BioTrace Medical Achieves FDA Clearance of Temporary Pacing Technology
BioTrace Medical has received FDA 510(k) clearance for the company’s Tempo Lead, which is a temporary pacing device designed for use in procedures in which temporary pacing is indicated, including transcatheter aortic valve replacement and electrophysiology procedures.
The device has an active fixation mechanism, bipolar electrodes and a soft tip. An elastomeric balloon may be inflated to aid passage of the lead through the venous vasculature and into the right ventricle, and aids in orienting the lead.
Results of the first-in-human study of the technology will be presented at the annual Transcatheter Cardiac Therapeutics conference. — Cynthia Jessup