LinkedIn Social Icon
  • Twitter

© 2019  by BioTrace Medical  Inc.

APM003-01 Rev N

The Tempo   Temporary Pacing Lead

®

Rethinking the Temporary Lead

BioTrace Medical’s Tempo Lead incorporates innovations designed for secure and stable cardiac pacing with the goal of reducing complications and allowing patients to ambulate sooner after procedures.

 

The Tempo Lead features a novel active fixation mechanism, bipolar electrodes and a soft tip. Stabilizers provide secure fixation and maintain stable pace capture.

 

An elastomeric balloon may be inflated to aid passage of the lead through the venous vasculature and into the right ventricle, and  aids in wall apposition  during deployment of the stabilizers.

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

A 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. 

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

Tempo Lead Cited by ACC Expert Panel for Management of Post-TAVR Conduction Disturbances 
ACC Expert Panel TAVR Conduction Disturbances

An ACC Expert Panel recently issued an algorithm strategy for managing conduction disturbances associated with transcatheter aortic valve replacement (TAVR). Published in the Journal of the American College of Cardiology, the algorithm categorizes TAVR patients into five groups based on pre-procedural and procedural conduction abnormalities. The Panel recommends that four of the five groups maintain post-procedural temporary pacing for 24 hours (or at least overnight), and the Tempo Lead is specifically mentioned as an important option for these groups of patients. 

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.