The Tempo Lead Advantages
The incremental procedure cost to treat a cardiac perforation caused by cardiac lead placement can exceed $100,000*. The Tempo Lead’s unique design virtually eliminates perforation risk, provides secure and stable temporary pacing, and allows patients to ambulate sooner after procedures such as TAVR.
Maintain rapid pacing during TAVR valve placement
Free up critical ICU/CCU beds
Safely mobilize patients
Reduce length of stay (LOS)
Proven Safe and Effective in a US Multi-Center Study
Results from a study of 269 patients from six US centers** confirm the Tempo Lead is safe and effective for temporary cardiac pacing, provides stable peri- and post-procedural pacing support, and facilitates post-procedure ambulation.
Perforations, effusions, or arrhythmias
Mean pace capture
Final mean pace
*Cantillon DJ et al., Complications and Health Care Costs Associated With Transvenous Cardiac Pacemakers in a Nationwide Assessment, JACC: Clinical Electrophysiology, Volume 3, Issue 11, 2017, Pages 1296-1305,ISSN 2405-500X, https://doi.org/10.1016/j.jacep.2017.05.007
**Nazif TM et al., The initial U.S. experience with the Tempo active fixation temporary pacing lead in structural heart interventions. Catheter Cardiovasc Interv. 2019;1–6. https://doi.org/10.1002/ccd.28476
Innovation Designed to Eliminate Complications
and Reduce Costs
Active Fixation Mechanism
Small atraumatic stabilizer loops are deployed and retracted using the handle, providing secure fixation and maintaining stable pace capture.
Soft Distal Tip
Unlike the hard, rigid distal tip of a conventional lead that can cause myocardial perforation, the Tempo Lead's soft distal tip virtually eliminates perforation risk.
Asymmetric Elastomeric Balloon
The 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.
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 Medical's devices beyond those that have been cleared by the U.S. Food and Drug Administration or any foregoing equivalent, as applicable.